Fluid Restriction and Quality of Life on Dialysis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Exploring the Effects of a Brief Values-Based Intervention on Adherence to Fluid Restriction Recommendations and Quality of Life in Haemodialysis Patients

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Behavioral: ACT Matrix


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single group study - multiple baseline case series
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACT Matrix<br>Participants will each receive the ACT Matrix intervention. Participants will be randomised to multiple start dates, producing different baseline durations. | Behavioral: ACT Matrix<br>* Participants will receive a 4 session psychological intervention based on the ACT Matrix<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dialysis Diet and Fluid Intake Non-Adherence Questionnaire (Vlamink et al., 2001) | 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). | baseline phase week 2 | 
| Dialysis Diet and Fluid Intake Non-Adherence Questionnaire (Vlamink et al., 2001) | 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). | baseline phase week 4 | 
| Dialysis Diet and Fluid Intake Non-Adherence Questionnaire (Vlamink et al., 2001) | 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). | baseline phase week 6 | 
| Dialysis Diet and Fluid Intake Non-Adherence Questionnaire (Vlamink et al., 2001) | 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). | baseline phase week 8 (those randomised to 8 and 10 week baselines only) | 
| Dialysis Diet and Fluid Intake Non-Adherence Questionnaire (Vlamink et al., 2001) | 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). | baseline phase week 10 (those randomised to 10 week baseline only) | 
| Dialysis Diet and Fluid Intake Non-Adherence Questionnaire (Vlamink et al., 2001) | 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). | intervention phase week 2 | 
| Dialysis Diet and Fluid Intake Non-Adherence Questionnaire (Vlamink et al., 2001) | 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). | intervention phase week 4 | 
| Dialysis Diet and Fluid Intake Non-Adherence Questionnaire (Vlamink et al., 2001) | 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). | 4 week (from end of intervention) follow-up | 
| Interdialytic weight gain | participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible. | Baseline phase week 1 | 
| Interdialytic weight gain | participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible. | Baseline phase week 2 | 
| Interdialytic weight gain | participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible. | Baseline phase week 3 | 
| Interdialytic weight gain | participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible. | Baseline phase week 4 | 
| Interdialytic weight gain | participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible. | Baseline phase week 5 | 
| Interdialytic weight gain | participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible. | Baseline phase week 6 | 
| Interdialytic weight gain | participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible. | Baseline phase week 7 (those randomised to 8 or 10 week follow-up) | 
| Interdialytic weight gain | participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible. | Baseline phase week 8 (those randomised to 8 or 10 week follow-up) | 
| Interdialytic weight gain | participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible. | Baseline phase week 9 (those randomised to 10 week baselines) | 
| Interdialytic weight gain | participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible. | Baseline phase week 10 (those randomised to 10 week baseline) | 
| Interdialytic weight gain | participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible. | intervention week 1 | 
| Interdialytic weight gain | participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible. | intervention week 2 | 
| Interdialytic weight gain | participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible. | intervention week 3 | 
| Interdialytic weight gain | participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible. | intervention week 4 | 
| Interdialytic weight gain | participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible. | four week follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Valuing Questionnaire | 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). | baseline week 1 | 
| Valuing Questionnaire | 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). | baseline week 2 | 
| Valuing Questionnaire | 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). | baseline week 3 | 
| Valuing Questionnaire | 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). | baseline week 4 | 
| Valuing Questionnaire | 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). | baseline week 5 | 
| Valuing Questionnaire | 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). | baseline week 6 | 
| Valuing Questionnaire | 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). | baseline week 7 (those randomised to 8 and 10 week baselines only) | 
| Valuing Questionnaire | 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). | baseline week 8 (those randomised to 8 and 10 week baselines only) | 
| Valuing Questionnaire | 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). | baseline week 9 (those randomised to 10 week baselines only) | 
| Valuing Questionnaire | 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). | baseline week 10 (those randomised to 10 week baselines only) |