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Randomised controlled trial of a lay-led self-management programme for Bangladeshi patients with chronic disease |
Griffiths C, Motlib J, Azad A, Ramsay J, Eldridge S, Feder G, Khanam R, Munni R, Garrett M, Turner A, Barlow J |
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Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. Health technology The health intervention examined in the study was a lay-led self-management programme, the Chronic Disease Self-Management Programme (CDSMP) (Expert Patient Programme) for patients with chronic disease. The education programme focuses on a specific ethnic minority group of Bangladeshi patients and consists of a multifaceted model where an individual's beliefs about self-efficacy operate with their goals and expectations about the outcome of their actions to influence self-care behaviour.
The programme comprised 6, 3-hour sessions over six weeks, and took place in general practices or community centres. The sessions covered topics including symptom management, communication with health professionals, managing medication, exercise, and decision-making. The sessions were delivered by pairs of trained and accredited Bangladeshi lay tutors, most of whom had diabetes, who acted as facilitators.
Economic study type Cost-effectiveness analysis.
Study population The study population comprised Bangladeshi adult patients with diabetes, arthritis, respiratory or cardiovascular diseases.
Setting The setting was the community. The economic study was carried out in the UK.
Dates to which data relate The period during which effectiveness and resource use data were gathered was not reported. The price year was not given.
Source of effectiveness data The effectiveness evidence came from a single study.
Link between effectiveness and cost data The costing was carried out on the same sample of patients as that included in the effectiveness analysis.
Study sample Power calculations were carried out in the preliminary phase and a target of 108 patients per group would have allowed a significant effect size in the main outcome measure with 80% power and 5% significance, taking into account an expected 10% loss to follow-up. Eligible patients were recruited by writing to people listed on disease registers of 10 general practices serving large Bangladeshi populations in Tower Hamlets. Letters were then followed by a telephone call to identify patients interested in the study. Of the potential sample of 1,349 individuals initially contacted, 476 agreed to participate into the study, including 14 self-referrals. Financial incentives were also given to improve participation. Given this sample size, the study was powered to detect a 40% standard deviation change in self-efficacy with an 80% power and a 5% significance. The main reasons for not joining the study were no response (n=453) and unknown reason (n=371). There were 238 patients in each group. The mean age was 48.9 (+/- 9.9) years in the intervention group and 48.0 (+/- 9.5) years in the control group. Women made up 56% of the intervention and 58% of the control group. Most of patients had diabetes (66% in the intervention group and 71% in the control group).
Study design This was a prospective, randomised, clinical trial, which was carried out at several centres in Tower Hamlets, East London. Randomisation was based on a computer minimisation program, which allocated patients either to the education programme or the waiting list. Randomisation was stratified by main condition (diabetes, asthma, cardiovascular disease or arthritis), age and sex. Patients were followed-up for 4 months. Follow-up data were missing for 17 patients in the intervention group and 20 patients in the control group, thus follow-up data were available for 92% of participants (439/476). Interviewers blinded to the treatment allocation carried out the assessment of the clinical outcomes.
Analysis of effectiveness The primary analysis of the clinical data was based on intention-to-treat (ITT). However, a secondary analysis was based on treatment-completers only, which included participants who had attended three or more of the six education sessions. The primary outcome measure was self-efficacy, which was measured using six items from the Chronic Disease Self-Efficacy Scale. These items were general condition management, distress, non-medication management, discomfort, fatigue, and interference. Secondary outcomes were firstly self-management behaviour and communication with the doctor, which were assessed using scales from the same instrument, measuring use of cognitive symptom self-management and communication strategies, respectively. Other secondary outcomes were health status measured using the Hospital Anxiety and Depression Scale, 5-point Likert scales for pain, fatigue and breathlessness, and the EuroQol EQ5D. All outcomes were measured using face-to-face interviews. At baseline, study groups were comparable with respect to demographic and clinical characteristics. Regression analysis was carried out to adjust clinical outcomes by baseline factors.
Effectiveness results Three or more of the six sessions were attended by 51% of participants, while 20% attended one or two sessions and 21% attended none. Attenders and non-attenders did not differ with respect to demographic and clinical characteristics.
The ITT analysis showed that the intervention led to statistically significant improvements in self-efficacy and self-care behaviour. Specifically, the self-efficacy score (higher values represent better results) changed from 16.31 to 18.22 in the intervention group and from 16.39 to 17.62 in the control group, for an adjusted effect size of 0.67 (95% confidence interval (CI): 0.08 - 1.25; p=0.025).
The self-care behaviour score (higher scores represent better results) changed from 7.23 to 8.95 in the intervention group and from 7.16 to 8.31 in the control group, for an adjusted effect size of 0.53 (95% CI: 0.01 - 1.06; p=0.047).
Other outcomes were comparable across groups.
The secondary analysis, based on treatment-completers only, showed similar changes but at a greater effect size, while significant improvements in depression score (lower scores represent better results) were also observed with a change from 9.07 to 8.29 in the intervention group and from 8.64 to 8.49 in the control group (effect size: -0.64; 95% CI: -1.22 - -0.07; p=0.028).
Clinical conclusions The effectiveness analysis showed that the education programme led to moderate improvements in Bangladeshi patients with chronic diseases.
Measure of benefits used in the economic analysis Health outcomes were left disaggregated and no summary benefit measure was used in the economic evaluation. In effect, a cost-consequences analysis was carried out.
Direct costs The perspective adopted in the study was not explicitly stated. The analysis of costs included tuition costs (tutor's salaries) and administration costs (salary of an administrator and other administrative expenses). In addition, resource use associated with GP visits was estimated, but not costed as it was not statistically significantly different between the two groups. Unit costs were not presented separately from the quantities of resources used. Resource use was derived from the actual implementation of the education programme. The source of costs was not clearly reported. Discounting was not relevant since costs were incurred within a 2-year time frame. The price year was not reported.
Statistical analysis of costs Costs were treated deterministically.
Indirect Costs Indirect costs were not included in the economic evaluation.
Sensitivity analysis Sensitivity analyses were not performed.
Estimated benefits used in the economic analysis Please see the effectiveness results reported above.
Cost results Costs associated with GP visits did not differ between the two groups and hence were not calculated.
The tuition costs for the whole programme were 17,613.
The administration costs were 40,800.
The total costs in the whole sample of patients were 58,413, or 123 per participant.
Synthesis of costs and benefits A synthesis of costs and benefits was not relevant as a cost-consequences analysis was carried out.
Authors' conclusions The authors concluded that the 6-week chronic disease self-management programme among Bangladeshi patients improved participants' confidence to control chronic disease and altered their behaviour, increasing their use of self-management skills. The cost of the intervention was 123 per patient.
CRD COMMENTARY - Selection of comparators The rationale for the choice of the comparator was clear as waiting lists reflects the current treatment pattern for Bangladeshi patients with chronic disease. You should decide whether this is a valid comparator in your own setting.
Validity of estimate of measure of effectiveness The effectiveness evidence came from a clinical trial, which was appropriate for the study question. Information on randomisation and sample selection was extensively reported. The internal validity of the analysis was further enhanced by the use of power calculations, the baseline comparability of study groups, the stratification used when patients were allocated to the two groups, the high follow-up rate, and the use of blinding. The length of follow-up was short, as the authors acknowledged. Although a longer follow-up would have been more appropriate it may not have been feasible because of the high mobility of the Bangladeshi population. The analysis of the clinical outcomes was based on both ITT and treatment-completers only, and validated instruments were used to assess the impact of the intervention on patient health. These issues tend to limit the impact of confounding factors and bias, thus strengthening the level of evidence. However, a critical issue of the analysis was the low participation rate, which means that the intervention may not be applicable to all patients. The authors acknowledged the existence of social and spiritual barriers to attending classes.
Validity of estimate of measure of benefit No summary benefit measure was used in the analysis because a cost-consequences analysis was conducted. Please see the commentary reported above under 'validity of estimate of measure of effectiveness'.
Validity of estimate of costs The analysis of costs appears to have been a secondary objective of the study, as only limited information on the cost analysis was provided. Specifically, the source of costs and the perspective taken in the study were not explicitly stated. Unit costs were not extensively reported and a detailed breakdown of items was not provided. In effect, the implementation of the programme required only a few economic items. Costs associated with healthcare resource use were not estimated because this did not differ between groups. Statistical analyses of costs were not performed and cost estimates were specific to the study setting. In general, the lack of details limits the possibility of replicating the analysis in other settings.
Other issues The authors stated that the current findings agree with those in previous studies. However, the effect on clinical outcomes was more modest than that observed in other studies. The issue of the generalisability of the study results to other settings was not addressed, and sensitivity analyses were not performed, which limits the external validity of the analysis. The study enrolled only Bangladeshi patients, thus the conclusions of the analysis should apply to similar populations. The authors noted some strengths and weaknesses of the analysis, which have been reported in the above fields.
Implications of the study The study results suggest that a lay-led self-management programme for Bangladeshi patients with chronic disease could lead to a moderate effect in self-management of disease. The authors note that future studies should assess the validity of tools aimed at improving patients' attendance as well as the long-term impact of the programme on health status and physiological indicators.
Source of funding This research was funded by the NHS Primary Care Studies Programme.
Bibliographic details Griffiths C, Motlib J, Azad A, Ramsay J, Eldridge S, Feder G, Khanam R, Munni R, Garrett M, Turner A, Barlow J. Randomised controlled trial of a lay-led self-management programme for Bangladeshi patients with chronic disease. British Journal of General Practice 2005; 55: 831-837 Other publications of related interest Lorig K, Sobel D, Stewart A. Evidence suggesting that a chronic disease self-management program can improve health status while reducing hospitalisation: a randomized trial. Medical Care 1999;37(1): 5-14.
Lorig K R, Ritter P L, Gonzalez V M. Hispanic chronic disease self-management: a randomised community-based outcome trial. Nursing Research 2003;52(6):361-369.
Fu D, Fu H, McGowan P, et al. Implementation and quantitative evaluation of chronic disease self-management programme in Shanghai, China: randomised controlled trial. Bulletin of the World Health Organization 2003;81(3):174-182.
Indexing Status Subject indexing assigned by NLM MeSH Adult; Bangladesh /ethnology; Chronic Disease /psychology /therapy; Female; Humans; Male; Middle Aged; Patient Education as Topic /economics /standards; Patient Satisfaction; Program Evaluation; Quality of Life; Self Care /methods; Self Efficacy AccessionNumber 22006008032 Date bibliographic record published 31/05/2006 Date abstract record published 31/05/2006 |
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