Efficacy of nurse-led interventions on dialysis-related diet and fluid non-adherence and morbidities: protocol for a randomized controlled trial

Abstract

# Background Hemodialysis is the most sought after modality of treatment in patients with end stage renal disease. The success of hemodialysis depends on patient's adherence to diet and fluid restrictions to a great extent. The study aimed to examine the efficacy of nurse-led-interventions on dialysis related diet and fluid non-adherence and morbidities. # Methods The study will adopt quantitative approach and the design will be a parallel arm block randomized controlled trial with 6^th^ & 10^th^ week follow-ups. Hemodialysis patients, who fulfill inclusion and exclusion criteria, will be enrolled for the study as study participants. Baseline data will be collected after screening the participants and they will be randomized into an experimental or control group. The experimental group will receive nurse led interventions and the control group receives the standardized care. Participants will be randomized using sequentially numbered opaque sealed envelopes (SNOSE) according to computer-generated random order. Block randomization using randomly varying block sizes ensure equal numbers of subjects in each group with 1:1 allocation ratio. Primary outcomes are self-reported adherence and biochemical markers of adherence. An independent assessor will measure the endpoints at baseline and at 6^th^ and 10^th^ week after the intervention. # Conclusions This theory based Nurse led intervention trial designed based on vigorous review of previous research emphasizing the importance of nurse specific interventions to empower patients and enable them to be adherent with their treatment regimen. Inclusion of both subjective and objective measures of adherence will enhance the vigor of this trial and allows evaluating the extensive impact on the intervention including both hard end points as well as patient reported outcomes. If the nurse led intervention is found to be effective, this cost effective potential program can be implemented in all dialysis centers by giving dialysis specific and psychologically imbued training to all dialysis nurses of our country that will really cater the needs of dialysis patients. # Trial Registration Number CTRI/2019/06/019894