Correspondence to Ms Irene Gibson; [email protected]
WHAT IS ALREADY KNOWN ON THIS TOPIC
During the COVID-19 pandemic, many cardiac rehabilitation (CR) centres adopted new digital health interventions (DHIs) to enable remote delivery of services. While there is emerging evidence to suggest that remotely delivered CR programmes may be effective, more data are needed. Uptake and implementation of these new technologies has been heterogeneous, resulting in widespread variability in service provision. Related to this, exact details of digital CR interventions tend to be poorly described in the literature making it difficult to replicate or build on research findings.
WHAT THIS STUDY ADDS
Our results demonstrate that it is feasible to implement comprehensive digital CR programmes and achieve measurable improvements in medical and lifestyle risk factors and psychosocial health.
Furthermore, using the Template for Intervention Description and Replication, we describe the process of developing a DHI for the remote delivery of CR and provide a detailed overview of the key intervention features.
HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY
Our study highlights the potential for digital CR programmes to improve accessibility and uptake of evidence-based CR. However, to achieve optimal patient and health system benefits, these DHIs should incorporate the evidence-based core components of comprehensive CR. We provide details of a digital CR model that could be replicated, and with further research, expanded to complement existing in person CR services.
Introduction
Cardiac rehabilitation (CR) is a class 1 level A recommendation for coronary heart disease (CHD) and heart failure patients, with benefits including reduced cardiovascular disease (CVD) mortality, morbidity and improved quality of life.1 2 However, despite this compelling evidence, data from the EuroAspire V and IAspire surveys indicate that CR utilisation rates across Europe are suboptimal.3 4 Indeed, the majority of CHD patients at pan-European and national levels are not meeting the recommended lifestyle, medical and therapeutic targets.3 4 These challenges have only been exacerbated by the COVID-19 pandemic. However, the pandemic also presented an opportunity to rethink how secondary preventive care is being delivered. For example, it resulted in rapid digital transformation, with increased uptake of digital health interventions (DHIs).5 With up to 75% of CR services being suspended across the globe,6 7 DHIs became essential to providing appropriate and timely patient care. Consequently, 40% of services globally were reported to pivot to digital programme delivery within the first 3 months of the pandemic,6 with uptake rates of home-based CR increasing by as much as 60% (15.9%–76%) in countries such as the UK.8
Digital health refers to the use of information or communication technologies to achieve health outcomes.9 The term encompasses eHealth, mHealth (smart phone apps, wearables, text messaging) and telemedicine. There is a growing evidence, including recent systematic reviews10 to support the use of DHIs for the remote delivery of CR, with data suggesting improved clinical outcomes, health-related quality of life, as well as enhanced patient empowerment and shared decision making.5 10 11 However, more data are needed to confirm the efficacy of these programmes and to establish if benefits observed during these programmes can be sustained over time. Furthermore, with increasing calls for DHIs to play a role in future CR delivery, there is a need to define what ‘optimal’ CR using DHIs looks like. This requires a detailed replicable description of how digital CR programmes were adapted during the pandemic, to what degree they addressed the core components of CR, what DHIs worked for whom and what are the effects on CR participation and patient outcomes.
This analysis aims to examine the outcomes (lifestyle, risk factor, therapeutic goals and quality of life) of a digital CR programme known as Croí MySláinte at 12 weeks and at 6-month follow-up. Using the Template for Intervention Description and Replication (TIDieR) (online supplemental appendix 1),12 we describe the process of developing the programme and provide a detailed overview of the key intervention features of this DHI.
Methods
Study design
This is a single-centre, observational study of patients who attended the Croí MySláinte programme between August and December 2020. To evaluate the effects of the programme, data were collected at baseline, 12 weeks and at 6-month follow-up. Reporting adhered to Strengthening the Reporting of Observational Studies in Epidemiology guidelines (online supplemental appendix 2)13 and the TIDieR (online supplemental appendix 1) checklist.12 Researchers beyond the interdisciplinary team only had access to anonymised data.
Study setting
Croí MySláinte was developed by Croí (Gaelic for heart), an Irish Heart and Stroke patient organisation with European Association of Preventive Cardiology (EAPC) centre accreditation. The programme was designed to enable patients to receive timely access to a structured, comprehensive CR programme that otherwise may not have been available to them due to the COVID-19 pandemic.
The design and development of Croí MySláinte was led by an experienced interdisciplinary team which included a cardiovascular nurse prescriber, specialist cardiac physiotherapist, dietitian, cardiologist (all with postgraduate qualifications in preventive cardiology) with the support of an administrator and eLearning Technologist. The team used their clinical experience, following available international recommendations for remote delivery of healthcare to patients with CVD,14 15 to model Croí MySláinte on the evidence-based in person MyAction programme that had been delivered by Croí before the onset of COVID-19.16 The MyAction programme was a derivative of the EuroAction study.17
Designed to align to EAPC18 and British Association of Cardiac Rehabilitation and Prevention recommendations,19 the core components of Croí MySláinte included: initial and end of programme (EOP) assessment, lifestyle modification (smoking cessation, healthy food choices and physical activity), medical risk factor management (blood pressure, lipids and glucose), psychosocial and behavioural change support, and electronic prescribing of cardioprotective medication where appropriate. Patient outcomes measures were based on the lifestyle, risk factor and therapeutic goals as recommended by the European Society of Cardiology (ESC) best practice guidelines for hypertension,20 dyslipidaemia21 and CVD prevention.22 While identifying ways of objectively measuring these outcomes remotely was challenging, general practitioners (GPs), hospital referral centres and patients played a key role in actively supporting. Programme development took place between May and July 2020 and involved a number of key steps. These are outlined in figure 1.
Recruitment
Eligibility criteria for the programme included; patients (≥18 years of age) who met with guideline recommended inclusion criteria for CR referral,1 access to an ipad/laptop, and a home internet connection. Patients were referred to the programme from cardiology and rehabilitation centres across five sites in the West of Ireland between July and September 2020.
Patient care pathway
The patient care pathway, including a detailed description of the Croí MySláinte intervention, is outlined in figure 2. On receipt of referral, the patient was contacted via telephone by the programme administrator, details of the programme were explained and guidance in the use of the programme technology was provided. Patients were then invited to attend an individual remote assessment (via zoom) with each member of the interdisciplinary team (45 min each). This assessment included: diet (Mediterranean diet score, diet history, current eating habits); anthropometric measurements (weight, height, body mass index); smoking habit (self-reported); physical activity levels (7-day physical activity recall); functional capacity (Chester step test)23; psychosocial health (using three instruments; the Hospital Anxiety and Depression Scale (HADS), EuroQOL-Visual Analog Scale (EQ-VAS visually assessed quality of life scale, and the EQ 5 Dimension 5 Level (EQ-5D-5L) measure of health status; blood pressure (measured using an A&D UA 651 device), fasting lipids, glucose and glycosylated haemoglobin (diabetes patients only) and prescribed medications. The assessment helped to identify the individual’s priorities and needs to reduce their CVD risk, as well as exploring health beliefs, barriers and motivators to change. To help standardise data collection and to ensure a personalised, safe programme of care, anthropometric measures and functional capacity were assessed by the referring centres (in person) and communicated using a standardised electronic referral form. Lipids and glucose were measured by the patient’s GP and blood pressure was self-assessed by the patient using a clinically validated home monitoring device. Patients also completed questionnaires online using the programme platform and were provided with access to a video tutorial to guide self-measurement of blood pressure.
The programme was delivered over a 12-week period using a bespoke web-based platform called Moodle Learning (V.3.9.4), which can host a wide range of interactive educational resources, including prerecorded videos and embedded links to weekly online sessions. Delivered over 2 hours by the interdisciplinary team, the online group based sessions (delivered via zoom) included a supervised exercise component (1 hour) and an educational workshop (topics are outlined in figure 2). These online sessions were facilitated in groups of 12–15. Opportunities for individual engagement with the interdisciplinary team were provided through email and telephone support.
The programme placed a strong emphasis on self-management by using specific behavioural change strategies, including motivational interviewing, brief intervention and goal setting. Patients were provided with a range of self-monitoring tools. These included a blood pressure monitor for home measurement, an accelerometer based Fitbit to track steps, heart rate and exercise progression, food and exercise diaries, and a workbook to support goal setting and overall tracking of progress. The objective was to equip individuals with the knowledge skills and confidence to make changes to their lifestyle in a realistic way that can be sustained long term. Exercise was progressed weekly through individualised exercise prescription guided by the specialist cardiac physiotherapist. This was informed by the ongoing review of physical activity patterns, reported steps from Fitbit as well as heart rate monitoring and perceived exertion during the supervised exercise session. To enhance safety, individuals were advised to have a family member present during the supervised exercise sessions. Where patients presented with above normal (≥11) HADS scores at baseline assessment, they were offered psychology support. Weekly virtual interdisciplinary team meetings were conducted to review lifestyle, risk factor and therapeutic goals and where necessary, the nurse prescriber optimised medication working in collaboration with the cardiologist, GP and pharmacist.
Following programme completion, we invited patients to attend an online EOP and 6-month follow-up assessment, which followed the same standardised approach as the initial assessment (IA). The exception was functional capacity testing, which could not be assessed at 6 months due to imposed COVID-19 physical restrictions. All data were stored on a secure database hosted by Croí.
Programme modifications
As Croí MySláinte was being implemented, modifications were made in response to patient feedback and the contextual challenges of delivering a newly established digital CR programme during a pandemic. These changes included: moving the consent form and questionnaires online as people faced challenges returning by post due to COVID-19 travel restrictions; the prerecorded educational sessions were shortened from 30 to 15 min; patient support in the use of technology was made available on an ongoing basis rather than for the first few sessions; to help support individual goal setting, patients were offered the opportunity to connect with healthcare professionals directly via email or phone in addition to the online platform. All modifications to the programme were agreed by the interdisciplinary team.
Data analysis
Patient characteristics and programme participation rates were summarised using descriptive statistics. Continuous variables were presented using means with SD where values were normally distributed and the median and IQR otherwise. Categorical variables were summarised by frequencies with percentages. To compare outcomes between each of the time periods (baseline, 12 weeks and 6 months) changes in categorical variables were assessed by the McNemar test. Changes in continuous variables where the values were normally distributed were examined using the paired t-test and the Wilcoxon matched-pairs test was used where the changes in values between time points were not normally distributed. All comparisons were based on the same patients attending at both time frames. Statistical significance was set at p<0.05 and data were analysed using Stata (V.15.1).
Results
Programme uptake and retention rates
Between July 2020 and September 2020, 105 patients were referred to the programme, with 77 (74%) patients attending IA. Uptake and retention rates were high with 97% of patients (n=75) who attended the IA enrolling in the programme. Of these, 64 (85%) completed the programme, with a median attendance of 9/10 programme sessions. Programme completion was defined as attending 8 or more of the 10 programme sessions, inclusive of the EOP assessment. Of those who completed the programme (n=64), 55 (86%) attended the 6-month follow-up assessment.
Of the 28 individuals referred but who did not attend the IA, barriers to initial participation included poor digital literacy skills (n=4), limited access to the necessary IT infrastructure (ipad/laptop and internet connection) (n=4), illness (respiratory tract infections and COVID-19 (n=4), work commitments (n=3), preference for in person programme (n=3): for the remainder (n=10) either we were unable to contact them or they declined to provide a reason. Of the 11 individuals who enrolled in the programme but did not complete it, barriers to completion included lack of interest (n=4), poor home IT infrastructure (n=2), work commitments (n=3), moving overseas (n=1) and hearing difficulties (n=1).
Patient characteristics
Baseline characteristics of patients, including demographics, referral diagnosis and CVD risk factor profile, are outlined in table 1. The mean age of participants was 63 years, 81% were male, the majority were white (94%) and living with a family member (86%). At IA, patients presented with multiple poorly controlled risk factors (table 1), with 23% having had a previous cardiac event prior to the current referral diagnosis. There was a median wait time of 8 weeks from the event to referral, with patients being enrolled in the programme within 3 weeks on referral.
Table 1Baseline characteristics of patients referred to Croí MySláinte
| Patients (n=77) n (%) | ||
| Demographics | ||
| Age, years, median, IQR | 62.9±10.8 (35–84) | |
| Male | 62 (81%) | |
| Living with a family member | 66 (86%) | |
| Employed | 35 (45%) | |
| Unemployed | 5 (6%) | |
| Retired | 37 (48%) | |
| Living in a rural area | 43 (56%) | |
| Enrolled in GMS scheme | 28 (36%) | |
| Ethnicity—white Irish | 72 (94%) | |
| Referring diagnosis | ||
| Percutaneous coronary intervention | 37 (48%) | |
| Myocardial infarction and percutaneous coronary intervention | 24 (31%) | |
| Heart valve disease | 6 (8%) | |
| Coronary artery bypass graft | 5 (6%) | |
| Heart failure | 3 (4%) | |
| Myocardial infarction | 2 (3%) | |
| Risk factors | ||
| Physical activity | % NOT achieving targets (150 min/week) | 65 (84%) |
| Diet | % NOT achieving recommended Mediterranean Diet Score (optimal score ≥9) | 74 (96%) |
| Anthropometrics | % Overweight (BMI ≥25 kg/m2) | 37 (48%) |
| % Obese (BMI ≥30 kg/m2) | 21 (27%) | |
| Smoking | % Smokers | 2 (3%) |
| Psychosocial | % HADS anxiety score ≥8 | 26 (34%) |
| % HADS depression levels ≥8 | 14 (18%) | |
| Cholesterol | % NOT achieving recommended LDL targets (≤1.4 mmol/L) | 63 (82%) |
| Blood pressure | % NOT achieving recommended targets (≤130/80 mm Hg) | 57 (74%) |
BMI, body mass index; GMS, General Medical Services (refers to the means tested provision of state healthcare); HADS, Hospital Anxiety and Depression Scale; LDL, low-density lipoprotein.
Programme outcomes
Data relating to changes in lifestyle, psychosocial outcomes, medical risk factors and cardioprotective medications from IA to EOP and IA to 6-month follow-up are presented in tables 2 and 3. The proportion of patients achieving the ESC recommended guidelines for physical activity, blood pressure and low-density lipoprotein (LDL) cholesterol1 20 21 significantly increased from initial to EOP assessment, with changes being sustained at 6-month follow-up. With the exception of other (non-statin) lipid-lowering medications, there were no significant changes in the prevalence of participants prescribed cardioprotective medication although it is worth noting that the prescription of cardioprotective medication was already high at baseline. Nonetheless, the absolute proportion of patients on the maximum statin dose (eg, rosuvastatin 40 mg or atorvastatin 80 mg) increased 26% (95% CI 14% to 39%), from 19% at IA to 45% at EOP.
Table 2Changes (mean change or change in proportion followed by 95% CI) in lifestyle and psychosocial health in cardiovascular patients between IA, EOP and 6-month assessment
| From IA to EOP | From IA to 6-month follow-up | |||||||||
| n | IA | EOP | Change | P value | n | IA | 6 months | Change | P value | |
| Lifestyle | ||||||||||
| Mediterranean Diet Score mean (SD) | 63 | 5.2±2.1 | 7.3±2.2 | 2.1 (1.6, 2.6) | <0.001 | 55 | 5.3±2.1 | 7.3±2.1 | 2 (1.5, 2.7) | <0.001 |
| Weight (kg) mean (SD) | 61 | 86.3±17.5 | 83.7±16.1 | −2.6 (−3.5, –1.9) | <0.001 | 51 | 86.4±15.1 | 82.9±14.1 | −3.5 (−4.8, –2.4) | <0.001 |
| BMI (kg/m2) mean (SD) | 61 | 28.7±5.3 | 27.7±4.9 | −1.0 (−1.3, –0.7) | <0.001 | 51 | 28.6±4.5 | 27.5±4.2 | −1.1 (−1.6, 0.8) | <0.001 |
| Physical activity (≥150 min per week) % | 52 | 14 | 82 | 68 (52, 84) | <0.001 | 53 | 15 | 64 | 49 (32, 66) | <0.001 |
| Estimated MET max | 52 | 7.9±2.2 | 10±1.9 | 2.1 (1.6, 2.6) | <0.001 | – | – | – | – | – |
| Smoking (%) | 64 | 2 | 0 | −2 (−6, 3) | 1.00 | – | – | – | – | – |
| Pyschosocial Health | ||||||||||
| HADS anxiety median (IQR) | 60 | 6 (3, 10) | 4 (1, 6) | −2 (−3, –1) | <0.001 | 34 | 6 (3, 9) | 4 (1, 8) | −2 (−3, –1) | <0.001 |
| HADS anxiety >8 (%) | 60 | 40 | 17 | −23 (−9,38) | 0.001 | 34 | 41 | 26 | −15 (−3,32) | 0.13 |
| HADS depression median (IQR) | 60 | 3 (1, 6) | 2 (0, 4) | −1 (−2, 0) | <0.001 | 34 | 3 (1, 6) | 1 (0, 4) | −2 (−2, 0) | <0.001 |
| HADS depression >8 (%) | 60 | 22 | 10 | −12 (−2, 21) | 0.02 | 34 | 18 | 14 | −4 (−10, 16) | <0.001 |
| EQ-VAS mean (SD) | 60 | 70±15 | 85±9 | 15 (12, 19) | <0.001 | 34 | 70±15 | 80±10 | 10 (5, 15) | <0.001 |
| EQ-5D-5L median (IQR) | 27 | 1.00 (0.67, 1.00) | 1.00 (0.77, 1.00) | 0.00 (0.00, 0.01) | 0.003 | 17 | 1.00 (0.61, 1.00) | 1.00 (0.85, 1.00) | 0.00 (−0.2, 0.11) | 0.61 |
–, data unavailable; BMI, body mass index; EOP, end of programme; EQ-5d-5L, EuroQOL 5 Dimension 5 Level; HADS, Hospital Anxiety and Depression Scale; IA, initial assessment; MET, metabolic equivalent; VAS, Visual Analogue Scale.
Table 3Changes (mean change or change in proportion followed by 95% CI) in medical risk factors and cardioprotective medications in cardiovascular patients between IA, EOP and 6-month assessment
| From IA to EOP | From IA to 6 month follow-up | |||||||||
| n | IA | EOP | Change | P value | n | IA | 6 months | Change | P value | |
| Blood pressure (mm Hg) | ||||||||||
| Systolic blood pressure mean(SD) | 62 | 137.1±15.7 | 117.6±8.1 | −19.5 (−23.2, –15.8) | <0.001 | 54 | 137.3±15.9 | 119.9±11.5 | −17.7 (−22.5, –12.5) | <0.001 |
| Diastolic blood pressure mean (SD) | 62 | 75.9±9.3 | 73.7±8.3 | −2.2 (−5.2, 0.9) | 0.17 | 54 | 75.4±9.0 | 74.9±7.9 | −0.5 (−3.5, 2.5) | 0.76 |
| Blood pressure <130/80 (%) | 62 | 24 | 68 | 44 (27, 60) | <0.001 | 54 | 26 | 69 | 43 (25, 59) | <0.001 |
| LDL cholesterol | ||||||||||
| LDL (mmol/l) mean (SD) | 59 | 2.33±0.88 | 1.57±0.58 | −0.76 (−0.98, –0.54) | <0.001 | 37 | 2.18±0.76 | 1.71±0.74 | 0.47(−0.77, –0.16) | 0.004 |
| LDL <1.4 mmol/L (%) | 59 | 14 | 41 | 27 (14, 40) | <0.001 | 37 | 14 | 41 | 27 (5, 49) | 0.02 |
| HbA1c <53* (%) | 4 | 50 | 50 | 0 (−25, 25) | 1.00 | 3 | 67 | 67 | 0 (−33, 33) | 1.00 |
| Cardioprotective medications | ||||||||||
| Antiplatelets (%) | 64 | 91 | 91 | 0 (−2, 2) | 1.00 | 55 | 89 | 89 | 0 (−2, 2) | 1.00 |
| Beta blockers (%) | 64 | 67 | 66 | −1 (−6, 3) | 1.00 | 55 | 66 | 62 | −4 (−10, 30) | 0.50 |
| ACE inhibitors (%) | 64 | 36 | 36 | 0 (−9, 9) | 1.00 | 55 | 35 | 35 | 0 (−9, 9) | 1.00 |
| ARB’s (%) | 64 | 22 | 25 | 3 (−3, 9) | 0.5 | 55 | 25 | 31 | 6 (−2, 13) | 0.25 |
| Calcium channel blockers (%) | 64 | 19 | 22 | 3 (−3, 9) | 0.5 | 55 | 18 | 24 | 6 (−2, 2) | 0.25 |
| Statins (%) | 64 | 84 | 88 | 2 (−5, 11) | 0.63 | 55 | 82 | 82 | 0 (−11, 11) | 1.00 |
| Other lipid lowering medications (%) | 64 | 5 | 17 | 12 (3, 22) | 0.008 | 55 | 5 | 22 | 17 (5, 28) | 0.004 |
*In those with known diabetes.
ARBs, angiotensin II receptor blockers; EOP, end of programme; HbA1c, glycosylated haemoglobin; IA, initial assessment; LDL, low-density lipoprotein.
Significant reductions to weight and BMI were observed and these were maintained at 6 months, with 33% of patients achieving a weight loss of ≥5%. Anxiety and depression levels more than halved between baseline and EOP assessment, with significant improvements in patient-reported outcomes as indicated by the EQ-VAS and EQ-5D-5L. With the exception of the EQ-5D-5L, these improvements were sustained at 6 months.
Only one adverse event was reported during the supervised exercise sessions and this was non-cardiac in nature.
Discussion
International guidelines and position papers recommend that measurement of outcomes at the EOP should be a core component of modern CR programmes.18 19 However, this has been particularly challenging to achieve during the COVID-19 pandemic. To our knowledge, this is one of the first studies to report both short and longer-term clinical, lifestyle and psychosocial outcomes from a digital CR programme delivered during the pandemic. Consistent with recent systematic reviews,10 11 our study shows that it is feasible to deliver comprehensive CR remotely and achieve the recommended lifestyle, medical and therapeutic targets that are known to be associated with reduced CVD events and improved health outcomes.1
Furthermore, while acknowledging the small sample size and different patient cohorts, the findings of the Croí MySláinte digital CR programme compare favourably to published outcomes for the in-person MyAction programme previously delivered in Galway (Ireland) and in Westminster (UK).16 24 For example, at MySláinte EOP, the proportions achieving the recommended targets for LDL increased by 27% (14% at IA to 41%at EOP), versus 6.3% (48.2% at IA to 54.5% at EOP) and 23.8% (25.2% at IA to 49% at EOP) for the Westminster and Galway programmes, respectively. Similarly, EOP proportions achieving the recommended targets for blood pressure in MySláinte increased by 44% (24% at IA–68% at EOP), versus 15.3% (70.3% at IA to 85.6% at EOP) and 25.3% (51.6% at IA to 76.9% at EOP) for the Westminster and Galway programmes, respectively. For physical activity, mean functional capacity increased by 2.1 (7.9 at IA to 10 at EOP) MET maximum in comparison to 0.9 (7.6 at IA to 8.5 at EOP) on the Westminster and 1.7 (7.5 at IA to 9.2 at EOP) on the Galway programme. Furthermore, the reductions in anxiety and depression levels (HADS ≥8) of 23% (40% at IA to 17% at EOP) and 12% (22% at IA to 10% at EOP) compared favourably with those achieved on the Westminster programme of 1.55% (27.8% at IA to 26.3% at EOP) and 11.6% (23.2% at IA to 11.6% at EOP) and the Galway programme of 12.1% (32.5% at IA to 20.4% at EOP) and 10.9% (18.2% at IA to 7.3% at EOP). 16 24
These findings may be due to Croí MySláinte’s increased emphasis on self-management and the provision of tools such as home blood pressure monitors and Fitbit wearables. Self-management DHIs have been shown to be an effective treatment for the management of hypertension, with two recent systematic reviews reporting improved systolic and diastolic control and medication adherence in comparison to the control groups.25 26 Furthermore, the meta analysis results of 17 randomised controlled trials (RCTs) in a systematic review by Kirk et al showed wearable devices significantly increased both steps and moderate to vigorous physical activity in CVD patients.27
Furthermore, in contrast to the in person MyAction programme, the prescribing and optimisation of cardioprotective medication in MySláinte was initiated by a nurse prescriber, with cardiologist, GP and pharmacist support. This helped ensure efficient guideline-driven management of lipids and blood pressure at a time when access to general practice and hospital-based cardiology support was limited. While there were modest improvements in the use of most cardioprotective medications, these were not significant, the exception being increased prescribing of other lipid lowering agents and up titration of statin doses. It is likely that the significant reductions to blood pressure and LDL cholesterol were due to a combination of increased prescribing, dose-changes, support with medication adherence and lifestyle modification. Consistent with Cochrane systematic review evidence,28 findings from this study highlight the important role of non-medical prescribing by nurses and wider implementation of this practice in CR DHIs, should be considered.
In keeping with findings by Candelaria et al and Huang et al,29 30 our study showed that CR DHIs can significantly improve health related quality of life and anxiety and depression at EOP, with the majority of these changes being sustained at 6-month follow-up. These improvements can be attributed to the strong emphasis placed on addressing psychosocial health through group-based activities, stress management and psychological support. The timing of this support was particularly important given the reported increase in pandemic related psychological distress, including social isolation among patients with CVD.31 Furthermore, it is well established that a healthy diet and regular physical activity can positively impact on quality of life and symptoms of anxiety and depression.1
A key feature of our programme was the delivery of a remote programme of supervised exercise training. Recent survey data highlighted that only 25.5% of CR centres globally provided supervised exercise training in the first few months of the pandemic.6 We achieved this through individualised risk assessment, supported by functional capacity testing using the sub maximal Chester Step Test, and monitoring through Fitbit and live video conferencing.
Multiple studies have demonstrated that effective diet and weight management interventions can be delivered using DHIs.32 We observed significant improvements in self-reported adherence to the Mediterranean diet (+2.1 units, p<0.001) and reductions in BMI (−1.0, p<0.001) and weight (−2.6 kg, p<0.001), which were sustained at 6-month follow-up.
Programme participation
The high programme uptake and retention rates are consistent with existing evidence which shows that adherence to DHIs is not inferior to in person CR programmes.10 It is likely that the support and training provided to patients in the use of the programme technology helped enable access and increase participation. Of note, we observed that 56% of programme participants (n=43) were living in rural areas, suggesting that the convenience of less travel may have been an important factor in influencing attendance. Despite waiting on average 8 weeks for referral to CR, once referred, patients received access to Croí MySláinte within 3 weeks. The need for timely CR is well established, with guidelines recommending that CR should start as early as possible after a cardiac event.1 33 However, in reality global access and uptake of CR remains consistently poor,2 with a recent Irish survey reporting that 40% of patients are waiting at least 3 months for CR.34 This highlights the potential role that digital CR programmes such as Croí MySláinte could play in broadening CR access, minimising waiting times and ensuring consistent delivery of services beyond the pandemic.
Delivering the core components
Notwithstanding the rapid implementation of Croí MySláinte, a key strength of the programme was its focus on delivering the internationally recommended core components (medical and lifestyle risk factor management, health behaviour change, psychosocial health and cardioprotective medications), which are necessary to achieve optimal CR benefits.18 19 It is highly likely that the inclusion of these components contributed to the significant clinical outcomes achieved on Croí MySláinte. In contrast, there is significant heterogeneity in the delivery of the core components in CR DHIs with a recent systematic review by Wongvibulsin et al highlighting that from 31 selected studies of DHIs only 6 included 5 or more of the recommended CR components with risk factors such as smoking cessation, lipid management and blood glucose levels being poorly addressed.10 While there have been increasing calls by organisations such as the EAPC to maintain the delivery of the core components during the pandemic, this proved difficult for many centres, where limiting the provision of elements such as supervised exercise training and initial and EOP assessments was essential to retain some level of service.6 32 35 The successful delivery of the core components on Croí MySláinte can be attributed to the skilled interdisciplinary team of healthcare professionals, who together with the technologies employed helped to ensure that a tailored programme of care that aligned to the patients’ needs and risk factor profile was offered.
Limitations
There are a number of limitations to our study. First, cause and effect cannot be inferred due to the observational nature of the study design. For example, CVD risk factors may have been improving in the patients enrolled as a function of their usual care and not due to the intervention. As such, future research should ideally include a comparison group preferably based in the same centre. However, it is reassuring that our virtual Croí MySláinte intervention is almost identical to the in-person intervention delivered during the EuroAction trial (this trial did have a comparison group and did demonstrate superior efficacy for the intervention relative to control)17 Second, despite participants being recruited from five hospital sites in Ireland, the generalisability of our findings may be limited, as these sites were located in one region of Ireland. Nonetheless, the results are comparable to those achieved in international face-to-face programmes on which Croí MySláinte is modelled. Third, there was the potential for selection bias as patients who were more motivated and engaged in their health may have been more likely to participate, however the suboptimal control of risk factors at baseline could suggest otherwise (table 1). Furthermore, as patients were required to have an internet connection and access to either an iPad/laptop this potentially excluded those with low digital health literacy. For DHIs to reach their full potential, consideration must be given to health literacy and ensuring equitable access to technologies. Moreover, to understand the potential inequalities associated with DHIs, future research needs to be more inclusive of marginalised populations such as ethnic minorities and socioeconomic deprived groups and, where possible, sources of inequalities should be reported so that effective strategies can be developed to address them. Fourth, as this study was conducted during two National lockdowns, the imposed restrictions impacted on the ability to collect outcome data in a standardised way for all participants, for example, CR centres may have used different equipment such as weighing scales and bloods may have been sent to different laboratories for analysis. In addition, many participants found it difficult to secure appointments with their GPs for bloods; this resulted in incomplete data for some risk factors. Finally, while the focus of this study was on evaluating service and patient outcomes, there is also a need to explore the patient and healthcare professional’s perspectives of DHIs. This will help inform future development of digital CR programmes and the systems required to support implementation and scalability. To address this the authors are conducting qualitative research in this area.
Conclusion
Outcomes from Croí MySláinte provide important ‘proof of concept’ that guideline based, multicomponent digital CR programmes can be successfully implemented and achieve measurable improvements in medical and lifestyle risk factors and psychosocial health. Given the pre-COVID-19 care gaps, such as poor uptake and accessibility of hospital/centre-based CR programmes, there is an urgent need to offer all eligible patients a choice of CR delivery options that meet with their needs and preferences. While DHIs are one such option, they should not be viewed as a one-size-fits-all solution and, where barriers to DHI participation exist, patients should continue to be offered centre-based programmes. Importantly, these interventions must ensure quality in both the reporting of their intervention and in service delivery, specifically incorporating the evidence-based core components of comprehensive CR. With COVID-19 likely to result in disruption to health services for the foreseeable future, it would seem timely to embrace digital health and use the skills and infrastructure that have been developed during the pandemic to optimise the future delivery of guideline-based CR.
The authors wish to thank: the staff at the programme referral centres, which included the cardiology and rehabilitation departments at Galway, Mayo and Sligo University Hospitals, the Galway Clinic and Bon Secours Hospital, Galway; Croí MySláinte programme participants; Maureen Boyle and Dr. Jenni Jones at the National Institute of Prevention and CVD Health; Annie Costelloe, Bridget Cheasty, Caroline Costello, Lizanne Dunleavy, Edel Kennelley and Neil Johnson at Croí, the West of Ireland Cardiac and Stroke Foundation; Paul Bassett, Statsconsultancy, UK; Dr. Susan Connolly,
Integrated Care, University Hospital Galway and CHO2 West;
Prof. Lis Neubeck at Edinburgh Napier University, Scotland; the Government of Ireland and the Pobal Sláintecare team.
Data availability statement
Data are available on reasonable request.
Ethics statements
Patient consent for publication
Not applicable.
Ethics approval
The study was approved by the Galway Clinical Research Ethics Committee (Ref. C.A. 2689). Participants gave informed consent to participate in the study before taking part.
Twitter @Ir_Gibson, @zoej121
Contributors The first author of this paper, IG, devised the study idea, assisted in the development and delivery of the study intervention, the analysis plan, the analysis and drafted the manuscript. EM, MB and AWM revised the manuscript for important intellectual content. LH, ZM and DD and AH assisted in the development and delivery of the study intervention, assisted with data collection and data interpretation. JWM devised the study idea, assisted in the development of the study intervention, provided study oversight, support with analysis, mentorship and extensive revisions for intellectual content. JWM acts as the guarantor for this study.
Funding Croí MySláinte was funded by the Government of Irelands Sláintecare Integration Fund 2019, under Grant Agreement number 121. This research study was supported by the Health Research Board, Collaborative Doctoral Programme in Chronic Disease Prevention.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.
1 Visseren FLJ, Mach F, Smulders YM, et al. 2021 ESC guidelines on cardiovascular disease prevention in clinical practice. Eur Heart J 2021; 42: 3227–337. doi:10.1093/eurheartj/ehab484
2 Taylor RS, Dalal HM, McDonagh STJ. The role of cardiac rehabilitation in improving cardiovascular outcomes. Nat Rev Cardiol 2022; 19: 180–94. doi:10.1038/s41569-021-00611-7
3 Kotseva K, De Backer G, De Bacquer D, et al. Lifestyle and impact on cardiovascular risk factor control in coronary patients across 27 countries: results from the european society of cardiology ESC-EORP EUROASPIRE V registry. Eur J Prev Cardiol 2019; 26: 824–35. doi:10.1177/2047487318825350
4 Curneen JM, Judge C, Traynor B, et al. Interhospital and interindividual variability in secondary prevention: a comparison of outpatients with a history of chronic coronary syndrome versus outpatients with a history of acute coronary syndrome (the iaspire study). Open Heart 2021; 8: e001659. doi:10.1136/openhrt-2021-001659
5 Santo K, Redfern J. Digital health innovations to improve cardiovascular disease care. Curr Atheroscler Rep 2020; 22: 71. doi:10.1007/s11883-020-00889-x
6 Ghisi GL de M, Xu Z, Liu X, et al. Impacts of the COVID-19 pandemic on cardiac rehabilitation delivery around the world. Glob Heart 2021; 16: 43. doi:10.5334/gh.939
7 Kuehn BM. Pandemic intensifies push for home-based cardiac rehabilitation options. Circulation 2020; 142: 1781–2. doi:10.1161/CIRCULATIONAHA.120.051769
8 The British Heart Foundation. The national audit of cardiac rehabilitation quality and outcomes report 2021. 2021. Available: www.bhf.org.uk/informationsupport/publications/statistics/national-audit-of-cardiac-rehabilitation-quality-and-outcomes-report-2021 [Accessed 1 Nov 2022 ].
9 World Health Organization. WHO guideline: recommendations on digital interventions for health system strengthening: evidence and recommendations. Contract no.: WHO/RHR/19.10. Geneva: World Health Organization, 2019.
10 Wongvibulsin S, Habeos EE, Huynh PP, et al. Digital health interventions for cardiac rehabilitation: systematic literature review. J Med Internet Res 2021; 23: e18773. doi:10.2196/18773
11 Anderson L, Sharp GA, Norton RJ, et al. Home-Based versus centre-based cardiac rehabilitation. Cochrane Database Syst Rev 2017; 6: CD007130. doi:10.1002/14651858.CD007130.pub4
12 Hoffmann TC, Glasziou PP, Boutron I, et al. Better reporting of interventions: template for intervention description and replication (tidier) checklist and guide. BMJ 2014; 348: g1687. doi:10.1136/bmj.g1687
13 von Elm E, Altman DG, Egger M, et al. The strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies. Ann Intern Med 2007; 147: 573–7. doi:10.7326/0003-4819-147-8-200710160-00010
14 Neubeck L, Hansen T, Jaarsma T, et al. Delivering healthcare remotely to cardiovascular patients during COVID-19: a rapid review of the evidence. Eur J Cardiovasc Nurs 2020; 19: 486–94. doi:10.1177/1474515120924530
15 Moulson N, Bewick D, Selway T, et al. Cardiac rehabilitation during the COVID-19 era: guidance on implementing virtual care. Can J Cardiol 2020; 36: 1317–21. doi:10.1016/j.cjca.2020.06.006
16 Gibson I, Flaherty G, Cormican S, et al. Translating guidelines to practice: findings from a multidisciplinary preventive cardiology programme in the West of Ireland. Eur J Prev Cardiol 2014; 21: 366–76. doi:10.1177/2047487313498831
17 Wood DA, Kotseva K, Connolly S, et al. Nurse-coordinated multidisciplinary, family-based cardiovascular disease prevention programme (EUROACTION) for patients with coronary heart disease and asymptomatic individuals at high risk of cardiovascular disease: a paired, cluster-randomised controlled trial. Lancet 2008; 371: 1999–2012. doi:10.1016/S0140-6736(08)60868-5
18 Ambrosetti M, Abreu A, Corrà U, et al. Secondary prevention through comprehensive cardiovascular rehabilitation: from knowledge to implementation. 2020 update. A position paper from the secondary prevention and rehabilitation section of the European association of preventive cardiology. Eur J Prev Cardiol 2020; 37: 2047487320913379. doi:10.1177/2047487320913379
19 Cowie A, Buckley J, Doherty P, et al. Standards and core components for cardiovascular disease prevention and rehabilitation. Heart 2019; 105: 510–5. doi:10.1136/heartjnl-2018-314206
20 Williams B, Mancia G, Spiering W, et al. 2018 ESC/ESH guidelines for the management of arterial hypertension. Eur Heart J 2018; 39: 3021–104. doi:10.1093/eurheartj/ehy339
21 Mach F, Baigent C, Catapano AL, et al. 2019 ESC/EAS guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. Eur Heart J 2020; 41: 111–88. doi:10.1093/eurheartj/ehz455
22 Piepoli MF, Hoes AW, Agewall S, et al. 2016 European guidelines on cardiovascular disease prevention in clinical practice: the sixth joint Task force of the European Society of cardiology and other societies on cardiovascular disease prevention in clinical practice (constituted by representatives of 10 societies and by invited experts) developed with the special contribution of the European association for cardiovascular prevention & rehabilitation (EACPR). Eur Heart J 2016; 37: 2315–81. doi:10.1093/eurheartj/ehw106
23 Sykes K, Roberts A. The chester step test—a simple yet effective tool for the prediction of aerobic capacity. Physiotherapy 2004; 90: 183–8. doi:10.1016/j.physio.2004.03.008
24 Connolly SB, Kotseva K, Jennings C, et al. Outcomes of an integrated community-based nurse-led cardiovascular disease prevention programme. Heart 2017; 103: 840–7. doi:10.1136/heartjnl-2016-310477
25 McLean G, Band R, Saunderson K, et al. Digital interventions to promote self-management in adults with hypertension systematic review and meta-analysis. J Hypertens 2016; 34: 600–12. doi:10.1097/HJH.0000000000000859
26 Li R, Liang N, Bu F, et al. The effectiveness of self-management of hypertension in adults using mobile health: systematic review and meta-analysis. JMIR Mhealth Uhealth 2020; 8: e17776. doi:10.2196/17776
27 Kirk MA, Amiri M, Pirbaglou M, et al. Wearable technology and physical activity behavior change in adults with chronic cardiometabolic disease: a systematic review and meta-analysis. Am J Health Promot 2019; 33: 778–91. doi:10.1177/0890117118816278
28 Weeks G, George J, Maclure K, et al. Non-medical prescribing versus medical prescribing for acute and chronic disease management in primary and secondary care. Cochrane Database Syst Rev 2016; 11: CD011227. doi:10.1002/14651858.CD011227.pub2
29 Candelaria D, Kirkness A, Farrell M, et al. Remote-delivered cardiac rehabilitation during COVID-19: a prospective cohort comparison of health-related quality of life outcomes and patient experiences. Eur J Cardiovasc Nurs 2022; 21: 732–40. doi:10.1093/eurjcn/zvac006
30 Huang K, Liu W, He D, et al. Telehealth interventions versus center-based cardiac rehabilitation of coronary artery disease: a systematic review and meta-analysis. Eur J Prev Cardiol 2015; 22: 959–71. doi:10.1177/2047487314561168
31 Khera A, Baum SJ, Gluckman TJ, et al. Continuity of care and outpatient management for patients with and at high risk for cardiovascular disease during the COVID-19 pandemic: a scientific statement from the American society for preventive cardiology. Am J Prev Cardiol 2020; 1: 100009. doi:10.1016/j.ajpc.2020.100009
32 Scherrenberg M, Wilhelm M, Hansen D, et al. The future is now: a call for action for cardiac telerehabilitation in the COVID-19 pandemic from the secondary prevention and rehabilitation section of the European association of preventive cardiology. Eur J Prev Cardiol 2020; 2020: 2047487320939671. doi:10.1177/2047487320939671
33 Fell J, Dale V, Doherty P. Does the timing of cardiac rehabilitation impact fitness outcomes? an observational analysis. Open Heart 2016; 3: e000369. doi:10.1136/openhrt-2015-000369
34 Irish Heart Foundation and Irish Association for Cardiac Rehabilitation. Lifesaving cardiac rehabilitation service in crisis [press release]. 2021.
35 O’Doherty AF, Humphreys H, Dawkes S, et al. How has technology been used to deliver cardiac rehabilitation during the COVID-19 pandemic? an international cross-sectional survey of healthcare professionals conducted by the BACPR. BMJ Open 2021; 11: e046051. doi:10.1136/bmjopen-2020-046051
© 2023 Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.
Details
; McCrudden, Zoe 2 ; Dunne, Denise 3 ; Harris, Aisling 4 ; Hynes, Lisa 4 ; Murphy, Ella 5 ; Murphy, Andrew William 6 ; Byrne, Molly 7 ; McEvoy, John William 1 1 School of Medicine, University of Galway, Galway, Ireland; National Institute for Prevention and Cardiovascular Health, Galway, Ireland
2 Sligo University Hospital, Sligo, Ireland
3 Community Healthcare West, Health Service Executive West, Galway, Ireland
4 Croí, West of Ireland Cardiac and Stroke Foundation, Galway, Ireland
5 School of Medicine, University of Galway, Galway, Ireland
6 Discipline of General Practice, University of Galway, Galway, Ireland
7 Health Behaviour Change Research Group, University of Galway, Galway, Ireland