CAPABLE Transplant

Johns Hopkins University

Status: Enrolling

Conditions: Quality of Life; End Stage Renal Disease; Depression; Disability Physical

Treatments: Behavioral: CAPABLE Transplant- Randomized Control Trial; Behavioral: CAPABLE Transplant- Open Label Pilot

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06326905

K23DK133677-01A1 (U.S. NIH Grant/Contract)

IRB00437750

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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43 participants in 3 patient groups

Open Label Pilot

Experimental group

Description:

The Open Label Pilot will include testing the CAPABLE Transplant intervention with 3 individuals on the waitlist.

Treatment:

Behavioral: CAPABLE Transplant- Open Label Pilot

Randomized Control Pilot- Intervention Arm

Experimental group

Description:

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.

Treatment:

Behavioral: CAPABLE Transplant- Randomized Control Trial

Randomized Control Pilot- Waitlist Control Arm

Active Comparator group

Description:

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.

Treatment:

Behavioral: CAPABLE Transplant- Randomized Control Trial