The iPAD study protocol: rationale, design and baseline characteristics of a randomised controlled trial of patient activation interventions for adults receiving chronic hemodialysis

BackgroundPatient activation, defined as the knowledge, skills, and confidence to manage ones health, is associated with better outcomes in chronic disease. However, evidence on interventions that improve activation in people with end-stage kidney disease on hemodialysis remains limited. Methods and analysisThis single-centre, prospective, participant-blinded, randomised controlled trial conducted with adults undergoing chronic hemodialysis in an acute dialysis unit tests the hypothesis that adding tailored activation interventions to usual care improves patient activation and reduces complications in hemodialysis patients compared to usual care alone. A target sample size of 140 patients was recruited and randomised to iPAD interventions or usual care in a 1:1 ratio with an expected intervention period of at least 6 months. The primary outcome of iPAD was change in patient activation from baseline to 18 months. Ethics and disseminationThis study has been approved by all institutional ethics review boards involved in the study. Participants could only be enrolled following informed written consent. Results will be published in peer-reviewed journals and presented at scientific and clinical conferences. ConclusionRecruitment and enrolment targets were successfully achieved, with the cohort broadly representative of the dialysis population, including strong participation from culturally and linguistically diverse and socioeconomically disadvantaged groups. The careful planning and successful execution of the study in resource-constrained environments highlight its feasibility and flexibility, establishing it as a scalable and cost-efficient model for broad implementation in dialysis care globally.