Recruiting

CAPABLE Transplant

Sponsor:

Johns Hopkins University

Code:

NCT06326905

Conditions

Quality of Life

Depression

End Stage Renal Disease

Disability Physical

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

CAPABLE Transplant- Open Label Pilot

CAPABLE Transplant- Randomized Control Trial

Study Details

Brief 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.

Conditions

Quality of Life

Depression

End Stage Renal Disease

Disability Physical

Study ID

NCT06326905

Start date

Jan 25, 2025

Status verified date

Jul, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

43 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Open Label Pilot

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

experimental: 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.

active comparator: 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.

Interventions

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 by receiving feedback from the open label pilot participants and CAPABLE clinicians who implemented the pilot to gain their perspective of the acceptability and feasibility of implementing the CAPABLE-Transplant intervention. Based on this feedback, the study team will have developed an adapted iteration of the prototype.

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 measure

  • Waitlist-status as assessed by data obtained by the National Kidney Registry [ Time Frame: 0, 16 weeks, 32 weeks ]

Central Contacts and Locations

Central contacts

Melissa Hladek, PhD

4106142418mhladek1@jh.edu

Meagan Clemence, MS

410-705-5808mcleme26@jh.edu

Locations

Johns Hopkins School of Nursing

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Meagan Clemence, MS

410-705-5808mcleme26@jh.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Jul 20, 2026

Last verified

Jul, 2026

Keywords

  • Activities of Daily Living
  • Instrumental Activities of Daily Living
  • Physical Function
  • Executive Function
  • Home
  • Intervention
  • Kidney Transplant
  • End Stage Renal Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-07-20.