Fluid Restriction and Quality of Life on Dialysis

University of Oxford

Status: Completed

Conditions: End Stage Renal Disease

Treatments: Behavioral: ACT Matrix

Study type: Interventional

Funder types: Other

Identifiers

NCT05264220

PID15290

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

ACT Matrix

Experimental group

Description:

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

Treatment:

Behavioral: ACT Matrix