Exploring the Effects of a Brief Values-Based Intervention on Adherence to Fluid Restriction Recommendations and Quality of Life in Haemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Interdialytic weight gain
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Currently receiving haemodialysis for end-stage kidney disease
- •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.
排除标准
- •• 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
研究组 & 干预措施
ACT Matrix
Participants will each receive the ACT Matrix intervention. Participants will be randomised to multiple start dates, producing different baseline durations.
干预措施: ACT Matrix (Behavioral)
结局指标
主要结局
Interdialytic weight gain
时间窗: four week follow-up
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Dialysis Diet and Fluid Intake Non-Adherence Questionnaire (Vlamink et al., 2001)
时间窗: 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).
Dialysis Diet and Fluid Intake Non-Adherence Questionnaire (Vlamink et al., 2001)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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).
Interdialytic weight gain
时间窗: Baseline phase week 1
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Interdialytic weight gain
时间窗: Baseline phase week 2
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Interdialytic weight gain
时间窗: Baseline phase week 3
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Interdialytic weight gain
时间窗: Baseline phase week 4
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Interdialytic weight gain
时间窗: Baseline phase week 5
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Interdialytic weight gain
时间窗: Baseline phase week 6
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Interdialytic weight gain
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: intervention week 1
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Interdialytic weight gain
时间窗: intervention week 2
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Interdialytic weight gain
时间窗: intervention week 3
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
Interdialytic weight gain
时间窗: intervention week 4
participant's interdialytic weight gain between each dialysis session will be obtained from medical records if possible.
次要结局
- Valuing Questionnaire(baseline week 10 (those randomised to 10 week baselines only))
- 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)
- Valuing Questionnaire(baseline week 6)
- Valuing Questionnaire(baseline week 7 (those randomised to 8 and 10 week baselines only))
- Valuing Questionnaire(baseline week 8 (those randomised to 8 and 10 week baselines only))
- Valuing Questionnaire(baseline week 9 (those randomised to 10 week baselines only))