CAPABLE Transplant
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CAPABLE Transplant- Open Label Pilot, CAPABLE Transplant- Randomized Control Trial.
- Who it may be relevant to
- Registry conditions: Quality of Life, Depression, End Stage Renal Disease, Disability Physical. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Addressing Inactive Kidney Transplant Waitlist Status Through Adapting a Tailored Psycho-Social-Environmental Program
Overview
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.
Detailed description
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:
1. To iteratively refine the CAPABLE -Transplant prototype for those currently KT inactive or those who are active and low-income on the waitlist. 2. To pilot test the CAPABLE-Transplant intervention
The investigators will collect feedback during the open label pilot to further refine the intervention that will be tested as part of the randomized control trial.
Interventions
- Behavioral CAPABLE Transplant- Open Label Pilot
As in CAPABLE, the delivery characteristics of CAPABLE 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). Adaptations targeting those currently KT inactive will be made on a per-client basis as part of the open-label pilot. We will further refine and develop the intervention b - Behavioral CAPABLE Transplant- Randomized Control Trial
As in CAPABLE, the delivery characteristics of CAPABLE 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). Refinements based on the open label pilot results will be included.
Primary outcome measures
- Waitlist-status as assessed by data obtained by the National Kidney Registry [Time frame: 0, 16 weeks, 32 weeks]
Secondary outcome measures (11)
- Change in self-efficacy as assessed by the Coping Self-Efficacy Instrument [Time frame: Baseline, 16 weeks, 32 weeks]
- Change in self-efficacy as assessed by the Self-Efficacy of Chronic Disease Management Instrument [Time frame: Baseline, 16 weeks, 32 weeks]
- Change in Pain as assessed by the Brief Pain Inventory [Time frame: Baseline, 16 weeks, 32 weeks]
- Change in Depression as assessed by the Patient Health Questionnaire Depression Scale (PHQ-8) [Time frame: Baseline, 16 weeks, 32 weeks]
- Change in Social engagement as assessed by the Lubben Social Network Scale [Time frame: Baseline, 16 weeks, 32 weeks]
- Change in Social engagement as assessed by the Krause-Borawski-Clark Support Interactions Scale [Time frame: Baseline, 16 weeks, 32 weeks]
- Change in Fatigue/Quality of Life as assessed by the Kidney disease Quality of Life Scale [Time frame: Baseline, 16 weeks, 32 weeks]
- Change in Frailty as assessed by the Fried Frailty Phenotype [Time frame: Baseline, 16 weeks, 32 weeks]
- Change in Health Team Communication as assessed by the CollaboRATE Scale Measure [Time frame: Baseline, 16 weeks, 32 weeks]
- Change in Function as assessed by Lawton & Brody's assessment of Instrumental Activities of Daily Living Scale [Time frame: Baseline, 16 weeks, 32 weeks]
- Change in Function as assessed by the Katz Index of Independence in Activities of Daily Living [Time frame: Baseline, 16 weeks, 32 weeks]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Johns Hopkins School of Nursing — Baltimore
Identifiers
NCT: NCT06326905 · IRB00437750 · K23DK133677-01A1