Clinical trial NCT05264220: 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
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Oxford University Hospitals NHS Trust
name: Oxford Health NHS Foundation Trust
First posted: 2022-03-03
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group study - multiple baseline case series
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Dialysis Diet and Fluid Intake Non-Adherence Questionnaire (Vlamink et al., 2001)
timeFrame: baseline phase week 2
measure: Dialysis Diet and Fluid Intake Non-Adherence Questionnaire (Vlamink et al., 2001)
timeFrame: baseline phase week 4
measure: Dialysis Diet and Fluid Intake Non-Adherence Questionnaire (Vlamink et al., 2001)
timeFrame: baseline phase week 6
measure: Dialysis Diet and Fluid Intake Non-Adherence Questionnaire (Vlamink et al., 2001)
timeFrame: baseline phase week 8 (those randomised to 8 and 10 week baselines only)
measure: Dialysis Diet and Fluid Intake Non-Adherence Questionnaire (Vlamink et al., 2001)
timeFrame: baseline phase week 10 (those randomised to 10 week baseline only)
measure: Dialysis Diet and Fluid Intake Non-Adherence Questionnaire (Vlamink et al., 2001)
timeFrame: intervention phase week 2
measure: Dialysis Diet and Fluid Intake Non-Adherence Questionnaire (Vlamink et al., 2001)
timeFrame: intervention phase week 4
measure: Dialysis Diet and Fluid Intake Non-Adherence Questionnaire (Vlamink et al., 2001)
timeFrame: 4 week (from end of intervention) follow-up
measure: Interdialytic weight gain
timeFrame: Baseline phase week 1
measure: Interdialytic weight gain
timeFrame: Baseline phase week 2
measure: Interdialytic weight gain
timeFrame: Baseline phase week 3
measure: Interdialytic weight gain
timeFrame: Baseline phase week 4
measure: Interdialytic weight gain
timeFrame: Baseline phase week 5
measure: Interdialytic weight gain
timeFrame: Baseline phase week 6
measure: Interdialytic weight gain
timeFrame: Baseline phase week 7 (those randomised to 8 or 10 week follow-up)
measure: Interdialytic weight gain
timeFrame: Baseline phase week 8 (those randomised to 8 or 10 week follow-up)
measure: Interdialytic weight gain
timeFrame: Baseline phase week 9 (those randomised to 10 week baselines)
measure: Interdialytic weight gain
timeFrame: Baseline phase week 10 (those randomised to 10 week baseline)
measure: Interdialytic weight gain
timeFrame: intervention week 1
measure: Interdialytic weight gain
timeFrame: intervention week 2
measure: Interdialytic weight gain
timeFrame: intervention week 3
measure: Interdialytic weight gain
timeFrame: intervention week 4
measure: Interdialytic weight gain
timeFrame: four week follow-up
Secondary outcomes:
measure: Valuing Questionnaire
timeFrame: baseline week 1
measure: Valuing Questionnaire
timeFrame: baseline week 2
measure: Valuing Questionnaire
timeFrame: baseline week 3
measure: Valuing Questionnaire
timeFrame: baseline week 4
measure: Valuing Questionnaire
timeFrame: baseline week 5
measure: Valuing Questionnaire
timeFrame: baseline week 6
measure: Valuing Questionnaire
timeFrame: baseline week 7 (those randomised to 8 and 10 week baselines only)
measure: Valuing Questionnaire
timeFrame: baseline week 8 (those randomised to 8 and 10 week baselines only)
measure: Valuing Questionnaire
timeFrame: baseline week 9 (those randomised to 10 week baselines only)
measure: Valuing Questionnaire
timeFrame: baseline week 10 (those randomised to 10 week baselines only)
Other outcomes:
measure: End-Stage Renal Disease Adherence Questionnaire (ESRD-AQ; Kim et al., 2010)
timeFrame: Study intake assessment
measure: The Clinical Outcomes Routine Evaluation (CORE) -10 (Barkham et al., 2013)
timeFrame: Baseline week 1
measure: The Clinical Outcomes Routine Evaluation (CORE) -10 (Barkham et al., 2013)
timeFrame: intervention week 1
measure: The Clinical Outcomes Routine Evaluation (CORE) -10 (Barkham et al., 2013)
timeFrame: intervention week 4
measure: The Clinical Outcomes Routine Evaluation (CORE) -10 (Barkham et al., 2013)
timeFrame: Four week follow-up
measure: EQ-5D-5L (EuroQuol Group, 2009).
timeFrame: Baseline phase week 1
measure: EQ-5D-5L (EuroQuol Group, 2009).
timeFrame: Intervention week 1
measure: EQ-5D-5L (EuroQuol Group, 2009).
timeFrame: Intervention week 4
measure: EQ-5D-5L (EuroQuol Group, 2009).
timeFrame: Four week follow-up
measure: Dialysis Symptoms Index (Weisbord et al., 2004)
timeFrame: Baseline week 1
measure: Dialysis Symptoms Index (Weisbord et al., 2004)
timeFrame: Intervention week 1
measure: Dialysis Symptoms Index (Weisbord et al., 2004)
timeFrame: Intervention week 4
measure: Dialysis Symptoms Index (Weisbord et al., 2004)
timeFrame: Four week follow-up
measure: CompACT (Francis, Dawson & Golijani-Moghaddam, 2016)
timeFrame: Baseline week 1
measure: CompACT (Francis, Dawson & Golijani-Moghaddam, 2016)
timeFrame: Intervention week 1
measure: CompACT (Francis, Dawson & Golijani-Moghaddam, 2016)
timeFrame: Intervention week 4
measure: CompACT (Francis, Dawson & Golijani-Moghaddam, 2016)
timeFrame: Four week follow-up
measure: Intervention Credibility/Expectancy Questionnaire (Devilly & Borkovec, 2000)
timeFrame: Intervention week 1
measure: Intervention Credibility/Expectancy Questionnaire (Devilly & Borkovec, 2000)
timeFrame: Four week follow-up
Locations:
city: Oxford
country: United Kingdom
facility: Renal and Transplant Medicine Unit (and satellite units), Oxford University Hospitals NHS Foundation Trust
state: Oxfordshire
Study officials:
affiliation: University of Oxford
name: Catherine H Crane, DPhil
role: PRINCIPAL_INVESTIGATOR
References: