Addressing Inactive Kidney Transplant Waitlist Status Through Adapting a Tailored Psycho-Social-Environmental Program
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Waitlist-status as assessed by data obtained by the National Kidney Registry
研究概览
简要总结
The purpose of this mixed methods study is to adapt CAPABLE as CAPABLE Transplant to accomplish two things: 1) To resolve barriers to being classified as active on the Kidney Transplant (KT) waitlist, 2) as a surgical prehabilitation intervention targeting the pre-frail/ frail KT waitlist population. It consists of two phases- an open label pilot and a randomized waitlist control trial, and 3) pilot test the feasibility and acceptability for CAPABLE Transplant in symptom and waitlist specific metrics amongst low-income active kidney transplant waitlist candidates.
详细描述
CAPABLE is a multicomponent goal-directed program that reduces physical disability by working with the person and environment but has not been explored in prehabilitation research. The purpose of this study is to adapt CAPABLE, an existing evidence-based program for functionally and socio-economically vulnerable older adults, as a prehabilitation intervention for people with frailty awaiting KT.
As in CAPABLE, the delivery characteristics of CAPABLE Kidney Transplant consist of an assessment-driven, individually tailored package of interventions delivered over the course of 4 months by an occupational therapist (OT) (~6 home visits for ≤ 1hour), a registered nurse (RN) (~4 home visits for ≤ 1hour) and a handy worker (HW).
In earlier phases, research team members conducted preliminary activities to design the CAPABLE Kidney Transplant intervention using Human-Centered Design techniques.
This study will seek to accomplish two aims:
- To iteratively refine the CAPABLE -Transplant prototype for those currently KT inactive or those who are active and low-income on the waitlist.
- To pilot test the CAPABLE-Transplant intervention
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The assessment collector will be blinded as to whether a participant is in the intervention or waitlist group
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Deceased Donor Waitlist
- •≥18 years old
- •Community dwelling
- •Current Inactive status or active and had been inactive in the last 18 months for cardiovascular disease, frailty, obesity, social support, mental health, incomplete testing OR Active on the waitlist and low-income
排除标准
- •Living Donor Waitlist
- •Severe cognitive impairment
- •Inactivity expected to last > 3 months (eg cancer treatment)
- •>4 hospitalizations in the last 12 months
- •Current home nursing, physical or occupational therapy
研究组 & 干预措施
Randomized Control Pilot- Intervention Arm
After the open label pilot, 20 participants will be randomized to the CAPABLE Transplant intervention. They will be assessed at baseline, after the 4 month intervention, and after the waitlist control arm.
干预措施: CAPABLE Transplant- Randomized Control Trial (Behavioral)
Open Label Pilot
The Open Label Pilot will include testing the CAPABLE Transplant intervention with 3 individuals on the waitlist.
干预措施: CAPABLE Transplant- Open Label Pilot (Behavioral)
Randomized Control Pilot- Waitlist Control Arm
The waitlist control group, 20 participants, will receive the intervention after they have served as controls to the immediate treatment group, ensuring all participants have access to the intervention.
干预措施: CAPABLE Transplant- Randomized Control Trial (Behavioral)
结局指标
主要结局
Waitlist-status as assessed by data obtained by the National Kidney Registry
时间窗: 0, 16 weeks, 32 weeks
Death (any cause), Time Inactive Change of waitlist status (inactive to active, delisting)
次要结局
- Change in Social engagement as assessed by the Krause-Borawski-Clark Support Interactions Scale(Baseline, 16 weeks, 32 weeks)
- Change in self-efficacy as assessed by the Self-Efficacy of Chronic Disease Management Instrument(Baseline, 16 weeks, 32 weeks)
- Change in Fatigue/Quality of Life as assessed by the Kidney disease Quality of Life Scale(Baseline, 16 weeks, 32 weeks)
- Change in self-efficacy as assessed by the Coping Self-Efficacy Instrument(Baseline, 16 weeks, 32 weeks)
- Change in Depression as assessed by the Patient Health Questionnaire Depression Scale (PHQ-8)(Baseline, 16 weeks, 32 weeks)
- Change in Health Team Communication as assessed by the CollaboRATE Scale Measure(Baseline, 16 weeks, 32 weeks)
- Change in Function as assessed by Lawton & Brody's assessment of Instrumental Activities of Daily Living Scale(Baseline, 16 weeks, 32 weeks)
- Change in Pain as assessed by the Brief Pain Inventory(Baseline, 16 weeks, 32 weeks)
- Change in Social engagement as assessed by the Lubben Social Network Scale(Baseline, 16 weeks, 32 weeks)
- Change in Function as assessed by the Katz Index of Independence in Activities of Daily Living(Baseline, 16 weeks, 32 weeks)
- Change in Frailty as assessed by the Fried Frailty Phenotype(Baseline, 16 weeks, 32 weeks)