End Stage Renal DiseaseNCT05264220
Fluid Restriction and Quality of Life on Dialysis
A study testing ACT Matrix in people with End Stage Renal Disease, run by University of Oxford at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- ACT Matrix
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Mar 2022to 15 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Renal and Transplant Medicine Unit (and satellite units), Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire
About this study
Official title: Exploring the Effects of a Brief Values-Based Intervention on Adherence to Fluid Restriction Recommendations and Quality of Life in Haemodialysis Patients
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.
Read the 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.
- Conditions
- End Stage Renal Disease
- Being tested
- ACT Matrix
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT MatrixBehavioural
Participants will receive a 4 session psychological intervention based on the ACT Matrix
| Study group | Role | What they receive |
|---|---|---|
| ACT Matrix | Experimental | Participants will each receive the ACT Matrix intervention. Participants will be randomised to multiple start dates, producing different baseline durations. Receives: Behavioral: ACT Matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Baseline phase week 1
Interdialytic weight gain
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Measured: Baseline phase week 2
Interdialytic weight gain
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Measured: Baseline phase week 3
Interdialytic weight gain
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Measured: Baseline phase week 4
Interdialytic weight gain
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Measured: Baseline phase week 5
Interdialytic weight gain
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Measured: Baseline phase week 6
Interdialytic weight gain
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: intervention week 1
Interdialytic weight gain
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Measured: intervention week 2
Interdialytic weight gain
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Measured: intervention week 3
Interdialytic weight gain
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Measured: intervention week 4
Interdialytic weight gain
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Measured: four week follow-up
Secondary outcomes (10)
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).
Measured: baseline week 1
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).
Measured: baseline week 2
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).
Measured: baseline week 3
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).
Measured: baseline week 4
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).
Measured: baseline week 5
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).
Measured: baseline week 6
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).
Measured: baseline week 7 (those randomised to 8 and 10 week baselines only)
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).
Measured: baseline week 8 (those randomised to 8 and 10 week baselines only)
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).
Measured: baseline week 9 (those randomised to 10 week baselines only)
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).
Measured: baseline week 10 (those randomised to 10 week baselines only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start15 Mar 2022
- Primary completion15 Oct 2022
- Study completion15 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group study - multiple baseline case series
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust, Oxford Health NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Catherine H Crane, DPhil, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05264220
- Sponsor's protocol ID
- PID15290
- Status last verified
- Jan 2022
- First submitted
- 13 Jan 2022
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effects of a Brief Values-Based Intervention on Adherence to Fluid Restriction Recommendations and Quality of Life in Haemodialysis Patients
- ClinicalTrials.gov ID
- NCT05264220
- Acronym / sponsor ID
- PID15290
- Conditions
- End Stage Renal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust, Oxford Health NHS Foundation Trust
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 15 Oct 2022 (actual)
- First posted
- 3 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group study - multiple baseline case series
| Arm | Type | Receives |
|---|---|---|
| ACT Matrix | Experimental | Behavioral: ACT MatrixParticipants will each receive the ACT Matrix intervention. Participants will be randomised to multiple start dates, producing different baseline durations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- • Lack of capacity to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT MatrixParticipants will receive a 4 session psychological intervention based on the ACT Matrix | Behavioural | ACT Matrix |
Primary outcome
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).
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).
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).
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).
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).
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).
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
10 secondary outcomes
Valuing Questionnaire
Time frame: baseline week 1
Valuing Questionnaire
Time frame: baseline week 2
Valuing Questionnaire
Time frame: baseline week 3
Valuing Questionnaire
Time frame: baseline week 4
Valuing Questionnaire
Time frame: baseline week 5
Valuing Questionnaire
Time frame: baseline week 6
Valuing Questionnaire
Time frame: baseline week 7 (those randomised to 8 and 10 week baselines only)
Valuing Questionnaire
Time frame: baseline week 8 (those randomised to 8 and 10 week baselines only)
Valuing Questionnaire
Time frame: baseline week 9 (those randomised to 10 week baselines only)
Valuing Questionnaire
Time frame: baseline week 10 (those randomised to 10 week baselines only)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine H Crane, DPhil principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT Matrix in people with End Stage Renal Disease, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dialysis Diet and Fluid Intake Non-Adherence Questionnaire (Vlamink et al., 2001) (time frame: baseline phase week 2). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2022.