CAPABLE Transplant

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT06326905
Status
Recruiting
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Conditions

  • Depression
  • Disability Physical
  • End Stage Renal Disease
  • Quality of Life

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • CAPABLE Transplant- Open Label Pilot — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Jan 25, 2025
Status verified
Jun 2026
Primary completion
Jul 1, 2026
Completion
Jul 1, 2026

Study Design

Enrollment
43 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins School of NursingBaltimoreMaryland21205
Samantha Curriero, MPH
443-699-1220

Find similar trials in Baltimore, MD

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Johns Hopkins School of Nursing· Baltimore, MD

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