Fluid Restriction and Quality of Life on Dialysis

Not Applicable

Completed

• Conditions: End Stage Renal Disease
• Interventions: Behavioral: ACT Matrix

• Registration Number: NCT05264220
• Lead Sponsor: University of Oxford

Brief Summary

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 in order to accommodate ESRD 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 restrictions 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 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, who will complete questionnaires to monitor experiences and symptoms before, during and after the intervention. Participants' data will be analysed to find out whether the intervention has been helpful in reducing fluid intake and improving quality of life. If the findings are promising, this would suggest that the intervention could be tested in a larger clinical study in the future.

Detailed Description

Please note: this study adopts a between-subjects concurrent multiple baseline single case ABC experimental design. Participant change within and across phases A (baseline, variable with participants randomised to a 6, 8, or 10 week baseline), B (4 week intervention phase) and C (4 week follow-up) will be explored.

Study Timeline

• Status Verified: 2022-01
• Study First Submitted: 2022-01-13
• Study First Submitted QC: 2022-02-21
• Study First Posted: 2022-03-03
• Study Start: 2022-03-15
• Primary Completion: 2022-10-15
• Study Completion: 2022-10-15
• Last Update Submitted: 2022-12-07
• Last Update Posted: 2022-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Currently receiving haemodialysis for end-stage kidney disease
• Aged 18+
• Adequate fluency in written and spoken English to undertake the intervention and complete measures (assessed by research psychologist during discussion of study commitment)
• Willing and able to participate in face-to-face and/or digital delivery of a psychological intervention (e.g. if digital delivery is requested or/or necessitated by Covid 19 restrictions patient has access to a computer, tablet or phone).
• Identified by clinical staff as having difficulty with adherence to fluid intake recommendations.
• Consents to participation, including recording of video sessions for fidelity/adherence rating and supervision.

Exclusion Criteria

• • Lack of capacity to consent

  • Poorly controlled diabetes resulting in recent hospital admissions for hypo/hyperglycaemic episode(s)
  • Intellectual disability that prevents self-management of fluid intake

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ACT Matrix	ACT Matrix	Participants will each receive the ACT Matrix intervention. Participants will be randomised to multiple start dates, producing different baseline durations.

Primary Outcome Measures

Name	Time	Method
Interdialytic weight gain	four week follow-up	participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Dialysis Diet and Fluid Intake Non-Adherence Questionnaire (Vlamink et al., 2001)	4 week (from end of intervention) follow-up	This brief four-item measure assesses adherence to diet and fluid requirements over the previous 14 days. It includes the following items: 1) On how many days during the last 14 didn't you follow your diet guidelines? 2) To what degree did you deviate from your diet guidelines? (0-no deviation to 4 - very severe deviation) 3) On how many days during the last 14 didn't you follow your fluid guidelines? 4) To what degree did you deviate from your fluid guidelines? (0-no deviation to 4 - very severe deviation).

Secondary Outcome Measures

Name	Time	Method
Valuing Questionnaire	baseline week 10 (those randomised to 10 week baselines only)	This 10-item questionnaire assesses wellbeing as it relates to a person's ability to live the kind of life they value. It is designed for weekly administration. Items include statements such as "I made progress in the areas of life I care most about" and "my behaviour was a good example of what I stand for in life". Each item is rated on a scale ranging from 1 (not at all true) to 7 (completely true).

Trial Locations

Locations (1)

Renal and Transplant Medicine Unit (and satellite units), Oxford University Hospitals NHS Foundation Trust; 🇬🇧 Oxford, Oxfordshire, United Kingdom