A pilot randomised controlled trial of an energy management programme for adults on maintenance haemodialysis: the fatigue-HD study

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 7-9 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 one1-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.

Automated summary

This study explored the feasibility of conducting a randomized controlled trial for an energy management program for people on maintenance hemodialysis. The results showed that the intervention was associated with improved life participation on some measures, justifying the need for a larger trial.