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The purpose of the study was to determine the effect of the Arthritis Self-Management Program (ASMP) on a cohort of patients, primarily African American (90 %), with rheumatoid arthritis (RA) served by a public hospital. One hundred four patients were randomly assigned to the ASMP group or the usual care group and followed for 18 months. The primary endpoint was clinical improvement indicated by the American College of Rheumatology (ACR20). Focus groups were conducted to provide contextual data. The percentages of patients achieving ACR20 were similar in the ASMP (14 % at 18 months) and usual care (17 %) groups (p=0.3). However, 28 % of the 25 ASMP patients that attended four or more classes achieved ACR 20 after 18 months of follow-up, but only 5 % of the 27 ASMP patients that attended less than four classes achieved ACR20 (P=0.1). There was a reduction in the tender and swollen joints in both groups over time (P=0.02), and those aged 60 and over had fewer joints involved. Half of the cohort fell at or below the poverty level. The percentages of patients achieving ACR20 were similar in the ASMP and usual care groups. Patients who attended four or more ASMP classes improved the most, but included only half of those assigned to ASMP. This suggests a need for innovative participant retention strategies or a different type of self-management program for this population.[PUBLICATION ABSTRACT]
Clin Rheumatol (2013) 32:4959
DOI 10.1007/s10067-012-2090-5
ORIGINAL ARTICLE
The effect of the Arthritis Self-Management Program on outcome in African Americans with rheumatoid arthritis servedby a public hospital
Doyt L. Conn & Yi Pan & Kirk A. Easley &
Dawn L. Comeau & Joyce P. Carlone & Steven D. Culler &
Athan Tiliakos
Received: 28 June 2012 /Revised: 30 August 2012 /Accepted: 10 September 2012 /Published online: 29 September 2012 # Clinical Rheumatology 2012
Abstract The purpose of the study was to determine the effect of the Arthritis Self-Management Program (ASMP) on a cohort of patients, primarily African American (90 %), with rheumatoid arthritis (RA) served by a public hospital. One hundred four patients were randomly assigned to the ASMP group or the usual care group and followed for 18 months. The primary endpoint was clinical improvement indicated by the American College of Rheumatology (ACR20). Focus groups were conducted to provide contextual data. The percentages of patients achieving ACR20 were similar in the ASMP (14 % at 18 months) and usual care (17 %) groups (p00.3). However, 28 % of the 25 ASMP patients that attended four or more classes achieved ACR 20 after 18 months of follow-up, but only 5 % of the 27 ASMP patients that attended less than four classes achieved ACR20 (P00.1). There was a reduction in the tender and swollen joints in both groups over time (P00.02), and those aged 60 and over had fewer joints involved. Half of the cohort fell at or below the poverty level. The percentages of patients achieving ACR20 were similar in the ASMP and usual
care groups. Patients who attended four or more ASMP classes improved the most, but included only half of those assigned to ASMP. This suggests a need for innovative participant retention strategies or a different type of self-management program for this population.
Keywords African Americans . Clinical outcomes . Patient self-management . Rheumatoid arthritis
Introduction
Rheumatoid arthritis (RA) occurs in approximately 1 % of the population, affecting poor and minority populations more adversely than those who are economically advantaged and Caucasian [1]. Economically disadvantaged patients have more active disease, disability, and reduced self-efficacy [2]. They also have lower functional status (Health Assessment Questionnaire, HAQ) at RA presentation and at 3 years [3]. Functional status is determined by disease activity, joint damage, helplessness, depression, pain, age, race, and comorbid conditions (diabetes mellitus and cardiovascular disease) [46]. Just how ethnic, social, and economic factors influence outcome in RA is not well understood.
Pharmacological management of RA with disease-modifying antirheumatic drugs (DMARDs), glucocorticoids, and biologics has beneficial effects on outcome as indicated by functional assessments and x-ray bony changes, particularly if used early in the course of disease [79]. Nonpharmacological factors can also augment pharmacological treatment benefits. Over the past two decades, the Arthritis Self-Management Program (ASMP) has become recognized as an important tool in the management of RA and is capable of improving self-efficacy, pain, and cost savings [10]. However, most studies of the ASMP utilize community-based
D. L. Conn (*) : J. P. Carlone : A. TiliakosDivision of Rheumatology, Emory University School of Medicine, Atlanta, GA, USAe-mail: [email protected]
Y. Pan : K. A. EasleyDepartment of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA, USA
D. L. ComeauDepartment of Behavioral Sciences and Health Education, Rollins School of Public Health, Emory University, Atlanta, GA, USA
S. D. CullerDepartment of Health Policy and Management, Rollins School of Public Health, Emory University, Atlanta, GA, USA
50 Clin Rheumatol (2013) 32:4959
volunteers who are largely Caucasian and have a higher socioeconomic status [11]. Contradicting these findings are studies suggesting that self-management programs may not be clinically effective or cost effective in primary care settings [1214]. There are no reported studies that have studied the ASMP in economically disadvantaged, African American patients with RA. The current investigation examined whether the ASMP could be successfully offered and contribute to better outcomes in this cohort.
Materials and methods
Clinical trial design
We selected RA patients meeting entrance criteria from the Grady Hospital Arthritis Clinic in Atlanta, GA, USA. Most were African American and financially disadvantaged. After obtaining informed consent, patients were randomized into either the treatment arm, which included providing an educational manual and participation in the ASMP, or the control arm. Both groups were provided with the usual care offered in the Grady Rheumatology Clinic. Usual care in our clinic includes the use of NSAIDs, low doses of prednisone (10 mg/day), and DMARDS, depending on the extent and activity of disease. Patients are regularly followed and treatment adjusted depending on disease activity. Physical therapy and surgical options are offered as indicated.
Random, permuted blocks were used to ensure balance between numbers of subjects assigned to each group. The patients were evaluated at 6, 12, and 18 months following enrollment. At the completion of the intervention, we conducted three focus groups to collect qualitative data on the respondents' experiences with the intervention. Qualitative data provides context and meaning to quantitative results and explores the experience from the patient perspective [1517]. The study was approved by the Emory University Institutional Review Board and by the Grady Hospital Research Oversight Committee.
Patient selection
Inclusion criteria included the diagnosis of RA according to the 1987 ACR Classification of RA [18], ages 2075, and seen at the Grady Arthritis Clinics. Exclusion criteria included limited mental capacity from a congenital brain disorder, psychosis, depression, or drug dependency that would limit the ability to understand instructions. Uncontrolled chronic diseases were excluded such as chronic lung disease patients on oxygen with limited ambulation, uncontrolled congestive heart failure, stroke, end stage renal disease, sickle cell anemia, HIVAIDS, or insulin-dependent complicated diabetes mellitus that, in the opinion of the investigator, would complicate evaluation and
follow-up. Literacy level was checked and those unable to read at the sixth grade level were not included. Only two to three patients were excluded on this basis. Patients were not excluded for rheumatoid joint deformities. Patients with uncomplicated chronic diseases such as asthma, depression, heart disease, high blood pressure, diabetes mellitus, and kidney disease (serum creatinine less than 2 mg%) were included.
Primary endpoint
The primary endpoint was the percent of patients who achieved 20 % improvement from baseline according to the ACR20 [19]. This was defined as 20 % improvement in tender and swollen joint counts plus 20 % improvement in three of five ACR core set measures: patient and physician global assessments, pain, disability (as measured by HAQ), and erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP).
Secondary endpoints
Changes in physical and mental status were measured using the Short Form (SF-36) [20] and the helplessness index of the Rheumatology Attitudes Index (RAI) [21].
Interventions
The 6-week ASMP was provided at Grady Hospital by an instructor identified by the Georgia Chapter of the Arthritis Foundation. The same instructor participated in all programs. Groups of six to ten consenting patients assigned to the treatment arm were asked to participate in weekly 2-h sessions for 6 weeks. The course was provided every 3 to 6 months during the first 18 months of the study. Conventional wisdom is that attendance at four or more sessions of the ASMP course indicates completion of the course (personal communication, Teresa Brady, Ph.D., Senior Behavioral Scientist, Arthritis Program, Centers for Disease Control). The ASMP was supplemented by an educational manual written at an eighth grade reading level.
Data collection
Data were collected at enrollment and every 6 months for 18 months. Baseline demographic information included age, gender, marriage status, occupation, income, insurance and disability status, RA duration, and other diseases. Tender and swollen joint counts, weight, prescribed arthritis medications, complete blood count (CBC), comprehensive chemistry, ESR, and CRP were obtained at each visit. Questionnaires included a visual analog pain scale, visual analog patient and physician global assessments, HAQ-DI (disability index) [22], SF-36, RAI, and Patient Satisfaction Questionnaire, Short Form (PSQ-18).
Clin Rheumatol (2013) 32:4959 51
Sample size and power considerations
The primary endpoint was the percent in each group that achieved ACR 20. Group sample sizes of 50 subjects in the ASMP group and 50 subjects in the control group would achieve 82 % statistical power to detect a difference between the group proportions of 25 %. The proportion in the ASMP group assumed to achieve ACR 20 would be 10 % under the null hypothesis and 35 % under the alternative hypothesis. The proportion that would attain ACR 20 was assumed to be 10 % in the control group. The test statistic used was the two-sided Z test with continuity correction and pooled variance. The significance level of the test was 0.05. Sample size calculations were performed using PASS 2005 software.
Statistical analysis
Primary analysis of the data was performed according to the patients' original intervention assignments (i.e., intention-to-treat analysis) and the inclusion of all data from all patients randomized in the final analysis. Baseline demographic and clinical characteristics were compared between intervention groups with the Wilcoxon rank-sum test for continuous variables and the chi-square test or Fisher's exact test for proportions.
Repeated-measures analyses of HAQ scores, log ESR, and log CRP were done with a means model with SAS Proc Mixed (version 9.2) providing separate estimates of the means by time on study (baseline, 6, 12, and 18 months) and intervention group. A compound symmetric variance covariance form in repeated measurements was assumed for each outcome, and robust estimates of the standard errors of parameters were used to do statistical tests and construct 95 % confidence intervals [23]. The model-based means were unbiased with unbalanced and missing data, so long as the missing data were noninformative (missing at random). A dropout process was assumed to be missing at random if, conditional on the observed data, the dropout was independent of the unobserved measurements. For multivariable analysis, this model was refitted including the following baseline covariates: employment status (yes or no), primary insurance (any or none), disease duration (<5 years or 5 years), age (60 or <60), and adherence to oral steroids and methotrexate at each of the four scheduled visits. Statistical tests were two-sided. A p value <0.05 was considered statistically significant.
The generalized estimating equations (GEE) approach of Liang and Zeger [24] was used to analyze the longitudinal count data (total number of tender and swollen joints) and the repeated binary responses for the ACR 20 outcome. The count data on tender and swollen joints obtained at baseline, 6, 12, and 18 months were compared between the ASMP and usual care groups by performing a GEE Poisson regression analysis implemented using SAS Proc Genmod with an
exchangeable correlation structure for the repeated count data within the participant. The model-based estimates were unbiased with unbalanced and missing data, so long as the missing data were noninformative (missing completely at random). A GEE analysis was also performed for the repeated binary responses within the participant for the ACR 20 data (exchangeable correlation binomial logit model). Both the Poisson model and the binomial logit model were refitted to adjust for baseline covariates (employment status, primary insurance, disease duration, age, and adherence).
Focus groups
All focus groups were led by the same experienced interviewer. The first group comprised of nine patients who had participated in all aspects of the intervention including attendance at four or more ASMP classes. Group 2 included six patients that were randomized to the intervention group but had participated in less than four of the ASMP classes. Group 3 consisted of nine patients that came from the usual care or control group. The first two groups were asked to discuss the benefits of the intervention on their quality of life with RA. The third focus group discussed the impact of usual care on living with RA.
Results
One hundred four participants were randomly assigned to the ASMP group or the usual care group. Nine patients in the ASMP group and four patients in the usual care group were lost to follow up due to change of location, change of or loss of insurance, or loss of communication by phone and mail (Fig. 1).
Baseline demographic and clinical characteristics are summarized in Table 1. An intention-to-treat analysis was performed. Most of the participants were female (79 %), African American (90 %), and not employed (88 %). Fifty-one percent of the participants did not have health insurance. In the ASMP group, 79 % were female, with a mean age at enrollment of 54.2 years, and median disease duration of9.1 years. In the usual care group, 79 % were female, mean age was 52.9 years, and the mean disease duration was6.4 years. The demographic and clinical characteristics of the two study groups were similar except for employment status (p00.02). Only 3.8 % in the ASMP group and 21.2 % in the usual care group were employed. The percentage of patients with other chronic diseases was the same in both groups, ranging from 12 % with heart disease to 65 % with hypertension. Approximately 50 % of the patients in both groups fell at or below the poverty level [25].
52 Clin Rheumatol (2013) 32:4959
Fig. 1 Consort diagram of the progress through the phases (enrollment, intervention allocation, follow-up, and data analysis) of a parallel randomized trial of two groups (the Arthritis Self-Management Program [ASMP] and the usual care group)
Enrollment
Randomized (n=104)
Allocation
Allocated to ASMP (n= 52) Received allocated intervention (n=51)
Did not receive allocated intervention (n=1) *One patient who was assigned to ASMP received usual care.
Allocated to Usual Care (n=52) Received allocated intervention (n=51)
Did not receive allocated intervention (n=1)* One patient who was assigned to usual care received ASMP.
Follow-Up
Lost to follow-up (n= 9) 3 moved out of state
5 Unable to locate*. Last seen 15
months ago
1 changed insurance/provider* the phone was disconnected and they did not respond to mailed letters
Lost to follow-up (n= 4) 4 Unable to locate*. Last seen 15
months ago
* the phone was disconnected and they did not respond to mailed letters
Analysis
Analysed (n= 52) 18 missed 6 Months visits 16 missed 12 Months visits 18missed 18 Months visits*by total tender and swollen joints
Analysed (n=52) 13 missed 6 Months visits 17 missed 12 Months visits 10 missed 18 Months visits*by total tender and swollen joints
Disease activity as indicated by number of tender and swollen joints, HAQ, and ESR was similar in both groups at baseline (Table 1). Total tender joints in the two cohorts changed in similar ways during follow up (p00.4, test for interaction between time on study and intervention group, Table 2 and Fig. 2a). No difference was detected between the two groups (p00.7), but there was a statistically significant difference over time (p00.02). The mean number of total tender joints (from univariate repeated-measure model) was similar in both groups at baseline, 8.1 for ASMP and8.0 for usual care. This became lower at 6 months (4.6 and6.0) followed by an increase at 18 months (6.2 and 7.1). Multivariable analyses, which adjusted for other potentially important baseline covariates (Table 3), suggested an age effect (p00.008) but the mean number of total joints was not different based on employment status (p00.08), insurance status (p00.4), disease duration of arthritis symptoms (p00.3), or adherence to oral steroids and methotrexate (p00.1). Participants 60 years of age at enrollment had fewer tender joints (mean03.4) compared to participants <60 years at enrollment (mean05.5).
Study results for total swollen joints were similar to the findings for total tender joints. Total swollen joints in the two cohorts changed in similar patterns during the 18-month
follow up period (p00.6, test for interaction between time on study and intervention group, Table 2 and Fig. 2b). No difference was detected between the cohorts (p00.7), but there was a statistically significant difference over time (p00.02). The mean number of total swollen joints was similar in both cohorts at baseline (7.1 and 8.3, respectively, for ASMP and usual care) but became lower at 6 months (4.6 and 5.0) followed by an increase at 18 months (5.0 and 6.2). Multivariable analyses, which adjusted for other potentially important baseline covariates (Table 3), suggested no age effect (p00.09) and no difference based on employment status (p00.2), insurance status (p00.9), disease duration (p00.7), or medication adherence (p00.4). Participantsage 60 at enrollment had fewer swollen joints (mean03.7) compared to participants<age 60 at enrollment (mean05.0), but this difference was not statistically significant.
HAQ scores were similar for the two cohorts throughout follow up (p00.9, test for interaction between time on study and intervention groups, Table 2 and Fig. 2c). No differences were detected between the groups (p00.3) and no time effect was identified (p00.7). Multivariable analyses (Table 3) showed an age effect (p00.0009) and an effect of employment status (p00.002) but no differences based on insurance status (p00.9), disease duration (p01.0), or
Clin Rheumatol (2013) 32:4959 53
Table 1 Patient demographic and baseline clinical characteristics
Variables ASMP (n052) Usual care (n052) P value
Gender Male 11/52 (21.2 %) 11/52 (21.2 %) 1.0Female 41/52 (78.8 %) 41/52 (78.8 %)
Ethnicity Black 47/52 (90.4 %) 47/52 (90.4 %) 1.0White 3/52 (5.8 %) 2/52 (3.8 %)
Other 2/52 (3.8 %) 3/52 (5.8 %)
Employed No 50/52 (96.2 %) 41/52 (78.8 %) 0.02Yes 2/52 (3.8 %) 11/52 (21.2 %)
Primary insurance Anyc 29/52 (55.8 %) 22/52 (42.3 %) 0.2
None 23/52 (44.2 %) 30/52 (57.7 %)
Household income 15 k 19/36 (52.8 %) 18/37 (48.7 %) 0.7>15 k 17/36 (47.2 %) 19/37 (51.4 %)
Education High school or lower 38/52 (73.1 %) 28/52 (53.8 %) 0.05 Age at baseline (years) Mean (SD) 54.2 (8.2) 52.9 (10.2) 0.5 BMI (kg/m2) 31.1 (7.3) 31.1 (7.5) 1.0 HAQ score 1.6 (0.7) 1.5 (0.8) 0.4 Patient assessmentHow well are you doing? 53.5 (27.1) 53.9 (30.0) 0.8 How much pain have you had? 66.4 (25.0) 57.8 (31.4) 0.1 Physician global assessment 30.2 (17.5) 29.5 (19.3]) 0.8 SF-36 (normalized)Physical component summary 31.1 (8.1) 31.4 (10.4) 1.0 Mental component summary 43.3 (13.9) 46.6 (14.1) 0.2 RAI score 3.1 (1.0) 3.2 (0.9) 0.7 Duration since onset of arthritis symptoms (years) median (25th, 75th quartiles) 9.1 (5.0, 12.5) 6.4 (2.4, 10.9) 0.1 Joint countTotal swollen joints 5.0 (3.0, 9.5) 6.0 (3.0, 12.0) 0.5 Total tender joints 5.0 (4.0, 9.0) 6.0 (3.0, 11.0) 0.9
ESRa (mm/h) 34.0 (20.0, 53.0) 34.0 (28.0, 56.0) 0.5 Oral steroid 46/52 (88.5 %) 45/52 (86.5 %) 0.8 Methotrexate 34/52 (65.4 %) 36/52 (69.2 %) 0.7 Any biologic agentb 6/52 (11.5 %) 6/52 (11.5 %) 1.0
a n is 47 in ASMP and 47 in usual care
b Contains adalimumab and etanercept
c 31 % Medicare, 14 % Medicaid
adherence to oral steroids and methotrexate (p00.8). Participantsage 60 at enrollment had lower HAQ scores (mean00.94) compared to younger participants (mean01.41), and employed participants had better HAQ scores (mean00.86) compared to unemployed participants (mean01.50). Mean ESR and CRP levels were similar for the two cohorts throughout the follow up (data not shown).
The percentage of participants that achieved ACR 20 was less than 20 % throughout the 18 months of follow up (Table 2 and Fig. 2d). The percentage of participants achieving ACR 20 increased slightly over time in the ASMP group (9 %, 11 %, and 14 % at 6, 12, and 18 months) but decreased slightly in the usual care group (20 %, 13 %, and 17 % at 6, 12, and 18 months).
However, the test for interaction between intervention group and time on study was not statistically significant (p00.7), indicating no difference in the pattern of change over time between the two cohorts. Additionally, there was no difference between the two groups in percentage of participants achieving ACR 20 (p00.3) and no difference due to time on study (p00.8). The ACR 20 results were similar after adjusting for possible baseline differences in covariates (age, employment status, insurance status, and disease duration, Table 3).
In a corresponding subset analysis, 27.6 % (95 % CI:10.8 % to 54.4 %) of the 25 ASMP participants that attended four or more classes achieved ACR 20 after 18 months, but only 4.7 % (95 % CI: 0.6 % to 29.5 %) of the 27 ASMP
54 Clin Rheumatol (2013) 32:4959
Table2Estimatedmeansand95%confidenceintervalsfortotaltenderjoints,totalswollenjoints,HAQscore,andACR20inunivariaterepeated-measuresmodel
OutcomeBaseline6-Month12-Month18-MonthInterventionTimeIntervention
bytime
NumberMean95%CINumberMean95%CINumberMean95%CINumberMean95%CIPvalue
528.06.210.2406.04.18.7355.33.87.2417.15.69.0
Pvalue0.70.020.4
Totalswollenjoints
ASMP527.15.59.1344.63.26.5365.53.88.0345.03.86.6
Usual
528.36.410.7405.03.47.4354.63.36.6416.24.18.7
Pvalue0.70.020.6
HAQscore
ASMP521.591.41
Pvalue0.30.70.9
ACR20
ASMP349 %3 %26%3611 %4 %
Pvalue0.30.80.7
341.571.37
411.51.27
3414%6%
4117%9%
1.77
Usual
1.72
30%
Usual
30%
331.621.441.80361.651.45
3513%5%
1.85
1.73
27%
30%
401.441.211.67351.531.33
4020%10%
35%
521.471.26
1.77
1.68
Totaltenderjoints
ASMP528.16.310.3344.63.16.7366.24.39.0346.24.68.2
Usual
care
care
care
care
Clin Rheumatol (2013) 32:4959 55
Fig. 2 Longitudinal changes in total tender joints (a), total swollen joints (b), HAQ score (c), and ACR20 (d) in patients with rheumatoid arthritis. The time trend lines are the model-based means and 95 % confidence intervals. The vertical bars are the 95 % confidence intervals
participants that attended less than four classes achieved ACR 20 after 18 months.
The use of DMARDs was similar in both groups at baseline. Eighty-seven percent of the patients were on daily prednisone, 10 mg or less. Sixty-seven percent were on methotrexate and 50 % were on other DMARDs, primarily hydroxychloroquine. Eleven percent were on biologics, either adalimumab or etanercept. By inquiry at each visit, approximately one-third of the patients were not on all of their DMARD medications. However, there was no difference in medication compliance between the groups.
The change in the physical and mental status as measured by the SF-36 and the helplessness index showed little change over time and was similar in both groups. The pain scale as assessed by the patient was also similar in both groups with minimal change over time.
Focus groups
All of the ASMP focus group respondents liked participating in the course and wanted to continue. The ASMP provided a source of social support and informal knowledge about how to manage life with RA. They also thought the RA manual was helpful in conjunction with the ASMP. Patients who were randomized to the ASMP but did not
attend all of the sessions gave the following reasons for lack of participation: lack of transportation, too much pain to get to class, and conflicting responsibilities. Those who did not fully participate wanted to attend ASMP classes after hearing more about them in the focus groups. Respondents in each group suggested a 24-h hotline that they could use when having difficulty with their RA.
Discussion
All patients had some reduction in the total number of tender and swollen joints over 18 months. HAQ scores, ESR, and CRP were similar in the two groups and throughout the course of the study. The HAQ was lower in those over age 60 and employed. There was little difference or change over time in the ACR20 between the two groups. However, in ASMP patients who were able to attend four or more of the self-management classes, there was a significant improvement in the ACR20.
The cohorts were primarily female African Americans with a mean age of 54 and half having a mean income of less than $15,000 per year. Most were unemployed and half had no insurance. Studies have shown the adverse effect of socioeconomic deprivation on outcome in RA [26]. A cross-
56 Clin Rheumatol (2013) 32:4959
Table 3 Estimated means and 95 % confidence intervals for total tender joints, total swollen joints, HAQ score, and ACR 20 in multivariable repeated-measures model
Total tender joints Total swollen joints HAQ score ACR 20a
Covariates Mean 95 % CI p value Mean 95 % CI p value Mean 95 % CI p value Mean 95 % CI p value
Treatment 0.4 0.4 1 0.2 ASMP 4.1 2.95.7 4.1 2.95.7 1.18 0.881.48 10 % 4 %24 %
Usual care 4.6 3.46.1 4.6 3.46.1 1.17 0.891.45 16 % 8 %32 % Time 0.02 0.02 0.7 0.9 Baseline 5.5 4.17.3 5.8 4.37.8 1.16 0.891.456-Month 3.6 2.55.0 3.6 2.65.2 1.16 0.881.45 13 % 5 %30 % 12-Month 3.9 2.85.5 3.8 2.75.4 1.22 0.941.50 12 % 5 %26 % 18-Month 4.5 3.46.1 4.2 3.15.7 1.16 0.811.46 14 % 6 %29 % Treatment by time 0.4 0.5 0.9 0.7 Baseline 5.3 3.87.4 5.2 3.67.5 1.16 0.841.476-Month 3.0 1.94.8 3.4 2.15.4 1.20 0.881.51 8 % 2 %28 % 12-Month 4.2 2.76.5 4.1 2.66.4 1.22 0.901.55 10 % 3 %27 % 18-Month 4.1 2.85.9 3.7 2.55.4 1.14 0.811.46 12 % 4 %32 %
Usual care baseline 5.6 4.07.9 6.4 4.69.0 1.16 0.871.45Usual care 6-month 4.2 2.86.3 3.9 2.65.9 1.13 0.821.44 20 % 8 %41 %
Usual care 12-month 3.7 2.55.4 3.6 2.45.4 1.22 0.911.52 13 % 4 %35 %
Usual care 18-month 5.0 3.67.0 4.9 3.56.8 1.19 0.881.50 16 % 7 %34 % Age 0.008 0.09 0.0009 0.9 <60 5.5 4.37.1 5 3.86.4 1.41 1.161.66 13 % 7 %24 %60 3.4 2.34.9 3.7 2.65.4 0.94 0.591.29 12 % 4 %33 % Employed 0.08 0.2 0.002 0.8 Yes 3.7 2.55.4 3.8 2.55.8 0.86 0.411.30 14 % 4 %40 %
No 5.1 3.96.5 4.9 3.96.2 1.50 1.321.67 12 % 6 %20 % Insurance 0.4 0.9 0.9 0.4 Yes 4.0 2.95.6 4.3 3.16.0 1.17 0.901.44 11 % 4 %24 %
No 4.6 3.46.3 4.3 3.15.8 1.18 0.861.50 15 % 6 %32 % Duration since onset
of arthritis symptoms
0.3 0.7 1 0.4
<5years 4.7 3.46.6 4.2 3.05.8 1.18 0.851.51 10 % 4 %25 % 5 years 3.9 2.95.3 4.4 3.36.0 1.17 0.921.43 16 % 8 %30 % Adherence to oral steroids
and methotrexate
0.1 0.4 0.8
Yes 4.9 4.06.1 4.0 3.75.9 1.16 0.921.43 No 3.8 2.55.7 4.7 2.66.0 1.20 0.821.58
a Adjustment for adherence to oral steroids and methotrexate was not possible for the ACR 20 outcome due to lack of model convergence perhaps due to ill conditioned data (multicollinearity between covariates)
sectional study of RA in minorities found that African Americans and Hispanics had significantly worse pain scores than Caucasians and a worse but not statistically significant difference in HAQ [27]. In the Norwalk, UK, Arthritis Registry, areas of residence and occupation (social class) influenced the function (HAQ) of RA patients. Those in the most deprived areas and of the lowest social class had the worst outcome [28]. Song et al. investigated racial and ethnic differences in disability among older Americans with arthritis (primarily osteoarthritis) using the longitudinal data, 19982004, from the Health and Retirement Study. A greater percentage of African Americans and Spanish-speaking Hispanics developed disability than Whites [29].
We know that race and economic status influence outcome in RA. How do those factors influence patients' participation in the ASMP? In our cohort, economic factors affected our patients' ability to regularly attend the ASMP. Issues, including lack of transportation or inability to pay for the bus or train, and need to care for dependent family members, influenced their ability to attend the ASMP. The fact that one-half of the ASMP patients could not attend a sufficient number of classes due directly to their economic status provides some insight into how poverty influences outcome in RA. For example, we know that those who regularly attended four or more sessions had a better outcome than those who did not. Another fact influencing
Clin Rheumatol (2013) 32:4959 57
outcome related to economic factors, but not an objective of this study, was the relative low percentage of our cohort on biologics. Uninsured patients who were candidates for biologics were sometimes able to get biologics through patient assistance programs. However, programs, such as Medicare, which required some copay were often out of reach for these patients.
Lorig et al. have shown that in patients with RA, the ASMP has resulted in improved pain, reduced disability, and reduced physician visits over 4 years compared to no self-management intervention. This was true of patients who were Caucasian and well educated [11]. In a study by Lorig et al. of the Chronic Disease Management Program, which included patients with arthritis, similar results were seen at 2 years with reduced ER visits and increased self-efficacy. Again, participants were recruited by public service announcements in the community and were primarily educated Caucasians. Participants who attended at least one session were included, and the mean attendance was six out of seven sessions [30]. Possibly the motivation of these participants and their ability to attend classes were different than a clinic population of minority, low income patients.
In a 1-year study examining the comparative effectiveness of the ASMP with the chronic disease self-management program of primarily African Americans with arthritis of all types, there was a significant improvement in self-efficacy, exercise compliance, and general health in both groups at 4 months. However, the improvement disappeared at year. These were community volunteers who had a mean level of education of 12 years [31].
A controlled study, similar to ours, by Grnning et al. of Norwegian patients with inflammatory arthritis compared their Arthritis Self-Help Course of three sessions to usual care. They showed improved global well-being, self-efficacy, and reduced pain at 4 months. There was a trend toward improvement in disease activity [32]. Likewise, a 24-h modular behavioral program for inflammatory arthritis compared with an ASMP-type program showed effectiveness in reducing pain and improving psychological status at 1 year [33]. However, two large Cochrane reviews of patient education and self-help management in RA showed some functional improvement at the initial evaluation after baseline, but not at the end of the study [34, 35]. A study to identify the reasons for limited results of group self-management in RA showed a link to low motivation to participate and change behavior [36].
The self-management approach has been recommended for management of people with arthritis by the CDC in Healthy People 2010 [37]. Using the 2002 and 2006 National Health Interview Survey and state-based 2003 and 2007 Behavioral Risk Factor Surveillance System, an estimate of change in behavior was studied. There was no change in the proportion of adults with arthritis who had ever taken a self-management education class, approximately 11 % [38]. This shows a poor
effort by physicians, clinics, and health care institutions to provide self-management. This may be because there are no financial incentives, the self-help course may be difficult to implement, and it may be perceived as ineffective.
Consequently, the ASMP, as it has been designed, may not be appropriate for the majority of poor African American patients with RA, as seen in our clinics. To achieve optimal participation, we might need an overlying program, possibly using trained individuals to make frequent patient contact and to remove attendance obstacles, similar to the program developed to facilitate HIV treatment of poor patients in Lima, Peru [39]. Unfortunately, such a program would be labor intensive and expensive. However, there are chronic care models that offer studied approaches that might be used to incorporate self-help into a clinic and evaluate its effect [40].
From our experience, the model would need to be simple, part of the clinic visit, geared to this population's interests and abilities, and offer social support. One approach might be to educate our nurses and fellows to incorporate the essentials of self-help into their interactions with patients. This could be an important part of a fellow's education. We could give the RA manual to all new RA patients. The person(s) to contact with problems must be emphasized. At the time of the weekly RA clinic, we could provide, in a separate room, an opportunity for the RA patients to interact. The challenge will be to design and evaluate any approach that is developed.
This study has several limitations. One is the modest sample size. Secondly, we had difficulty getting our intervention patients to attend sufficient numbers of ASMP classes. The focus groups provided some insight into attendance problems, namely, transportation, other obligations, and finances. Another limitation is that this was an open study and lacked blinding. It is difficult to blind patients to the fact that they are taking part in an educational program. Additionally, the study was only conducted at one site. In retrospect, the choice of ACR 20 was probably not the best disease activity index to use. The DAS 28 or another disease activity index may have been better. Nevertheless, the essentials of disease activity, tender and swollen joint counts, HAQ, inflammatory index (ESR or CRP), and patient and physician global assessments, were measured longitudinally.
We have shown that if patients attend four or more ASMP sessions, this will have a positive impact on their outcome as indicated by improvement in the ACR 20. Unfortunately, only one-half of the ASMP patients attended four or more sessions. The structured ASMP is difficult to conduct in a clinical setting with poor patients who have many obstacles to overcome to attend at least four sessions. Education, support, and empowerment of these patients are important and will provide an effective, adjunctive, nonpharmacological treatment modality. We think that such a program can be designed and implemented. The ASMP, in its current form, may not be that program.
58 Clin Rheumatol (2013) 32:4959
Acknowledgments This study was supported by The Physicians Foundation Grant No. 9600564.
Disclosures None
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