Correspondence to Buna Bhandari; [email protected]
Strengths and limitations of this study
This study uses short message service text messages which are affordable in Nepal, a low-income country, to overcome systemic constraints to improve the management of hypertension.
The intervention has been developed using a formative qualitative research model guided by an accepted capability, opportunity, motivation, behaviour theoretical framework for behavioural change.
The study will be novel in terms of the use of mobile technology for chronic disease management in Nepal.
This feasibility study will be conducted in one hospital in Nepal, which limits its generalisability.
The intervention does not allow blinding of participants and assessors of the outcome.
Introduction
An estimated 26% of the world’s population have hypertension (HTN).1 This figure is expected to increase to 29% by 2025, primarily driven by increases in low-income and middle-income countries (LMICs).1 2 HTN is the highest risk factor for cardiovascular disease, of which ischaemic heart disease (IHD) and stroke are the first and fifth leading causes of death worldwide.3 In Asia, the prevalence of HTN ranges from 15% to 35%.4 Nepal, a low-income country in South Asia, has an estimated prevalence of HTN of 27.3%.5 The study on burden of disease of Nepal in 2017 reported non-communicable diseases, such as HTN, is the leading cause of death (66%) where IHD is a significant contributor of death (16.4% of total death) and the highest cause of disability-adjusted life-years (7.6%) in Nepal.6
Despite available information for the effective treatment of HTN, more than half of diagnosed hypertensive patients have uncontrolled blood pressure in LMICs.7 8 Low levels of adherence to antihypertensive medication have been reported as the main factor contributing to poor blood pressure control.9 Though effective medications for blood pressure control are available, adherence to long-term therapies is low, and this is worse in developing countries and among lower socioeconomic groups.10 In Nepal, controlled blood pressure among hypertensive patients varies by geographical region and ranges from 35%11 to 49%12 in the Central Development Region and only 15% in the Western Development Region of Nepal.13 Studies in Nepal have shown that self-reported adherence to antihypertensive medication varies from 35.4% to 64.3%,14–16 leading to many complications.
Along with adherence to medication, lifestyle modifications such as lowering salt intake and increasing physical activity are essential for blood pressure control.17 A meta-analysis of studies of HTN and its management by Baena et al18 found that lifestyle interventions could significantly lower BP levels in LMICs. Barriers to lifestyle change have been identified in previous studies of Nepal12 19 and our formative qualitative study.20 Therefore, there is a need for acceptable and affordable solutions appropriate for LMICs to increase medication adherence21 and support lifestyle changes.18 In recent years, mHealth has emerged as an efficient strategy to reach wider audiences to effect behavioural change.22 Systematic reviews have shown the value of short message service (SMS) in promoting lifestyle change for chronic diseases, including HTN23 and in significantly increasing the medication adherence in chronic diseases.24
Globally, there are an estimated 6 billion cell phone users, and more than 6 trillion text messages are sent each year.25 Though a low-income country, the mobile phone penetration rate in Nepal is more than 90%. The use of mobile technology in the health system is limited to pilot projects by the government and some non-governmental organisations in Nepal.26 At this point in time, there are no robust scientific interventions using mobile technologies to manage chronic diseases in Nepal. This study aims to test the feasibility and acceptability of a text message intervention developed based on behavioural change theory to improve treatment adherence and lifestyle change among hypertensive patients in Nepal.
Aims and objectives
Primary objectives
To evaluate the feasibility and acceptability of a text message intervention providing support for medication adherence, lifestyle change, and blood pressure control delivered to hypertensive patients attending health facility in Nepal.
Secondary objectives
To test the feasibility of delivery of text messages and its acceptability using a validated measure.
To assess any differential recruitment and attrition rates across socioeconomic groups, gender and education.
To test the validity of translated measurement tools for medication adherence and self-efficacy for medication adherence.
To measure primary and secondary outcomes (mean blood pressure, medication adherence and salt intake) to allow estimation of the sample size for a definitive trial.
Methods and analysis
Standard Protocol Items Recommendations for Intervention Trials,27 Consolidated Standards of Reporting Trials (CONSORT) for a pilot feasibility study28 and Template for Intervention Description and Replication (TIDieR)29 guidelines have been used for this feasibility study.
Study design
This feasibility study employs a two-arm parallel-group, unblinded, individually randomised control trial design to test a mobile phone text messaging intervention for blood pressure control (TEXT4BP) compared with standard care for 3 months among hypertensive patients attending a tertiary hospital in Kathmandu, Nepal. This study will use a nested qualitative design to assess the acceptability the SMS intervention. CONSORT diagram for a feasibility trial28 has been used to illustrate the design of the study (figure 1).
Enlarge this image.Figure 1. Pilot and feasibility RCT CONSORT flow diagram of the TEXT4BP study. CONSORT, Consolidated Standards of Reporting Trials; RCT, randomised controlled trial; TEXT4BP, messaging intervention for blood pressure control.
Study populations
Participants’ eligibility criteria
Patients aged 18–69 years with a clinical diagnosis of HTN and currently receiving blood pressure-lowering medication for more than 3 months will be eligible. Participants need to have access to a mobile phone and be able to read a text message by themselves or with the help of family members. Participants need to be residing in the study area during the period of intervention to provide ease of contact.
Participants with current and past severe illness (myocardial infarction, stroke and kidney failure) which reduce their ability to participate in the study will be excluded. Patients with long-term disability due to mental illness, cognitive impairment or physical disability and women currently pregnant or in the postpartum period will also be excluded.
Study setting
This study is conducted in the cardiology and medicine outpatient department (OPD) at the Kathmandu Medical College and Teaching Hospital (KMCTH), Kathmandu, Nepal. In KMCTH, the Cardiology/Medicine OPD sees an average 15–20 adults daily for the care of HTN. In Nepal, treatment for HTN is not provided in all primary level healthcare facilities (Primary health care centers, Health posts), which was identified in the qualitative study. Therefore, a tertiary-level facility will be selected for the feasibility trial.
Recruitment of participants
All eligible hypertensive patients visiting in the cardiology/medical OPD of the KMCTH will be invited for participation in the study if they meet the eligibility criteria. Relevant health professionals (cardiologist, physician and nurses) will provide the information of the research and a study flyer describing the research to the interested eligible hypertensive patients. Those who are interested will be asked to contact the research team directly to register their interest to participate in the study. Once the interested participants initiate the contact, the researchers would describe the study, obtain written consent and carry out baseline data collection.
Intervention
The TIDieR29 guidelines have been used to describe the intervention (see online supplementary 1).
Intervention development
The development of the intervention followed a theory-based approach after eliciting barriers and facilitators for treatment and control of HTN among a similar population to the target group for the trial.20 Using a qualitative study of people with HTN, their family members and healthcare provider, barriers and facilitators to obtain and maintain treatment, a lifestyle change for low salt diet and physical activity were identified. Those barriers comprised of a lack of knowledge, misconceptions about disease and treatment, faith in other traditional medicines, irregularities in taking medications and beliefs about consequences, resistance to behavioural changes and stigma of the disease. Capability, opportunity, motivation, behaviour (COM-B) model and behavioural change techniques (BCTs) were used to categorise and map the findings under intervention functions of behaviour change wheel (BCW).30
The process used to identify and select content for text messages followed the guidance in Michie et al.31 We first mapped the identified barriers under the components of COM-B model in the BCW. Then we linked the identified barriers with the intervention functions of the BCW. To systematically address enablers and barriers, the content of the SMS intervention was developed using relevant BCTs32 and literature.33 The selection of BCTs was guided by the most frequently used list given by the Michie et al on linking intervention functions to BCTs31, and the principal investigator’s in-depth understanding of the context and analysis of the aforementioned qualitative study.20 We were limited in the selection of some BCTs (eg, goal setting) as the intervention was unidirectional and could not include feedback on behaviour. We did not provide some of the other types of BCTs (eg, incentivisation). Example of the link between barriers and facilitators, BCTs and text messages is given in online supplementary 2.
The text messages will be translated into Nepali language and pretested with participants similar to the target group to improve on content and face validity. This whole process of intervention development is depicted in figure 2.
Enlarge this image.Figure 2. Process of TEXT4BP intervention development. COM-B, capability, opportunity, motivation, behaviour; RCT, randomised controlled trial; SMS, short message service; TEXT4BP, messaging intervention for blood pressure control.
TEXT4BP intervention
Participants with HTN in the intervention group will receive mobile phone text messages in Nepali language containing information on HTN and its complications, taking medications, diet (low sodium, low fat) and physical activity (exercise), quitting/reduction of smoking and alcohol (tailored to the person for smoking and alcohol intake).
Intervention delivery
We would engage a recognised company (aakash SMS: https://aakashsms.com/) to deliver the text messages to our participants. The provider only requires a mobile phone number, and no sensitive personal information will be collected. The provider will use Nepal Telecom and NCell, the two largest mobile companies in the country to deliver the messages. Both companies are The Health Insurance Portability and Accountability Act (HIPAA) compliant and have stringent data security protocols in place to protect the privacy of their users.
Total number and frequency of text messages
Frequency of the text message was decided based on the response of the participants during the exploratory qualitative study. Text messages will be delivered three times a week for 3 months, a total of 36–40 text messages after enrolment in the study. The average length of the text message will be 160 characters.
Description of the standard care
The control group will be provided with the usual standard care. In Nepal, hypertensive patients usually receive a prescription of antihypertensive medicine and advise for follow-up as the standard care. At the end of the study (after 3 months), they will be provided pamphlets containing information about HTN and required behaviour modifications.
Study outcomes
Baseline measures
The baseline data collection tools contain questions on (1) sociodemographic factors, medical and family history (2) lifestyle factors: dietary salt consumption based on the WHO STEPS survey questionnaire,34 Hill-Bone compliance to High Blood Pressure Therapy scale,35 Medication Adherence Self-Efficacy scale36 and Knowledge and Perception of HTN questionnaire. Time points of measurement and follow-up measures are presented in table 1.
Table 1Study outcomes and time points of measurements
| Outcomes | Measures | 0 weeks | 12 weeks |
| Systolic blood pressure Diastolic blood pressure | Average of last of two measures of blood pressure. | √ | √ |
| Medication adherence Medication adherence self-efficacy | Hill-Bone compliance to high blood pressure therapy scale35 (14 items), Medication adherence self-efficacy scale36 (13 items) | √ | √ |
| Dietary habits (salt intake) Physical activity | Dietary salt (9 items)and physical activity(17 items)based on WHO stepwise approach to chronic disease surveillance scale.34 | √ | √ |
| Knowledge and perceptions of hypertension and its treatment | The structured questionnaire developed by the researchers (21 items) | √ | √ |
| Acceptability of the text message intervention* | The Marshfield usability survey tools,45 46(16 items) | √ |
*Feasibility and acceptability of intervention would only be assessed among intervention group participants.
Validity and reliability of the tools
All of the measures will be translated to Nepali following accepted standard procedures given by WHO37 by bilingual translators. Pilot testing of the translated tools to test face validity will be conducted. Factorial validity of the Hill-Bone Medication Compliance subscale and Medication Adherence Self-Efficacy scale will be carried out after baseline data collection. Composite reliability of scales will also be tested.
Physical measurement
Blood pressure, height, weight, waist and hip circumference will be measured by the researchers following standard guidelines. Blood pressure will be measured using the digital blood pressure monitor (Kenz BPM OS-30) following the 2018 European Society of Cardiology and European Society of Hypertension (ESC/ESH) guidelines38 for the office blood pressure measurement. Before taking the measurements, participants will be asked to sit comfortably and rest for 5 min with legs uncrossed. Three readings of the systolic and diastolic blood pressure will be measured 1–2 min apart. The average of the last two reading would be calculated. Bodyweight will be measured using digital scale and height will be measured using a stadiometer and waist, and hip circumference will be measured using a constant tension measuring tape (Tape finger finder measure—PE024).
Sample size
One objective of the feasibility study is to estimate the sample size for the definitive trial. The feasibility trial is not powered to test the effectiveness of the intervention; however, the sample size for the feasibility study was based on the recommendation for determining the sample size for pilot randomised controlled trial (RCT) studies.39 Whitehead et al,39 give recommendations for pilot studies followed by definitive RCTs. They recommended, to obtain the main trial designed with 90% power, two-sided 5% and standardised effect sizes that are extra small (0.1), a pilot trial with sample size per treatment arm of 75 is needed. We erred on the conservative side using the sample size of 75 and added a high attrition rate (of 30%) to obtain a sample size per arm of 100. We used a conservative estimate for attrition, based on a recent study.40 This is a parameter we would ascertain from this feasibility study to power the planned definitive study.
Randomisation, sequence generation and allocation concealment
Simple randomisation technique will be used for allocation.41 A random sequence of 200 numbers will be generated in two columns (100 each) using an open-source random number sequence generator (an online website Random.org). It will generate the random number in two columns (each 100) from 1 to 200. After the random number sequence is produced, the numbers indicating the group allocation (ie, one column numbers for the control group and two column numbers for the intervention group) will be placed in opaque sealed envelopes. The opaque envelops will be numbered on the outside according to the generated numbers and kept sequentially.42 The first author will generate a random number and prepare the envelopes. Then research assistant will assign the numbers to the respective participants after baseline data collection. Therefore, the investigator could not foresee which group each participant would be allocated to until the commencement of the baseline measurement and reduce the allocation bias. There is a risk of manipulation while using this method. Several steps will be taken to reduce this. First, we will use adequately numbered opaque sealed envelopes to maintain allocation concealment. The sealed envelopes will be stored in a safe and secure place in the office with only the principal investigator having access to the keys. In addition, the principal investigator will supervise the process to ensure that envelopes are numbered in advance, opened sequentially and only after the baseline data has been collected, and participants’ details are written on the appropriate envelope. The method of sealed envelopes is one of the methods suggested by Schulz and Grimes43 for the allocation concealment to prevent selection bias.
The probability of unequal group sizes using this method of randomisation diminishes with large sample sizes (of 200 and over).44 Any significant imbalance in baseline characteristics between the groups will be tested and adjustments made during the outcome analysis.
Data collection procedures
Baseline data collection
Baseline data collection will be carried out using a structured computerised survey tool (Kobo toolbox) with in-built logic checks and skip patterns to minimise data entry error in the password-protected electronic device of the researcher. Measurements are listed in table 1. Details of physical measures are given above.
Follow up data collection
Follow-up data collection will be conducted 3 months following enrolment in the study and will follow the same procedures as at baseline. Participants in the intervention group will be asked questions on the acceptability of the text message intervention using modified Marshfield usability survey tools.45 46 In-depth interview with intervention group (5-6) participants will be conducted to explore their perceptions and experiences of mobile phone text message interventions.
Retention of the study participants
To improve compliance and retention, participants will receive at least three phone calls to remind them of follow-up. If the researchers are unable to locate the participants after these attempts, then no further calls will be made, and they will be recorded as lost to follow-up. Participants will be provided with a small incentive (Nepalese Rupees 100, equivalent to AUD 1.28) during the follow-up visits as reimbursement for transportation costs.
Data management and analysis methods
At the first stage of analysis, we will compare the baseline characteristics of study participants in the study intervention group and follow-up status. Preliminary indicative estimates of differences in primary and secondary outcomes by the group will be obtained. We will power the future c-RCT predominantly based on magnitudes of effect that are of public health relevance rather than using magnitudes of effects obtained from the study.
Differential recruitment and attrition rates across socioeconomic groups, age, education and gender, will be analysed using a X2 test and report on any associations with attrition rates. These data will be used to support the required sample size estimates for the definitive trial.
Feasibility and acceptability of the intervention will be assessed by the level of completeness and by follow-up qualitative interviews with a subsample of the intervention group participants. The acceptability of the text message intervention using Marshfield usability scale questions45 46 would be assessed based on the age, gender and education using chi-square test. Qualitative interviews will be transcribed, and line-by-line coding will be conducted to generate the codes. Descriptive thematic analysis will be carried out using NVivo software V.12 (QSR International, London, UK and USA).
Patient and public involvement
This research is planned to conduct without patient or public involvement. Though, the intervention development was done with the input from respondents, key informants and healthcare workers in the formative research, participants were not invited to comment on the study design or to contribute to the writing of this manuscript.
Ethics and dissemination
A data monitoring board would be formed comprising three members (one from the representative of NHRC and two subject experts). The study will be conducted according to the protocol, and any deviations will be formally notified. Adverse events will be recorded in adverse events reporting form developed according to the guidelines provided by the University Human Research Ethics Committee.
Due to the nature of the non-clinical intervention, receipt of text messages does not pose any additional risks. Previous studies have not reported any adverse effects. We do not foresee any adverse effects due to non-clinical nature of the intervention. The result of this study will be published in scientific peer-reviewed journals and presented in scientific conferences. The research report will be disseminated to the related authority of the Ministry of Health and Population of Nepal for informing policy. The anonymity of the participants will be maintained by using deidentified information of participants.
Discussion and conclusion
This TEXT4BP study aims to assess the feasibility and acceptability of mobile phone text message intervention for improving treatment adherence and lifestyle modifications among hypertensive patients in Nepal. While the use of SMS text messaging as an effective intervention has been reported in other countries,23 24 it has not been tested in Nepal and this will be a first study in Nepal. Hence, the study could provide evidence of the feasibility and value of alternative solutions like mobile technology in contexts with high rates of uncontrolled blood pressure and poor public healthcare resourcing.
The feasibility TEXT4BP RCT study has many strengths. The intervention has been developed using robust methods by conducting formative qualitative research guided by the theoretical framework. The text messages were developed based on the needs identified linking with BCTs. The feasibility study will be conducted in one hospital and does not represent wider population in the country. The role of the feasibility trial is to test operational fidelity in a diverse group representing a broader sociodemographic and geographical location. Adherence to antihypertensive medication will be assessed using self-reported measure as more objective measures are not practicable in the setting. However, the standardised tool having a high rate of reliability and tested and developed specifically for the hypertensive patients would be used to reduce self-reported bias. Given the major workforce constraints in delivering services for chronic disease in LMICs the use of alternative strategies to reach and motivate patients with cardiovascular disease is an important strategy. The study will lead to a definitive trial to find evidence of the effectiveness of such interventions.
BB is the recipient of an Australia Awards Scholarship to PhD provided by the Department of Foreign Affairs and Trade Australia, without which this study would not have been planned.
Twitter @bunabh, @padmanesan
Contributors All authors contributed to the preparation of research design, data management and data interpretation. BB wrote the first version of this manuscript. All the authors BB, RJ, PN and AV were involved in the revision and finalisation of the manuscript. All authors read and approved the final version of the manuscript.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
1 Kearney PM, Whelton M, Reynolds K, et al. Global burden of hypertension: analysis of worldwide data. Lancet 2005; 365: 217–23. doi:10.1016/S0140-6736(05)17741-1 http://www.ncbi.nlm.nih.gov/pubmed/15652604
2 Mills KT, Bundy JD, Kelly TN, et al. Global disparities of hypertension prevalence and control: a systematic analysis of population-based studies from 90 countries. Circulation 2016; 134: 441–50. doi:10.1161/CIRCULATIONAHA.115.018912 http://www.ncbi.nlm.nih.gov/pubmed/27502908
3 GBD 2017 Risk Factor Collaborators. Global, regional, and national comparative risk assessment of 84 behavioural, environmental and occupational, and metabolic risks or clusters of risks for 195 countries and territories, 1990-2017: a systematic analysis for the global burden of disease study 2017. Lancet 2018; 392: 1923–94. doi:10.1016/S0140-6736(18)32225-6 http://www.ncbi.nlm.nih.gov/pubmed/30496105
4 Singh RB, Suh IL, Singh VP, et al. Hypertension and stroke in Asia: prevalence, control and strategies in developing countries for prevention. J Hum Hypertens 2000; 14: 749–63. doi:10.1038/sj.jhh.1001057 http://www.ncbi.nlm.nih.gov/pubmed/11095165
5 Huang Y, Guo P, Karmacharya BM, et al. Prevalence of hypertension and prehypertension in Nepal: a systematic review and meta-analysis. Glob Health Res Policy 2019; 4: 11. doi:10.1186/s41256-019-0102-6 http://www.ncbi.nlm.nih.gov/pubmed/31165100
6 NHRC, MoHP, MEOR. Burden of disease 2017: a country report based on the global burden of disease 2017 study. Kathmandu, Nepal. Nepal health research Council (NHRC), Ministry of health and population (MoHP) and monitoring evaluation and operational research (MEOR. Nepal, 2019.
7 Chow CK, Teo KK, Rangarajan S, et al. Prevalence, awareness, treatment, and control of hypertension in rural and urban communities in high-, middle-, and low-income countries. JAMA 2013; 310: 959–68. doi:10.1001/jama.2013.184182 http://www.ncbi.nlm.nih.gov/pubmed/24002282
8 Lloyd-Sherlock P, Beard J, Minicuci N, et al. Hypertension among older adults in low- and middle-income countries: prevalence, awareness and control. Int J Epidemiol 2014; 43: 116–28. doi:10.1093/ije/dyt215 http://www.ncbi.nlm.nih.gov/pubmed/24505082
9 Burnier M. Medication adherence and persistence as the cornerstone of effective antihypertensive therapy. Am J Hypertens 2006; 19: 1190–6. doi:10.1016/j.amjhyper.2006.04.006
10 Bowry ADK, Shrank WH, Lee JL, et al. A systematic review of adherence to cardiovascular medications in resource-limited settings. J Gen Intern Med 2011; 26: 1479–91. doi:10.1007/s11606-011-1825-3 http://www.ncbi.nlm.nih.gov/pubmed/21858602
11 Karmacharya BM, Koju RP, LoGerfo JP, et al. Awareness, treatment and control of hypertension in Nepal: findings from the Dhulikhel heart study. Heart Asia 2017; 9: 1–8. doi:10.1136/heartasia-2016-010766 http://www.ncbi.nlm.nih.gov/pubmed/28123454
12 Devkota S, Dhungana RR, Pandey AR, et al. Barriers to treatment and control of hypertension among hypertensive participants: a community-based cross-sectional mixed method study in municipalities of Kathmandu, Nepal. Front Cardiovasc Med 2016; 3: 26. doi:10.3389/fcvm.2016.00026 http://www.ncbi.nlm.nih.gov/pubmed/27532038
13 Neupane D, Shrestha A, Mishra SR, et al. Awareness, prevalence, treatment, and control of hypertension in Western Nepal. Am J Hypertens 2017; 30: 907–13. doi:10.1093/ajh/hpx074 http://www.ncbi.nlm.nih.gov/pubmed/28531244
14 Muhammad Khan G, Kumar Thapa R, Khakurel A, et al. Medication adherence and blood pressure control among hypertensive patients of Pokhara Valley. Jhas 2013; 3: 64–7. doi:10.37107/jhas.59
15 Bhandari DR, Upadhya N, Tamrakar BK. A study on drug therapy and treatment adherence of hypertensive patients in an urban setting of Nepal. The Journal of Medicine Use in Developing Countries 2009; 1: 20–34.
16 Bhandari B, Bhattarai M, Bhandari M, et al. Adherence to antihypertensive medications: population based follow up in eastern Nepal. J Nepal Health Res Counc 2015; 13: 38–42. http://www.ncbi.nlm.nih.gov/pubmed/26411711
17 Bruno CM, Amaradio MD, Pricoco G, et al. Lifestyle and hypertension: an evidence-based review. J Hypertens Manag 2018; 4: 1–10.
18 Baena CP, Olandoski M, Younge JO, et al. Effects of lifestyle-related interventions on blood pressure in low and middle-income countries: systematic review and meta-analysis. J Hypertens 2014; 32: 961–73. doi:10.1097/HJH.0000000000000136 http://www.ncbi.nlm.nih.gov/pubmed/24577409
19 Shrestha S, Shrestha A, Koju RP, et al. Barriers and facilitators to treatment among patients with newly diagnosed hypertension in Nepal. Heart Asia 2018; 10: e011047. doi:10.1136/heartasia-2018-011047 http://www.ncbi.nlm.nih.gov/pubmed/30233660
20 Bhandari B, Narasimhan P, Vaidya A, et al. Barriers and facilitators for treatment and control of high blood pressure among hypertensive patients in Kathmandu, Nepal: a theory-driven qualitative study (submitted). BMC Public Health 2020.
21 Nieuwlaat R, Wilczynski N, Navarro T, et al. Interventions for enhancing medication adherence. Cochrane Database Syst Rev 2014; 11: CD000011. doi:10.1002/14651858.CD000011.pub4 http://www.ncbi.nlm.nih.gov/pubmed/25412402
22 WHO. mHealth: new horizons for health through mobile technologies. global Observatory for eHealth series, 2011: 3.
23 Vargas G, Cajita MI, Whitehouse E, et al. Use of short messaging service for hypertension management: a systematic review. J Cardiovasc Nurs 2017; 32: 260. doi:10.1097/JCN.0000000000000336 http://www.ncbi.nlm.nih.gov/pubmed/27111819
24 Thakkar J, Kurup R, Laba T-L, et al. Mobile telephone text messaging for medication adherence in chronic disease: a meta-analysis. JAMA Intern Med 2016; 176: 340–9. doi:10.1001/jamainternmed.2015.7667 http://www.ncbi.nlm.nih.gov/pubmed/26831740
25 ICT. Key ICT indicators for developed and developing countries and the world, 2016.
26 Bhatta R. Telemedicine and e-health in Nepal. Journal of Nepal Public Health Association 2015; 6: 41–6.
27 Chan A-W, Tetzlaff JM, Altman DG, et al. Spirit 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013; 158: 200–7. doi:10.7326/0003-4819-158-3-201302050-00583 http://www.ncbi.nlm.nih.gov/pubmed/23295957
28 Eldridge SM, Chan CL, Campbell MJ, et al. Consort 2010 statement: extension to randomised pilot and feasibility trials. BMJ 2016; 355: i5239. doi:10.1136/bmj.i5239 http://www.ncbi.nlm.nih.gov/pubmed/27777223
29 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 http://www.ncbi.nlm.nih.gov/pubmed/24609605
30 Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci 2011; 6: 42. doi:10.1186/1748-5908-6-42 http://www.ncbi.nlm.nih.gov/pubmed/21513547
31 Michie S, Atkins L, West R. The behaviour change wheel: a guide to designing interventions. 1st ed. Great Britain: Silverback Publishing, 2014: 1–255.
32 Abraham C, Michie S. A taxonomy of behavior change techniques used in interventions. Health Psychol 2008; 27: 379–87. doi:10.1037/0278-6133.27.3.379 http://www.ncbi.nlm.nih.gov/pubmed/18624603
33 Haricharan HJ, Heap M, Hacking D, et al. Health promotion via SMS improves hypertension knowledge for deaf South Africans. BMC Public Health 2017; 17: 663.
34 Aryal K, Neupane S, Mehata S, et al. Non Commincable diseases risk factors: steps survey Nepal 2013. Nepal Health Research Council, 2014.
35 Kim MT, Hill MN, Bone LR, et al. Development and testing of the Hill-Bone compliance to high blood pressure therapy scale. Prog Cardiovasc Nurs 2000; 15: 90–6. doi:10.1111/j.1751-7117.2000.tb00211.x http://www.ncbi.nlm.nih.gov/pubmed/10951950
36 Ogedegbe G, Mancuso CA, Allegrante JP, et al. Development and evaluation of a medication adherence self-efficacy scale in hypertensive African-American patients. J Clin Epidemiol 2003; 56: 520–9. doi:10.1016/S0895-4356(03)00053-2 http://www.ncbi.nlm.nih.gov/pubmed/12873646
37 WHO. Process of translation and adaptation of instruments, 2020. Available: https://www.who.int/substance_abuse/research_tools/translation/en/
38 Williams B, Mancia G, Spiering W, et al. 2018 ESC/ESH guidelines for the management of arterial hypertension: the task force for the management of arterial hypertension of the European Society of cardiology (ESC) and the European Society of hypertension (ESH). European heart journal 2018; 39: 3021–104.
39 Whitehead AL, Julious SA, Cooper CL, et al. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res 2016; 25: 1057–73. doi:10.1177/0962280215588241 http://www.ncbi.nlm.nih.gov/pubmed/26092476
40 Schwarz D, Dhungana S, Kumar A, et al. An integrated intervention for chronic care management in rural Nepal: protocol of a type 2 hybrid effectiveness-implementation study. Trials 2020; 21: 119. doi:10.1186/s13063-020-4063-3 http://www.ncbi.nlm.nih.gov/pubmed/31996250
41 Dettori J. The random allocation process: two things you need to know. Evid Based Spine Care J 2010; 1: 7–9. doi:10.1055/s-0030-1267062 http://www.ncbi.nlm.nih.gov/pubmed/22956922
42 Kim J, Shin W. How to do random allocation (randomization). Clin Orthop Surg 2014; 6: 103–9. doi:10.4055/cios.2014.6.1.103 http://www.ncbi.nlm.nih.gov/pubmed/24605197
43 Schulz KF, Grimes DA. Allocation concealment in randomised trials: defending against deciphering. Lancet 2002; 359: 614–8. doi:10.1016/S0140-6736(02)07750-4 http://www.ncbi.nlm.nih.gov/pubmed/11867132
44 Lachin JM. Statistical properties of randomization in clinical trials. Control Clin Trials 1988; 9: 289–311. doi:10.1016/0197-2456(88)90045-1 http://www.ncbi.nlm.nih.gov/pubmed/3060315
45 Lakshminarayan K, Westberg S, Northuis C, et al. A mHealth-based care model for improving hypertension control in stroke survivors: pilot RCT. Contemp Clin Trials 2018; 70: 24–34. doi:10.1016/j.cct.2018.05.005 http://www.ncbi.nlm.nih.gov/pubmed/29763657
46 Pieczkiewicz DSS. Patient attitudes toward electronic data entry of symptoms: survey development and preliminary results. Proceedings of the American Medical Informatics Association Fall Symposium, 2009: 1008.
© 2020 Author(s) (or their employer(s)) 2020. 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
; Narasimhan, Padmanesan 2
; Vaidya, Abhinav 3
; Jayasuriya, Rohan 2
1 School of Public Health and Community Medicine, University of New South Wales, Sydney, New South Wales, Australia; Central Department of Public Health, Tribhuvan University Institute of Medicine, Kathmandu, Nepal
2 School of Public Health and Community Medicine, University of New South Wales, Sydney, New South Wales, Australia
3 Department of Community Medicine, Kathmandu Medical College, Kathmandu, Nepal