Effects of a modular behavioural arthritis education ... - Oxford Academic

Rheumatology Advance Access published September 24, 2008 Rheumatology 2008; 1 of 7

doi:10.1093/rheumatology/ken380

Effects of a modular behavioural arthritis education programme: a pragmatic parallel-group randomized controlled trial A. Hammond1,2, J. Bryan3 and A. Hardy4 Objectives. Rheumatology guidelines recommend people with RA receive behavioural self-management education. This study developed a modular behavioural group programme and evaluated its longer term effects on pain, physical and psychological status. Methods. People with RA or PsA were randomized to a modular behavioural or standard information-focused education programme, both delivered by experienced rheumatology health professionals at one large district general hospital. Outcome measures were pain, selfefficacy, fatigue, functional ability, psychological status and use of health behaviours (exercise, joint protection, fatigue and cognitive symptom management). Using an intent-to-treat analysis outcomes were compared at 6 and 12 months with analysis of covariance. Results. Out of 498 referred patients, 218 agreed to participate, met entry criteria and were randomized; 51 withdrew before education. Of the remaining patients, 86 attended the behavioural and 81 the standard programmes. Participants were aged 55.4 yrs (S.D. 12.42) with disease duration of 7.39 (S.D. 6.88) yrs (53% 2 (score range 0–3), that is severe functional problems [21].

Procedures Derbyshire Research Ethics Committee approval was obtained. Over a 21-month period, rheumatology team members at one large district general hospital were asked to refer all patients meeting entry criteria to education. Patients were mailed an education programme and study invitation letter, screening, reply and consent forms. The letter emphasized that education was an important part of treatment and was signed by the rheumatology consultants. The study was described as comparing two types of group education programme with similar content, but using different teaching approaches. Participants could not be blinded to programme allocation but programme differences were not discussed during the study. Patients could attend the standard education programme as part of normal treatment without study participation. Those indicating willingness to participate were telephoned by a research administrator, the study discussed and opportunity to ask questions provided. The consent procedure was explained and participants’ written consent obtained by mail. Following consent, participants were immediately randomized by a research administrator to the modular or standard programme using computer-generated random numbers in preprepared sealed, opaque, numbered envelopes. No stratification was used. Participants were then telephoned by a research administrator to arrange attendance to either the modular or standard programme as allocated. Options of course start dates, times and

Programme providers could not be blinded to group allocation.

Standard programme. This was provided by rheumatology team members experienced in programme delivery. No additional training was needed. A programme manual was developed from observation of the existing programme. Team members reviewed and revised content and audiovisual aids, and used the manual throughout the trial. The programme consisted of five 2-h meetings including talks each week from a different member of the team and group discussion. Meeting 1 included: what is arthritis, how it affects joints and other parts of the body, drug treatments and tests, managing arthritis (rheumatology nurse and consultant rheumatologist); Meeting 2: exercise (including stretch programme with 30 min demonstration and practice), rest, posture and pain management [using heat and cold, transcutaneous electrical stimulation (TENS), massage] [physiotherapist (PT)]; Meetings 3 and 4: joint protection (including 45 min demonstration and practice), managing fatigue, aims of splinting, managing stress and relaxation (45 min practice), foot care [occupational therapist (OT)]; Meeting 5: healthy diet, complementary therapies, Social Security benefits and open discussion (nurse, OT, PT, social worker). Usually the same OT attended each week to facilitate discussion and programme management. Relevant Arthritis Research Campaign and Arthritis Care booklets were provided. Eight to 12 people were invited to attend each programme.

The LMAP. This included two modules, each with four 2.5 h meetings, and one 2-h review meeting. The first author wrote manuals for each module, which were piloted and revised following patient feedback. Three experienced therapists (one rheumatology OT, one community OT and one rheumatology PT) delivered modules. To standardize programme delivery, a two-day training course for each module (led by A.H.) was completed by therapists. This explained: evidence for programme interventions; patient education and behavioural change methods; tips for good teaching practice (e.g. voice modulation, eye contact, open questions, reflecting back, positive feedback); programme structure; and role play of sessions emphasizing group processes, teaching techniques and skills teaching. A.H. delivered a programme observed by the therapists. The therapists were then observed delivering a programme and given feedback on performance. Module manuals enabled adherence to programme content. Participants could attend the two LMAP modules and review meeting over a 3- to 9-month period, as convenient to them. Six people could attend module 1 (‘Looking After Your Joints’), 7–10 module 2 (‘Keeping Mobile and Managing Pain and Mood’) and up to 12 the review meeting. Each meeting included self-monitoring, skills training with individualized feedback and advice, goal-setting and action planning to follow individually determined home activity and exercise programmes working towards recommended frequency targets. Module 1 was developed from a behavioural joint protection programme [10]. Meeting 1 discussed RA and PsA, health beliefs, personal impact of arthritis, understanding multiple factors affecting symptoms, attitudes (self and others), personal experiences of what helps, selfmanagement methods and motivating for change. These themes

Lifestyle management for arthritis recurred throughout. Meetings 2–4 focused on applying ergonomic approaches to reduce pain (45–60 min weekly skills practice), hand exercises (flexibility and strengthening: 20–30 min weekly practice), fatigue management (e.g. activity pacing, microbreaks, planning, posture) and benefits of splints. This module had already been modified following feedback from previous participants and therapists [10, 12]. An example of part of the LMAP workbook (meeting 1) is provided in supplementary data available at Rheumatology Online. In Module 2, initial discussions focused on participants’ exercise beliefs, barriers and problem-solving these. Exercise included: a flexibility and strengthening exercise programme (30 min weekly practice); a graded home walking programme [22] (increasing over time to at least 30 min 5 days per week); and the warm-up and first 6 moves of the Tai Chi for Arthritis programme (30 min weekly practice) [23]. Tai Chi was selected as it improves lower limb movement, is enjoyable [24] and is becoming more widely available. Experiencing a group physical leisure activity could also increase confidence in attending community classes. Information on local exercise and swimming facilities were promoted to encourage continuing exercise. Footwear and foot care advice were given to facilitate mobility and podiatry referral if needed. Cognitive symptom management included stress management and coping with automatic negative thoughts. Pain management included use of heat and cold massage, TENS, distraction and relaxation practice (deep breathing and progressive neuromuscular facilitation 10–30 min weekly for three meetings). The review meeting included progress with goals, drug therapy, investigations, communicating with health professionals, team care and topics of participants’ choice (e.g. diet, complementary therapies, work support services, Social Security Benefits). See supplementary figure 2, available as supplementary data at Rheumatology Online for an LMAP summary. Module B and the review meeting were piloted and changes made following participant feedback. These included spending more time on practising exercise, foot care, explaining about drug therapy and blood tests and providing information on appropriate community-based physical leisure activities. Participant workbooks were provided for each module with key points, illustrations and diaries to record practising joint protection, pacing and exercise. A range of relevant Arthritis Research Campaign and Arthritis Care booklets were provided. Each module was delivered by one group leader to facilitate: continuing discussion of themes (e.g. adjusting to living with arthritis, coping, impact of arthritis on the family, managing at work), negotiating home programmes and weekly review of progress with goals. Flexibility and promoting group interaction allowed tailoring of content to participants’ needs (e.g. applying joint protection at work, coping with negative attitudes at work) and problem solving to generate solutions.

Outcome measures All outcome measures were collected using self-report questionnaires. The primary outcome measure was change in scores at 12 months on a 0–100 mm pain visual analogue scale (VAS, ‘no pain’ to ‘pain as bad is it can be’). Secondary outcome measures included: (i) Physical status: the modified HAQ assessing functional ability (0–3 scale) [21]; a 100 mm fatigue VAS (‘no problem’ to ‘a major problem’); a 0–100 mm VAS of perceived health (‘very bad’ to ‘very well’); duration of early morning stiffness (in minutes). (ii) Psychological status: the RA Self-efficacy (RASE) Scale, evaluated belief about using 28 self-management behaviours [25]; the Arthritis Self-efficacy Scale (ASES) evaluated belief in ability to manage pain and other symptoms [26]; the psychological distress scale of the multidimensional

3 of 7

HAQ includes four questions on sleep, stress, anxiety and depression [27]; and the Helplessness and Internality subscales of the Arthritis Helplessness Index measuring perceived control [28]. (iii) Self-management: the Arthritis Stages of Change Questionnaire evaluated readiness to change to manage arthritis, with four sub-scales of pre-contemplation, contemplation, action and maintenance [29]; use of self-management behaviours in the previous week: exercise (stretch, strengthening and aerobic); cognitive symptom management (e.g. relaxation, positive thinking, distraction) [30]; joint protection; and fatigue management. (iv) Health care use: self-reported number of visits to physicians during the last 6 months; current medication (whether taking DMARDs, NSAIDs or low-dose oral steroids). (v) Biographical information on age, gender, marital status, disease duration, occupation and work status were recorded.

Sample size Using pain VAS data derived from participants with RA in a trial evaluating an earlier version of Module 1 [mean score 53.4 (S.D. 23.75)] [10], assuming a 20% difference between groups, a power of 80% at the two-tailed 5% significance level, a minimum of 78 patients were needed in each group.

Statistical analysis An intention-to-treat analysis was conducted. Differences in clinical and demographic variables at baseline between participants remaining in the trial vs lost to follow-up were assessed using 2 or unpaired t-tests as appropriate. Mean change (S.D.) scores for outcome measures from 0 to 6 months and from 0 to 12 months were calculated. Scores were compared using analysis of covariance to identify whether any significant differences occurred. Analysis was conducted with baseline scores of the outcome variable as covariates. Data were analysed using SPSS version 12.1.

Results Recruitment and retention The trial flowchart is shown in Fig. 1. Of those referred, 65% (324/499) wished to attend a group education programme. However, only 44% overall (218/499) were willing to participate in the trial and met the entry criteria. Following randomization, 51 of the 218 (23%) withdrew: no longer wished to attend education (n ¼ 40); unable to attend due to work or childcare commitments (n ¼ 6) or too ill (n ¼ 5). This was a similar withdrawal rate to non-trial patients attending the standard programme as part of usual treatment (27% non-attendance). There were no significant differences at baseline between participants remaining in the trial vs the 17% lost to follow-up (data not shown).

Background characteristics, attendance and co-interventions The two groups were similar in demographic and baseline variables (Tables 1 and 2). Similar numbers continued to take DMARDs at 1 yr (74 in the standard vs 74 in the LMAP group), with no significant differences between groups (2 ¼ 0.28, P ¼ 0.20). Similar numbers remained in employment throughout (P ¼ 0.70). There was no significant difference in the average attendance rate between the two groups, with 4.09 (S.D. 1.09) per five meetings (average 81.72% attendance) for the standard and 7.73 (S.D. 1.96) per nine meetings (average 85.92% attendance) for the LMAP (2 ¼ 85.39; P ¼ 0.21), suggesting that both were popular. Nine people in the standard and 10 in the LMAP groups attended less than half of the meetings. In the LMAP group, average time to

A. Hammond et al.

4 of 7

Referred = 499 Declined = 34

Not replied to 3 or 4 invitations = 140

Agreed to attend Standard programme, but not enter trial = 80 Of these, did not attend = 22 (27.5%).

Agreed, not met entry criteria = 27. Offered Standard programme. Of these, did not attend = 7 (25.92%) Randomized

Standard programme = 109 Withdrew prior to assessment = 23 Unable to attend (work/childcare) = 3; illness = 2

Modular programme = 109 Withdrew prior to assessment = 17 Unable to attend (work/childcare = 4); illness = 2

Assessment 0 months = 81

Assessment 0 months = 86

Standard programme = 81

Module 1 = 86

Module 2 = 76

Review meeting = 67

Assessment 6 months = 73 Not replied = 8 (10%)




FIG. 1. Trial flowchart.

complete the whole programme was 4.93 (S.D. 2.23) months; with 66 (77%) taking up to 6 months; nine (10%) 7 months; 10 (12%) 8–9 months; and one (1%) 12 months. The majority (94%) completed the modules before returning the second questionnaire. There were no significant differences between good and poor attendees apart from the latter having significantly greater fatigue [63.53 (S.D. 27.55) vs 49.31 (S.D. 24.96), t ¼ 2.31, P ¼ 0.02]. Participants in both groups could continue to attend for occupational or physiotherapy as appropriate, with no significant difference between the groups (6 months: number of standard group therapy attendances to OT/PT ¼ 1.98 (S.D. 5.10), LMAP ¼ 1.50 (S.D. 5.56), t ¼ 0.57, P ¼ 0.57; 12 months: standard group OT/PT attendances ¼ 1.04 (S.D. 3.38), LMAP ¼ 1.07 (S.D. 3.90), t ¼ 0.06, P ¼ 0.95).

Outcome measures There were significant differences between groups at 6 months. The LMAP, compared with the standard programme, led to

significantly improved pain, fatigue, functional ability, perceived health, self-efficacy for self-management (RASE), selfefficacy for controlling arthritis symptoms (ASES) and perceived control of arthritis, alongside significant reductions in psychological distress and helplessness (Tables 2 and 3). Significantly more participants in the LMAP had moved into the Action stage of change. Use of exercise and joint protection were significantly higher, and recalled consultations with a GP or consultant about arthritis were also significantly lower (Tables 4 and 5). By 12 months, improvements had attenuated but improvements in pain, self-efficacy, perceived control, helplessness, being in the Action stage of change, use of joint protection and fatigue management techniques continued (Tables 2 and 5). Staffing, resource and course materials costs were: £149 per patient based on eight patients attending each standard programme; and £208 per patient based on six people in Module 1, nine in Module 2 and 12 in the review meeting for the LMAP (supplementary Table 6, available as supplementary data at Rheumatology Online).

Lifestyle management for arthritis TABLE 1. Baseline characteristics of participants

Gender, M/F Age, mean (S.D.), yrs Married/living with partner, n (%) Working full or part-time, n (%) Diagnosis RA, n (%) IA, n (%) P&A, n (%) Diagnosis, mean (S.D.), yrs