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| A pilot randomised controlled trial of an energy management programme for adults on maintenance haemodialysis: the fatigue-HD study [with consumer summary] |
| Farragher JF, Ravani P, Manns B, Elliott M, Thomas C, Donald M, Verdin N, Hemmelgarn BR |
| BMJ Open 2022 Feb;12(2):e051475 |
| clinical trial |
| 6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
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BACKGROUND: Identifying interventions to reduce fatigue and improve life participation are top research priorities of people on maintenance haemodialysis. OBJECTIVE: Our primary objective was to explore the feasibility of conducting a randomised controlled trial of an energy management programme for people on maintenance haemodialysis. DESIGN: Parallel-arm, 1:1, blinded, pilot randomised controlled trial. PARTICIPANTS: Participants were recruited from 6 dialysis units in Calgary, Canada. Eligible patients were on maintenance haemodialysis, clinically stable and reported disabling fatigue on the Fatigue Severity Scale items 5, 7, 8 and 9. RANDOMISATION: Participants were randomised using a computer-generated random number sequence according to permuted blocked randomisation, stratified by dialysis unit. BLINDING: Participants were blinded to treatment allocation. INTERVENTIONS: Participants received an attention control (general disease self-management education) or the Personal Energy Planning (PEP) programme, a tailored, web-supported 7 to 9 weeks energy management programme. OUTCOMES: Eligibility, recruitment and attrition rates were recorded, and standardised intervention effects (Hedge's G) were calculated for fatigue and life participation questionnaires at 1-week postintervention and 12-week postintervention. RESULTS: 159 of 253 screened patients were eligible to be approached. 42 (26%) had fatigue, were interested and consented to participate, of whom 30 met eligibility criteria and were randomised (mean age 62.4 years (+/- 14.7), 60% male). 22 enrolled participants (73%) completed all study procedures. Medium-sized intervention effects were observed on the Canadian Occupational Performance Measure (COPM)-Performance Scale, Global Life Participation Scale and Global Life Participation Satisfaction Scale at 1-week postintervention follow-up, compared with control. At 12-week follow-up, large and very large intervention effects were observed on the COPM-Performance Scale and COPM-Satisfaction Scale, respectively. CONCLUSION: It is feasible to enrol and follow patients on haemodialysis in a randomised controlled trial of an energy management intervention. As the intervention was associated with improved life participation on some measures, a larger trial is justified.
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