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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Participants will receive a 4 session psychological intervention based on the ACT Matrix
Renal and Transplant Medicine Unit (and satellite units), Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire, United Kingdom
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: Baseline phase week 1
Interdialytic weight gain
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Time frame: Baseline phase week 2
Interdialytic weight gain
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Time frame: Baseline phase week 3
Interdialytic weight gain
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Time frame: Baseline phase week 4
Interdialytic weight gain
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Time frame: Baseline phase week 5
Interdialytic weight gain
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Time frame: Baseline phase week 6
Interdialytic weight gain
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: intervention week 1
Interdialytic weight gain
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Time frame: intervention week 2
Interdialytic weight gain
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Time frame: intervention week 3
Interdialytic weight gain
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Time frame: intervention week 4
Interdialytic weight gain
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Time frame: four week follow-up
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: baseline week 10 (those randomised to 10 week baselines only)