None listed
Conditions
Brief summary
The aim of the study is to evaluate the feasibility and acceptability of conducting a pragmatic cluster randomised trial of an intervention to improve health literacy, self-management and fluid adherence in people receiving haemodialysis in Sri Lanka.This is a two-arm pragmatic cluster randomised controlled trial with 1:1 allocation with a 12-week intervention duration. Participants assigned to the intervention group will receive both the standard care plus the intervention, while participants randomised to the control group will receive standard care provided by healthcare providers. Primary outcomes (feasibility and acceptability) will be measured at 12 weeks. Both objective and patient-reported measures are used to assess secondary outcomes. Subjective outcomes (knowledge on fluid and salt control in kidney failure, self-efficacy, self-care index of kidney failure, self-efficacy for managing chronic disease, health-related quality of life, health literacy) will be collected at baseline and at 12 weeks. Objective outcomes (blood pressure and interdialytic weight) will be measured at baseline will be measured at baseline and every week throughout the intervention period.
Interventions
The self-management intervention involves four face-to-face individual teach-back sessions of 30-40 minutes over a 12-week period using a written education booklet (My guide for salt and fluid for kidney health). A nurse will talk through a section of the education booklet and ask an individual to explain in their own words, what the healthcare professional has taught them. If the learner is unable to communicate the information that has been provided, the information provider repeats the inform
The self-management intervention involves four face-to-face individual teach-back sessions of 30-40 minutes over a 12-week period using a written education booklet (My guide for salt and fluid for kidney health). A nurse will talk through a section of the education booklet and ask an individual to explain in their own words, what the healthcare professional has taught them. If the learner is unable to communicate the information that has been provided, the information provider repeats the information until understanding is achieved. Use of teach-back in self-management teaching enhances the development of progressive achievement and independence through verbal persuasion as feedback is immediate. The booklet explains understanding kidney failure, overview of haemodialysis treatment, importance of fluid and sodium management, tips to control thirst, healthy foods to eat, meal planning and cooking tips, reading food labels, and what to do in social events. Additionally, supplementary documents includes patient stories, healthy foods to eat, sample meal plan, sample grocery list, curry powder recipies, low salt recipes, remedies to manage symptoms at home, and misperception about salt reduction. The written education booklet and supplementary documents have been developed by the research team, which has experts in the field of renal care and chronic disease self-management. In addition, a “fluid pack” including a bathroom scale to measure weight, measuring cup, spoon to measure the amount of liquid they are drinking, will be provided. Educational sessions are provided during routine haemodialysis treatment by a registered nurse in week 1, 3, 5 of the intervention, followed by one booster session at week 9. Participants in this intervention arm will receive both the standard care plus the intervention. Standard care involves a brief face-to-face 10 minutes education session that pertains to vascular access care, lifestyle modification, drug management, dietary and fluid restriction by a nursing officer after each HD treatment session.
Sponsors
Griffith University (School of Nursing and Midwifery)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults (18 years of age and over) with kidney failure undergoing HD treatment (a minimum of one time per week) for at least 3 months.
Exclusion criteria
Those on peritoneal dialysis, unable to speak and understand Sinhala, unable to provide informed consent, have a mental health condition, and/or impaired cognitive status that prevents the understanding of information, and people who are undergoing temporary HD for acute kidney injury.
Outcome results
None listed