Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
All Genders
ID06326905

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

Led by Johns Hopkins University · Updated on 2026-06-02

43

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

J

Johns Hopkins University

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating CAPABLE Transplant, an adapted version of an evidence-based program designed to reduce physical disability and improve function in socio-economically vulnerable older adults. This study focuses on people with frailty who are waiting for a kidney transplant and aims to overcome barriers to being classified as active on the kidney transplant waitlist. It includes two phases: an open-label pilot and a randomized waitlist control trial, and also tests the feasibility and acceptance of CAPABLE Transplant among low-income active kidney transplant candidates. The intervention involves a personalized and assessment-driven program delivered over four months by a team consisting of an occupational therapist, a registered nurse, and a handy worker. Participants receive approximately six home visits from the occupational therapist and four home visits from the nurse, each lasting up to one hour, along with support from the handy worker. The open-label pilot tests the initial CAPABLE Transplant intervention and gathers feedback to refine the program. Following this, 40 participants are randomized into either an immediate intervention group or a waitlist control group, with all participants eventually receiving the intervention. Participants will be assessed at baseline, after the four-month intervention, and following the waitlist control period. Researchers will monitor waitlist status through data from the National Kidney Registry and track changes in self-efficacy, pain, depression, social engagement, fatigue, frailty, health team communication, and daily functioning using various validated scales. This comprehensive evaluation will help determine the program's impact on symptom management and waitlist-specific outcomes over the course of the study.

CONDITIONS

Brief Title

CAPABLE Transplant

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • On the deceased donor kidney transplant waitlist
  • 18 to 99 years old
  • Living in the community
  • Currently inactive on the waitlist or active but have been inactive in the last 18 months due to cardiovascular disease, frailty, obesity, social support, mental health, or incomplete testing
  • Active on the waitlist and low-income
Not Eligible

You will not qualify if you...

  • On the living donor kidney transplant waitlist
  • Severe cognitive impairment
  • Inactivity expected to last more than 3 months (e.g., cancer treatment)
  • More than 4 hospitalizations in the past 12 months
  • Currently receiving home nursing, physical therapy, or occupational therapy

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Outpatient Treatment

Duration - 4 months

Participants receive a tailored CAPABLE Transplant intervention consisting of home visits by an occupational therapist, registered nurse, and a handy worker over 4 months to improve physical function and address psychosocial and environmental needs.

Approximately 10 home visits (6 occupational therapist, 4 registered nurse)

Follow-up

Duration - Up to 4 months following treatment

Participants are assessed after the intervention period and again after the waitlist control arm to monitor changes in health status and waitlist status.

2 follow-up visits (in-person)

Trial Site Locations

Total: 1 location

1

Johns Hopkins School of Nursing

Baltimore, Maryland, United States, 21205

Actively Recruiting

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Research Team

M

Melissa Hladek, PhD

K

Katie Mark, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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