RecruitingNot ApplicableNCT06326905

CAPABLE Transplant

Addressing Inactive Kidney Transplant Waitlist Status Through Adapting a Tailored Psycho-Social-Environmental Program


Sponsor

Johns Hopkins University

Enrollment

43 participants

Start Date

Jan 25, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria4

  • 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 Criteria5

  • 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

BEHAVIORALCAPABLE 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.

BEHAVIORALCAPABLE 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.


Locations(1)

Johns Hopkins School of Nursing

Baltimore, Maryland, United States

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NCT06326905


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