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Fluid Restriction and Quality of Life on Dialysis

Primary Purpose

End Stage Renal Disease

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
ACT Matrix
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Renal and Transplant Medicine Unit (and satellite units), Oxford University Hospitals NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ACT Matrix

Arm Description

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

Outcomes

Primary Outcome Measures

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).
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).
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).
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).
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).
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).
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).
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).
Interdialytic weight gain
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Interdialytic weight gain
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Interdialytic weight gain
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Interdialytic weight gain
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Interdialytic weight gain
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Interdialytic weight gain
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Interdialytic weight gain
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Interdialytic weight gain
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Interdialytic weight gain
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Interdialytic weight gain
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Interdialytic weight gain
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Interdialytic weight gain
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Interdialytic weight gain
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Interdialytic weight gain
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Interdialytic weight gain
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.

Secondary Outcome Measures

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).
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).
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).
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).
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).
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).
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).
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).
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).
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).

Full Information

First Posted
January 13, 2022
Last Updated
December 7, 2022
Sponsor
University of Oxford
Collaborators
Oxford University Hospitals NHS Trust, Oxford Health NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05264220
Brief Title
Fluid Restriction and Quality of Life on Dialysis
Official Title
Exploring the Effects of a Brief Values-Based Intervention on Adherence to Fluid Restriction Recommendations and Quality of Life in Haemodialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 15, 2022 (Actual)
Primary Completion Date
October 15, 2022 (Actual)
Study Completion Date
October 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford
Collaborators
Oxford University Hospitals NHS Trust, Oxford Health NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single group study - multiple baseline case series
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACT Matrix
Arm Type
Experimental
Arm Description
Participants will each receive the ACT Matrix intervention. Participants will be randomised to multiple start dates, producing different baseline durations.
Intervention Type
Behavioral
Intervention Name(s)
ACT Matrix
Intervention Description
Participants will receive a 4 session psychological intervention based on the ACT Matrix
Primary Outcome Measure Information:
Title
Dialysis Diet and Fluid Intake Non-Adherence Questionnaire (Vlamink et al., 2001)
Description
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).
Time Frame
baseline phase week 2
Title
Dialysis Diet and Fluid Intake Non-Adherence Questionnaire (Vlamink et al., 2001)
Description
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).
Time Frame
baseline phase week 4
Title
Dialysis Diet and Fluid Intake Non-Adherence Questionnaire (Vlamink et al., 2001)
Description
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).
Time Frame
baseline phase week 6
Title
Dialysis Diet and Fluid Intake Non-Adherence Questionnaire (Vlamink et al., 2001)
Description
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).
Time Frame
baseline phase week 8 (those randomised to 8 and 10 week baselines only)
Title
Dialysis Diet and Fluid Intake Non-Adherence Questionnaire (Vlamink et al., 2001)
Description
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).
Time Frame
baseline phase week 10 (those randomised to 10 week baseline only)
Title
Dialysis Diet and Fluid Intake Non-Adherence Questionnaire (Vlamink et al., 2001)
Description
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).
Time Frame
intervention phase week 2
Title
Dialysis Diet and Fluid Intake Non-Adherence Questionnaire (Vlamink et al., 2001)
Description
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).
Time Frame
intervention phase week 4
Title
Dialysis Diet and Fluid Intake Non-Adherence Questionnaire (Vlamink et al., 2001)
Description
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).
Time Frame
4 week (from end of intervention) follow-up
Title
Interdialytic weight gain
Description
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Time Frame
Baseline phase week 1
Title
Interdialytic weight gain
Description
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Time Frame
Baseline phase week 2
Title
Interdialytic weight gain
Description
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Time Frame
Baseline phase week 3
Title
Interdialytic weight gain
Description
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Time Frame
Baseline phase week 4
Title
Interdialytic weight gain
Description
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Time Frame
Baseline phase week 5
Title
Interdialytic weight gain
Description
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Time Frame
Baseline phase week 6
Title
Interdialytic weight gain
Description
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Time Frame
Baseline phase week 7 (those randomised to 8 or 10 week follow-up)
Title
Interdialytic weight gain
Description
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Time Frame
Baseline phase week 8 (those randomised to 8 or 10 week follow-up)
Title
Interdialytic weight gain
Description
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Time Frame
Baseline phase week 9 (those randomised to 10 week baselines)
Title
Interdialytic weight gain
Description
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Time Frame
Baseline phase week 10 (those randomised to 10 week baseline)
Title
Interdialytic weight gain
Description
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Time Frame
intervention week 1
Title
Interdialytic weight gain
Description
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Time Frame
intervention week 2
Title
Interdialytic weight gain
Description
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Time Frame
intervention week 3
Title
Interdialytic weight gain
Description
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Time Frame
intervention week 4
Title
Interdialytic weight gain
Description
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Time Frame
four week follow-up
Secondary Outcome Measure Information:
Title
Valuing Questionnaire
Description
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).
Time Frame
baseline week 1
Title
Valuing Questionnaire
Description
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).
Time Frame
baseline week 2
Title
Valuing Questionnaire
Description
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).
Time Frame
baseline week 3
Title
Valuing Questionnaire
Description
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).
Time Frame
baseline week 4
Title
Valuing Questionnaire
Description
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).
Time Frame
baseline week 5
Title
Valuing Questionnaire
Description
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).
Time Frame
baseline week 6
Title
Valuing Questionnaire
Description
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).
Time Frame
baseline week 7 (those randomised to 8 and 10 week baselines only)
Title
Valuing Questionnaire
Description
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).
Time Frame
baseline week 8 (those randomised to 8 and 10 week baselines only)
Title
Valuing Questionnaire
Description
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).
Time Frame
baseline week 9 (those randomised to 10 week baselines only)
Title
Valuing Questionnaire
Description
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).
Time Frame
baseline week 10 (those randomised to 10 week baselines only)
Other Pre-specified Outcome Measures:
Title
End-Stage Renal Disease Adherence Questionnaire (ESRD-AQ; Kim et al., 2010)
Description
This self-report measure includes 46 questions assessing adherence to medication, diet, fluid intake restrictions and participation in dialysis sessions. It has excellent psychometric properties.
Time Frame
Study intake assessment
Title
The Clinical Outcomes Routine Evaluation (CORE) -10 (Barkham et al., 2013)
Description
This measure assesses severity of clinical symptoms, across 10 items, each rated 0-4. The measure differentiates clinical samples from non-clinical populations. It has adequate convergent validity when correlated with other clinical measures, and good internal reliability (Cronbach's alpha > .80) and sensitivity to change (see Connell & Barkham, 2007). A change on the CORE-10 of six or more points corresponds to statistically reliable change. Scores on the measure are interpreted as follows: 0-5 (healthy); 6-10 (low level); 11-15 (mild); 16-20 (moderate); 21-25 (moderately severe); 26 + (severe).
Time Frame
Baseline week 1
Title
The Clinical Outcomes Routine Evaluation (CORE) -10 (Barkham et al., 2013)
Description
This measure assesses severity of clinical symptoms, across 10 items, each rated 0-4. The measure differentiates clinical samples from non-clinical populations. It has adequate convergent validity when correlated with other clinical measures, and good internal reliability (Cronbach's alpha > .80) and sensitivity to change (see Connell & Barkham, 2007). A change on the CORE-10 of six or more points corresponds to statistically reliable change. Scores on the measure are interpreted as follows: 0-5 (healthy); 6-10 (low level); 11-15 (mild); 16-20 (moderate); 21-25 (moderately severe); 26 + (severe).
Time Frame
intervention week 1
Title
The Clinical Outcomes Routine Evaluation (CORE) -10 (Barkham et al., 2013)
Description
This measure assesses severity of clinical symptoms, across 10 items, each rated 0-4. The measure differentiates clinical samples from non-clinical populations. It has adequate convergent validity when correlated with other clinical measures, and good internal reliability (Cronbach's alpha > .80) and sensitivity to change (see Connell & Barkham, 2007). A change on the CORE-10 of six or more points corresponds to statistically reliable change. Scores on the measure are interpreted as follows: 0-5 (healthy); 6-10 (low level); 11-15 (mild); 16-20 (moderate); 21-25 (moderately severe); 26 + (severe).
Time Frame
intervention week 4
Title
The Clinical Outcomes Routine Evaluation (CORE) -10 (Barkham et al., 2013)
Description
This measure assesses severity of clinical symptoms, across 10 items, each rated 0-4. The measure differentiates clinical samples from non-clinical populations. It has adequate convergent validity when correlated with other clinical measures, and good internal reliability (Cronbach's alpha > .80) and sensitivity to change (see Connell & Barkham, 2007). A change on the CORE-10 of six or more points corresponds to statistically reliable change. Scores on the measure are interpreted as follows: 0-5 (healthy); 6-10 (low level); 11-15 (mild); 16-20 (moderate); 21-25 (moderately severe); 26 + (severe).
Time Frame
Four week follow-up
Title
EQ-5D-5L (EuroQuol Group, 2009).
Description
This widely used measure assesses quality of life across five domains: mobility, self-care, usual activities, pain / discomfort, anxiety/depression. Each domain is rated on a five-level scale: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. Additionally, respondents complete a health thermometer rating their current health status on a scale from 0 to 100. The EQ-5D-5L is a widely used measure for assessing health status with normative data available for UK samples.
Time Frame
Baseline phase week 1
Title
EQ-5D-5L (EuroQuol Group, 2009).
Description
This widely used measure assesses quality of life across five domains: mobility, self-care, usual activities, pain / discomfort, anxiety/depression. Each domain is rated on a five-level scale: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. Additionally, respondents complete a health thermometer rating their current health status on a scale from 0 to 100. The EQ-5D-5L is a widely used measure for assessing health status with normative data available for UK samples.
Time Frame
Intervention week 1
Title
EQ-5D-5L (EuroQuol Group, 2009).
Description
This widely used measure assesses quality of life across five domains: mobility, self-care, usual activities, pain / discomfort, anxiety/depression. Each domain is rated on a five-level scale: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. Additionally, respondents complete a health thermometer rating their current health status on a scale from 0 to 100. The EQ-5D-5L is a widely used measure for assessing health status with normative data available for UK samples.
Time Frame
Intervention week 4
Title
EQ-5D-5L (EuroQuol Group, 2009).
Description
This widely used measure assesses quality of life across five domains: mobility, self-care, usual activities, pain / discomfort, anxiety/depression. Each domain is rated on a five-level scale: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. Additionally, respondents complete a health thermometer rating their current health status on a scale from 0 to 100. The EQ-5D-5L is a widely used measure for assessing health status with normative data available for UK samples.
Time Frame
Four week follow-up
Title
Dialysis Symptoms Index (Weisbord et al., 2004)
Description
Measure of common physical and psychological symptoms experienced by people on dialysis
Time Frame
Baseline week 1
Title
Dialysis Symptoms Index (Weisbord et al., 2004)
Description
Measure of common physical and psychological symptoms experienced by people on dialysis
Time Frame
Intervention week 1
Title
Dialysis Symptoms Index (Weisbord et al., 2004)
Description
Measure of common physical and psychological symptoms experienced by people on dialysis
Time Frame
Intervention week 4
Title
Dialysis Symptoms Index (Weisbord et al., 2004)
Description
Measure of common physical and psychological symptoms experienced by people on dialysis
Time Frame
Four week follow-up
Title
CompACT (Francis, Dawson & Golijani-Moghaddam, 2016)
Description
This 23-item questionnaire assesses psychological flexibility. In addition to a total score, three subscale scores reflecting openness to experience, behavioural awareness and valued action can be derived. Each item is rated on a scale ranging from 0 (strongly disagree) to 6 (strongly agree).
Time Frame
Baseline week 1
Title
CompACT (Francis, Dawson & Golijani-Moghaddam, 2016)
Description
This 23-item questionnaire assesses psychological flexibility. In addition to a total score, three subscale scores reflecting openness to experience, behavioural awareness and valued action can be derived. Each item is rated on a scale ranging from 0 (strongly disagree) to 6 (strongly agree).
Time Frame
Intervention week 1
Title
CompACT (Francis, Dawson & Golijani-Moghaddam, 2016)
Description
This 23-item questionnaire assesses psychological flexibility. In addition to a total score, three subscale scores reflecting openness to experience, behavioural awareness and valued action can be derived. Each item is rated on a scale ranging from 0 (strongly disagree) to 6 (strongly agree).
Time Frame
Intervention week 4
Title
CompACT (Francis, Dawson & Golijani-Moghaddam, 2016)
Description
This 23-item questionnaire assesses psychological flexibility. In addition to a total score, three subscale scores reflecting openness to experience, behavioural awareness and valued action can be derived. Each item is rated on a scale ranging from 0 (strongly disagree) to 6 (strongly agree).
Time Frame
Four week follow-up
Title
Intervention Credibility/Expectancy Questionnaire (Devilly & Borkovec, 2000)
Description
measure of participants' views on intervention credibility
Time Frame
Intervention week 1
Title
Intervention Credibility/Expectancy Questionnaire (Devilly & Borkovec, 2000)
Description
measure of participants' views on intervention credibility
Time Frame
Four week follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine H Crane, DPhil
Organizational Affiliation
University of Oxford
Official's Role
Principal Investigator
Facility Information:
Facility Name
Renal and Transplant Medicine Unit (and satellite units), Oxford University Hospitals NHS Foundation Trust
City
Oxford
State/Province
Oxfordshire
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Fluid Restriction and Quality of Life on Dialysis

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