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NCT Number: NCT05264220

Fluid Restriction and Quality of Life on Dialysis

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.

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Key information

Conditions

End Stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Oxford, Oxfordshire, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACT Matrix

Behavioral

Participants will receive a 4 session psychological intervention based on the ACT Matrix

Primary outcomes

  1. Dialysis Diet and Fluid Intake Non-Adherence Questionnaire (Vlamink et al., 2001)

    Time frame: baseline phase week 2

    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).

  2. Dialysis Diet and Fluid Intake Non-Adherence Questionnaire (Vlamink et al., 2001)

    Time frame: baseline phase week 4

    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).

  3. Dialysis Diet and Fluid Intake Non-Adherence Questionnaire (Vlamink et al., 2001)

    Time frame: baseline phase week 6

    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. Dialysis Diet and Fluid Intake Non-Adherence Questionnaire (Vlamink et al., 2001)

    Time frame: baseline phase week 8 (those randomised to 8 and 10 week baselines only)

    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).

  5. Dialysis Diet and Fluid Intake Non-Adherence Questionnaire (Vlamink et al., 2001)

    Time frame: baseline phase week 10 (those randomised to 10 week baseline only)

    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).

  6. Dialysis Diet and Fluid Intake Non-Adherence Questionnaire (Vlamink et al., 2001)

    Time frame: intervention phase week 2

    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).

  7. Dialysis Diet and Fluid Intake Non-Adherence Questionnaire (Vlamink et al., 2001)

    Time frame: intervention phase week 4

    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).

  8. Dialysis Diet and Fluid Intake Non-Adherence Questionnaire (Vlamink et al., 2001)

    Time frame: 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).

  9. Interdialytic weight gain

    Time frame: Baseline phase week 1

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

  10. Interdialytic weight gain

    Time frame: Baseline phase week 2

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

  11. Interdialytic weight gain

    Time frame: Baseline phase week 3

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

  12. Interdialytic weight gain

    Time frame: Baseline phase week 4

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

  13. Interdialytic weight gain

    Time frame: Baseline phase week 5

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

  14. Interdialytic weight gain

    Time frame: Baseline phase week 6

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

  15. Interdialytic weight gain

    Time frame: Baseline phase week 7 (those randomised to 8 or 10 week follow-up)

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

  16. Interdialytic weight gain

    Time frame: Baseline phase week 8 (those randomised to 8 or 10 week follow-up)

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

  17. Interdialytic weight gain

    Time frame: Baseline phase week 9 (those randomised to 10 week baselines)

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

  18. Interdialytic weight gain

    Time frame: Baseline phase week 10 (those randomised to 10 week baseline)

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

  19. Interdialytic weight gain

    Time frame: intervention week 1

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

  20. Interdialytic weight gain

    Time frame: intervention week 2

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

  21. Interdialytic weight gain

    Time frame: intervention week 3

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

  22. Interdialytic weight gain

    Time frame: intervention week 4

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

  23. Interdialytic weight gain

    Time frame: four week follow-up

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

Secondary outcomes

  1. Valuing Questionnaire

    Time frame: baseline week 1

    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).

  2. Valuing Questionnaire

    Time frame: baseline week 2

    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).

  3. Valuing Questionnaire

    Time frame: baseline week 3

    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).

  4. Valuing Questionnaire

    Time frame: baseline week 4

    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).

  5. Valuing Questionnaire

    Time frame: baseline week 5

    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).

  6. Valuing Questionnaire

    Time frame: baseline week 6

    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).

  7. Valuing Questionnaire

    Time frame: baseline week 7 (those randomised to 8 and 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).

  8. Valuing Questionnaire

    Time frame: baseline week 8 (those randomised to 8 and 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).

  9. Valuing Questionnaire

    Time frame: baseline week 9 (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).

  10. Valuing Questionnaire

    Time frame: 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).

Other outcomes

  1. End-Stage Renal Disease Adherence Questionnaire (ESRD-AQ; Kim et al., 2010)

    Time frame: Study intake assessment

    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.

  2. The Clinical Outcomes Routine Evaluation (CORE) -10 (Barkham et al., 2013)

    Time frame: Baseline week 1

    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).

  3. The Clinical Outcomes Routine Evaluation (CORE) -10 (Barkham et al., 2013)

    Time frame: intervention week 1

    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).

  4. The Clinical Outcomes Routine Evaluation (CORE) -10 (Barkham et al., 2013)

    Time frame: intervention week 4

    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).

  5. The Clinical Outcomes Routine Evaluation (CORE) -10 (Barkham et al., 2013)

    Time frame: Four week follow-up

    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).

  6. EQ-5D-5L (EuroQuol Group, 2009).

    Time frame: Baseline phase week 1

    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.

  7. EQ-5D-5L (EuroQuol Group, 2009).

    Time frame: Intervention week 1

    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.

  8. EQ-5D-5L (EuroQuol Group, 2009).

    Time frame: Intervention week 4

    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.

  9. EQ-5D-5L (EuroQuol Group, 2009).

    Time frame: Four week follow-up

    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.

  10. Dialysis Symptoms Index (Weisbord et al., 2004)

    Time frame: Baseline week 1

    Measure of common physical and psychological symptoms experienced by people on dialysis

  11. Dialysis Symptoms Index (Weisbord et al., 2004)

    Time frame: Intervention week 1

    Measure of common physical and psychological symptoms experienced by people on dialysis

  12. Dialysis Symptoms Index (Weisbord et al., 2004)

    Time frame: Intervention week 4

    Measure of common physical and psychological symptoms experienced by people on dialysis

  13. Dialysis Symptoms Index (Weisbord et al., 2004)

    Time frame: Four week follow-up

    Measure of common physical and psychological symptoms experienced by people on dialysis

  14. CompACT (Francis, Dawson & Golijani-Moghaddam, 2016)

    Time frame: Baseline week 1

    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).

  15. CompACT (Francis, Dawson & Golijani-Moghaddam, 2016)

    Time frame: Intervention week 1

    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).

  16. CompACT (Francis, Dawson & Golijani-Moghaddam, 2016)

    Time frame: Intervention week 4

    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).

  17. CompACT (Francis, Dawson & Golijani-Moghaddam, 2016)

    Time frame: Four week follow-up

    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).

  18. Intervention Credibility/Expectancy Questionnaire (Devilly & Borkovec, 2000)

    Time frame: Intervention week 1

    measure of participants' views on intervention credibility

  19. Intervention Credibility/Expectancy Questionnaire (Devilly & Borkovec, 2000)

    Time frame: Four week follow-up

    measure of participants' views on intervention credibility

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • Oxford Health NHS Foundation Trust
  • Oxford University Hospitals NHS Trust

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 3, 2022
Registry last updated
Dec 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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