Fluid Restriction and Quality of Life on Dialysis

NCT05264220 | Completed

• 1 other identifier: PID15290
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (23)

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

  This brief four-item measure assesses adherence to diet and fluid requirements over the previous 14 days. It includes the following items: 1) On how many days during the last 14 didn't you follow your diet guidelines? 2) To what degree did you deviate from your diet guidelines? (0-no deviation to 4 - very severe deviation) 3) On how many days during the last 14 didn't you follow your fluid guidelines? 4) To what degree did you deviate from your fluid guidelines? (0-no deviation to 4 - very severe deviation).

  baseline phase week 2

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

  This brief four-item measure assesses adherence to diet and fluid requirements over the previous 14 days. It includes the following items: 1) On how many days during the last 14 didn't you follow your diet guidelines? 2) To what degree did you deviate from your diet guidelines? (0-no deviation to 4 - very severe deviation) 3) On how many days during the last 14 didn't you follow your fluid guidelines? 4) To what degree did you deviate from your fluid guidelines? (0-no deviation to 4 - very severe deviation).

  baseline phase week 4

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

  This brief four-item measure assesses adherence to diet and fluid requirements over the previous 14 days. It includes the following items: 1) On how many days during the last 14 didn't you follow your diet guidelines? 2) To what degree did you deviate from your diet guidelines? (0-no deviation to 4 - very severe deviation) 3) On how many days during the last 14 didn't you follow your fluid guidelines? 4) To what degree did you deviate from your fluid guidelines? (0-no deviation to 4 - very severe deviation).

  baseline phase week 6

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

  This brief four-item measure assesses adherence to diet and fluid requirements over the previous 14 days. It includes the following items: 1) On how many days during the last 14 didn't you follow your diet guidelines? 2) To what degree did you deviate from your diet guidelines? (0-no deviation to 4 - very severe deviation) 3) On how many days during the last 14 didn't you follow your fluid guidelines? 4) To what degree did you deviate from your fluid guidelines? (0-no deviation to 4 - very severe deviation).

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

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

  This brief four-item measure assesses adherence to diet and fluid requirements over the previous 14 days. It includes the following items: 1) On how many days during the last 14 didn't you follow your diet guidelines? 2) To what degree did you deviate from your diet guidelines? (0-no deviation to 4 - very severe deviation) 3) On how many days during the last 14 didn't you follow your fluid guidelines? 4) To what degree did you deviate from your fluid guidelines? (0-no deviation to 4 - very severe deviation).

  baseline phase week 10 (those randomised to 10 week baseline only)

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

  This brief four-item measure assesses adherence to diet and fluid requirements over the previous 14 days. It includes the following items: 1) On how many days during the last 14 didn't you follow your diet guidelines? 2) To what degree did you deviate from your diet guidelines? (0-no deviation to 4 - very severe deviation) 3) On how many days during the last 14 didn't you follow your fluid guidelines? 4) To what degree did you deviate from your fluid guidelines? (0-no deviation to 4 - very severe deviation).

  intervention phase week 2

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

  This brief four-item measure assesses adherence to diet and fluid requirements over the previous 14 days. It includes the following items: 1) On how many days during the last 14 didn't you follow your diet guidelines? 2) To what degree did you deviate from your diet guidelines? (0-no deviation to 4 - very severe deviation) 3) On how many days during the last 14 didn't you follow your fluid guidelines? 4) To what degree did you deviate from your fluid guidelines? (0-no deviation to 4 - very severe deviation).

  intervention phase week 4

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

  This brief four-item measure assesses adherence to diet and fluid requirements over the previous 14 days. It includes the following items: 1) On how many days during the last 14 didn't you follow your diet guidelines? 2) To what degree did you deviate from your diet guidelines? (0-no deviation to 4 - very severe deviation) 3) On how many days during the last 14 didn't you follow your fluid guidelines? 4) To what degree did you deviate from your fluid guidelines? (0-no deviation to 4 - very severe deviation).

  4 week (from end of intervention) follow-up

• Interdialytic weight gain

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

  Baseline phase week 1

• Interdialytic weight gain

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

  Baseline phase week 2

• Interdialytic weight gain

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

  Baseline phase week 3

• Interdialytic weight gain

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

  Baseline phase week 4

• Interdialytic weight gain

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

  Baseline phase week 5

• Interdialytic weight gain

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

  Baseline phase week 6

• Interdialytic weight gain

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

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

• Interdialytic weight gain

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

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

• Interdialytic weight gain

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

  Baseline phase week 9 (those randomised to 10 week baselines)

• Interdialytic weight gain

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

  Baseline phase week 10 (those randomised to 10 week baseline)

• Interdialytic weight gain

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

  intervention week 1

• Interdialytic weight gain

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

  intervention week 2

• Interdialytic weight gain

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

  intervention week 3

• Interdialytic weight gain

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

  intervention week 4

• Interdialytic weight gain

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

  four week follow-up

Secondary Outcomes (10)

• Valuing Questionnaire

  baseline week 1

• Valuing Questionnaire

  baseline week 2

• Valuing Questionnaire

  baseline week 3

• Valuing Questionnaire

  baseline week 4

• Valuing Questionnaire

  baseline week 5

Other Outcomes (19)

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

  Study intake assessment

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

  Baseline week 1

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

  intervention week 1

Study Arms (1)

ACT Matrix

EXPERIMENTAL

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

Behavioral: ACT Matrix

Interventions

ACT Matrix BEHAVIORAL

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

ACT Matrix

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead
• Oxford University Hospitals NHS Trust: collaborator
• Oxford Health NHS Foundation Trust: collaborator

Study Sites (1)

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

Oxford, Oxfordshire, United Kingdom

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Catherine H Crane, DPhil

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single group study - multiple baseline case series

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: March 3, 2022
• Study Start: March 15, 2022
• Primary Completion: October 15, 2022
• Study Completion: October 15, 2022
• Last Updated: December 8, 2022

Record last verified: 2022-01

Locations

GB (1)