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临床试验/NCT06036225
NCT06036225招募中不适用

PREhabilitation for Patients Awaiting a Liver Transplantation: The Development and Feasibility Testing of a Remote Multicomponent pREhabilitation Intervention: PREPARE

Belfast Health and Social Care Trust1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年7月24日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
Adherence

研究概览

简要总结

This is a study developing a prehabilitation intervention and then testing the acceptability and feasibility of the intervention.

Start date Aug 2022 for Focus groups and Feb 2023 Co-design workshops and feasibility study date pending

详细描述

This study is using focus groups and experience based co-design workshops to co-design a remote multicomponent prehabilitation intervention for patients awaiting liver transplantation.

Once the intervention is developed it will then be tested for acceptability and feasibility with the liver transplantation cohort in Belfast Northern Ireland.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • on the transplant waiting list
  • grade 3 below for encephalopathy

排除标准

  • grade 4 above encephalopathy
  • Known adverse reaction to exercise
  • New stroke
  • lacks capacity to consent

结局指标

主要结局

Adherence

时间窗: 6 months

This will be recorded using percentage and will be defined by 1. Number of participants who attended 1:1 sessions. 2. Number of participants who attended the group exercise classes using a class log. 3. Number of participants who attend the online monthly peer support sessions while active on the liver transplantation waiting list. 4. Number of participants who accessed the website/web app. 5. Which sections of the website/web app are utilised and the number of participants who access each section. 6. Number of participants who wear the activity tracker and report weekly step count. Min score 0% Max Score 100% Higher values indicate a higher adherence rate.

Retention

时间窗: 6 months

This will be recorded using percentage and will be defined by 1. Number of participants who completed the baseline assessment. 2. Number of participants who completed the 12-week iPRehab study. 3. Number of participants who completed the assessment 1 week post the iPRehab study. 4. Number of participants who completed the assessment 12 weeks post the iPRehab study. 5. Number of participants who drop out and the reasons Min score 0% Max Score 100% Higher values indicate a higher retention rate.

Recruitment

时间窗: 6 months

It will be presented in percentage form and will be defined by 1. Number of participants active on the list. 2. Number of participants eligible to participate. 3. Number of participants informed about the iPRehab study. 4. Number of participants who were interested in participating. 5. Number of participants recruited. 6. Number of participants interested but didn't recruit and reasons why. 7. Number of participants who own a computer/phone/tablet. 8. Number of participants who can use a computer/phone/tablet independently. 9. Number of participants who need support to use a device. Detail the support required. Min score 0% Max Score 100% Higher values indicate a higher recruitment rate.

Acceptability

时间窗: 6 months

This will be measured using an acceptability questionnaire. Min score 0% Max Score 100% Higher values indicate a higher acceptability.

次要结局

  • Physical function(6 months)
  • Frailty(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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