Supporting Fluid Restriction and Quality of Life on Dialysis
Research type
Research Study
Full title
Exploring the Effects of a Brief Values-Based Intervention on Adherence to Fluid Restriction Recommendations and Quality of Life in Haemodialysis Patients
IRAS ID
290048
Contact name
Catherine Crane
Contact email
Sponsor organisation
University of Oxford Clinical Trials and Research Governance
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Summary of Research
Almost 30,000 people in the UK receive dialysis due to end stage renal disease (ESRD). Although dialysis prolongs life, people receiving dialysis are still typically bothered by a range of physical symptoms and need to make substantial adjustments to their life in order to accommodate their condition and its treatment. One adjustment that is often required is a dramatic reduction in fluid intake. Although sticking to fluid intake restrictions improves the efficiency of dialysis, monitoring fluid intake is complicated. The restrictions also leave people feeling very thirsty so they can be hard to stick to. This project will develop and test a brief psychological intervention for people who struggle to adhere to fluid intake restrictions, and will aim to increase their quality of life whilst on dialysis. The intervention will be developed with input from people with lived experience of ESRD. It will then be offered to 12 people, recruited from clinics or community support groups, who will complete questionnaires to monitor their experiences and symptoms before, during and after the intervention. Their data will be analysed to find out whether the intervention has been helpful in increasing their quality of life and their ability to reduce their fluid intake in line with clinical recommendations. If the findings are promising, this would suggest that the intervention could be tested in a larger clinical study in the future.
Summary of Results
Study Context: This study explored the feasibility, acceptability and initial outcomes of a four-session psychological intervention for people experiencing difficulties with fluid restriction on dialysis. The study was developed with input from four people with lived experience of kidney disease and dialysis. These people reviewed study documents and discussed issues relating to the planned delivery of the intervention within renal units. The study received ethical approval from the Leicester South Research Ethics Committee and was sponsored by the University of Oxford. The study was registered at https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.clinicaltrials.gov%2F&data=05%7C01%7Capprovals%40hra.nhs.uk%7Cf6efb8685cac410be5fb08daf328968d%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638089652888632899%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=CI0ixDNsVfiTUJViqMdsygFHHKCAi8wfXg9DG2EhCs4%3D&reserved=0 (ref: NCT05264220). Participants were recruited from two haemodialysis units operated by Oxford University Hospitals NHS Trust. We are extremely grateful to our participants and lay advisers for their contribution to this project and to renal unit staff for their support with recruitment.
Background: Fluid restriction during dialysis treatment is important because dialysis cannot completely replace the function of damaged kidneys. Fluid restriction limits the build-up of excess fluids within bodily tissues, reducing strain on organs such as the heart and lungs. However, many people struggle with this and other recommended dietary and lifestyle changes. This study used an intervention based on a paper and pencil tool called the ACT Matrix (see Polk, Schoendorrf, Webster & Olaz, 2016). The aim of the ACT matrix is to support people to clarify their values, both broadly and in relation to health and wellbeing, to become aware of internal obstacles to values-consistent behaviour and develop strategies to support them to act in ways that were more consistent with their values, even when internal or external factors make this challenging.
Methods: Eight people who clinical staff felt could benefit from support to manage fluid restriction were recruited and consented to take part in the case series. They were randomly allocated to a baseline of 6, 8 or 10 weeks and during this baseline period completed weekly questionnaires. At the end of the baseline, participants were offered four therapy sessions, one per week for four weeks. Sessions were offered by a trainee clinical psychologist under supervision of an experienced renal clinical psychologist. Participants completed further questionnaires during the intervention and at four weeks follow-up. Interdialytic weight gain data was obtained from medical records for the 12 weeks prior to the start of the self-report baseline phase, and for the duration of the study to the end of follow-up with participant consent. Participants were also asked to provide feedback on the intervention at the final data collection point.
Results: Of the eight people who participated in the case series, seven received at least one intervention session and three completed the full study including four-week follow-up. Six participants experienced at least one inpatient admission during their period of involvement in the study. One participant was withdrawn by the clinical team during the baseline due to serious illness and two withdrew from self-report aspects of the study during the intervention because of acute health problems. One participant died of complications of ESRD during the follow-up period. None of these events were related to study procedures, but they illustrate the feasibility challenges of offering an intervention to improve fluid restriction in this clinical group.
Analysis of data related to intervention acceptability suggested that participants had moderate expectations of intervention success and those who completed the intervention viewed it positively, particularly commenting on the benefits of talking to someone who was independent of family and could help them look at issues from a different perspective. There was tentative evidence of some isolated improvements in study participants. For example, one participant showed improvement subjective fluid restriction, four showed improvements in interdialytic weight gain and three reported living more in line with what mattered to them. However, the combination of poor data quality, the small absolute magnitude of changes observed and co-occurring medical events that may have influenced fluid restriction, mean that confidence in the findings is severely compromised. Two participants showed statistically reliable improvements in psychological distress. Some participants reported that completing study measures burdensome whilst one said they found the measures a useful tool for reflection. There was no evidence of change in psychological processes thought to be cultivated by the therapeutic approach.
Discussion: This study has highlighted the challenges of managing the demands of dialysis alongside other related health problems. Although some people appeared to experience benefits from the intervention, these were very modest, and it is unclear whether the benefits observed would have exceeded those achieved through simple social support. Our data suggest that any intervention offered to support people with fluid restriction on dialysis needs to be flexible enough to accommodate interruptions and to be respectful of the fact that as a person’s health status changes, fluid control may need to be de-prioritised whilst they focus on other issues. If the intervention was to be trialled again it is suggested that it be offered people who are experiencing a period of relative stability in any concurrent health problems and are keen to use this period to work actively towards increased fluid control. Sessions occurring over a longer duration, alongside the provision of tapered follow-up, might also be required to enable people to establish and maintain challenging behavioural changes.
Dissemination: These findings of the study will be disseminated to participants, clinical staff within participating renal units and to the organisations whose members contributed to the initial development of the study. We will consider whether the findings are appropriate for presentation at a conference or submission to a peer review journal at this stage, or whether they are best regarded as pilot data used to inform ongoing clinical and research activity.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
21/EM/0025
Date of REC Opinion
23 Feb 2021
REC opinion
Further Information Favourable Opinion