Rationale, design and baseline characteristics of a randomised controlled trial of Interventions to support Patient Activation for adults on hemoDialysis: the IPAD study protocol.

backgroundPatient activation, defined as the knowledge, skills, and confidence to manage one’s health, is associated with better outcomes in chronic disease. However, evidence on interventions that improve activation in people with kidney failure on hemodialysis remains limited. METHODS AND ANALYSIS: This single-centre, prospective, randomised controlled trial conducted with adults undergoing long-term 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. STUDY PROGRESS: Recruitment has been completed, with 140 participants enrolled out of 147 individuals screened. The study cohort had a mean age of 58.4 ± 14.8 years and was predominantly male (72.1%, n = 101). The leading cause of kidney failure was diabetes (41.4%, n = 58), followed by IgA nephropathy (15%, n = 21) and hypertension (7.9%, n = 11). Comorbidity burden was substantial, with 55.7% (n = 78) of participants classified as severe. The mean Patient Activation Measure (PAM) score was 61.9 (± 15.0), reflecting moderate levels of engagement in self-management at the start of the study. Of 147 individuals screened, 140 were enrolled in the study.

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.