Fluid Restriction and Quality of Life on Dialysis

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05264220
• Other study ID #: PID15290
• Status: Completed
• Phase: N/A
• Start date: March 15, 2022
• Est. completion date: October 15, 2022

Study information

• Verified date: January 2022
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: October 15, 2022
• Est. primary completion date: October 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Renal and Transplant Medicine Unit (and satellite units), Oxford University Hospitals NHS Foundation Trust	Oxford	Oxfordshire

Sponsors (3)

Lead Sponsor	Collaborator
University of Oxford	Oxford Health NHS Foundation Trust, Oxford University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	End-Stage Renal Disease Adherence Questionnaire (ESRD-AQ; Kim et al., 2010)	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.	Study intake assessment
Other	The Clinical Outcomes Routine Evaluation (CORE) -10 (Barkham et al., 2013)	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).	Baseline week 1
Other	The Clinical Outcomes Routine Evaluation (CORE) -10 (Barkham et al., 2013)	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).	intervention week 1
Other	The Clinical Outcomes Routine Evaluation (CORE) -10 (Barkham et al., 2013)	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).	intervention week 4
Other	The Clinical Outcomes Routine Evaluation (CORE) -10 (Barkham et al., 2013)	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).	Four week follow-up
Other	EQ-5D-5L (EuroQuol Group, 2009).	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.	Baseline phase week 1
Other	EQ-5D-5L (EuroQuol Group, 2009).	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.	Intervention week 1
Other	EQ-5D-5L (EuroQuol Group, 2009).	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.	Intervention week 4
Other	EQ-5D-5L (EuroQuol Group, 2009).	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.	Four week follow-up
Other	Dialysis Symptoms Index (Weisbord et al., 2004)	Measure of common physical and psychological symptoms experienced by people on dialysis	Baseline week 1
Other	Dialysis Symptoms Index (Weisbord et al., 2004)	Measure of common physical and psychological symptoms experienced by people on dialysis	Intervention week 1
Other	Dialysis Symptoms Index (Weisbord et al., 2004)	Measure of common physical and psychological symptoms experienced by people on dialysis	Intervention week 4
Other	Dialysis Symptoms Index (Weisbord et al., 2004)	Measure of common physical and psychological symptoms experienced by people on dialysis	Four week follow-up
Other	CompACT (Francis, Dawson & Golijani-Moghaddam, 2016)	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).	Baseline week 1
Other	CompACT (Francis, Dawson & Golijani-Moghaddam, 2016)	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).	Intervention week 1
Other	CompACT (Francis, Dawson & Golijani-Moghaddam, 2016)	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).	Intervention week 4
Other	CompACT (Francis, Dawson & Golijani-Moghaddam, 2016)	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).	Four week follow-up
Other	Intervention Credibility/Expectancy Questionnaire (Devilly & Borkovec, 2000)	measure of participants' views on intervention credibility	Intervention week 1
Other	Intervention Credibility/Expectancy Questionnaire (Devilly & Borkovec, 2000)	measure of participants' views on intervention credibility	Four week follow-up
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	Interdialytic weight gain	participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.	Baseline phase week 1
Primary	Interdialytic weight gain	participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.	Baseline phase week 2
Primary	Interdialytic weight gain	participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.	Baseline phase week 3
Primary	Interdialytic weight gain	participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.	Baseline phase week 4
Primary	Interdialytic weight gain	participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.	Baseline phase week 5
Primary	Interdialytic weight gain	participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.	Baseline phase week 6
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	Interdialytic weight gain	participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.	intervention week 1
Primary	Interdialytic weight gain	participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.	intervention week 2
Primary	Interdialytic weight gain	participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.	intervention week 3
Primary	Interdialytic weight gain	participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.	intervention week 4
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)