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NCT06326905NARecruiting

CAPABLE Transplant

Johns Hopkins University

Start Date

1/25/2025

Completion Date

12/31/2027

Summary

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.

Eligibility Criteria

Age Range: 18 years to 99 years

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

Interventions

BEHAVIORAL

CAPABLE Transplant- Open Label Pilot

BEHAVIORAL

CAPABLE Transplant- Randomized Control Trial

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Conditions

Quality of LifeDepressionEnd Stage Renal DiseaseDisability Physical

Locations

Johns Hopkins School of Nursing

Baltimore, Maryland 21205

United States