Protocol for a pilot randomised controlled trial of an educational programme for adults on chronic haemodialysis with fatigue (Fatigue-HD)

Abstract

Introduction: Fatigue is a pervasive symptom of end-stage renal disease (ESRD) that is associated with low quality of life, disability and mortality, and has been identified as a top research priority by patients. We developed a personalised, web-supported educational programme (the Personal Energy Planning (PEP) programme) to teach people with ESRD to use energy management to manage fatigue. Preliminary studies have demonstrated positive effects on fatigue and life participation (ie, the ability to participate in valued day-to-day activities), which justifies the need for a randomised controlled trial (RCT) to better understand the efficacy of the programme. The objectives of the pilot RCT are to estimate RCT eligibility, recruitment and attrition rates, to inform the primary outcome measure and sample size for the RCT and to evaluate treatment fidelity among programme administrators.

Methods and analysis: A parallel-arm, 1:1 pilot RCT will be conducted at four in-centre haemodialysis units in Calgary, Alberta, Canada. People on haemodialysis who report moderate or severe fatigue on the Fatigue Severity Scale, and meet other study eligibility criteria, will be invited to participate. Consenting participants will be randomised to undergo the 7-9 week 'PEP' programme or an active control, and followed for 12 weeks after the programme concludes. Information on eligibility, recruitment and attrition rates will be collected, and questionnaires assessing fatigue and life participation will be administered preintervention, midintervention, immediately postintervention and 12 weeks postintervention. Analyses will include calculation of eligibility, recruitment and attrition rates; power considerations for the full-scale RCT and evaluation of treatment fidelity of programme administrators.

Ethics and dissemination: Risks associated with this study are minor. Patients may experience emotional discomfort while filling out study questionnaires. They will be advised to skip any questions that make them uncomfortable. Potential benefits of participating include any benefit derived from the study intervention, and contributing to research that may benefit people with kidney disease in the future. Trial results will be disseminated via publication in an academic journal and presentation at academic conferences. The study has been approved by the Conjoint Health Research Ethics Board at the University of Calgary (ID #18-1657).

Keywords: fatigue; randomised controlled trial; rehabilitation; renal dialysis; renal insufficiency, chronic.

Figure 1

Participant timeline. *Only if needed. Tx, assigned treatment session.