Anxiety & Depression Association of America

CAPABLE Transplant

Purpose

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 and 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.

Conditions

Quality of Life
Depression
End Stage Renal Disease
Disability Physical

Eligibility

Eligible Ages: Over 50 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Deceased Donor Waitlist - ≥50 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.

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

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Waitlist Control Trial
Primary Purpose: Prevention
Masking: Single (Outcomes Assessor)
Masking Description: The assessment collector will be blinded as to whether a participant is in the intervention or waitlist group

Arm Groups

Arm	Description	Assigned Intervention
Experimental Open Label Pilot	The Open Label Pilot will include testing the CAPABLE Transplant intervention with 3 individuals on the waitlist.	Behavioral: 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.
Experimental Randomized Control Pilot- Intervention Arm	After the open label pilot, 15 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.	Behavioral: 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.
Active Comparator Randomized Control Pilot- Waitlist Control Arm	The waitlist control group, 15 participants, will receive the intervention after they have served as controls to the immediate treatment group, ensuring all participants have access to the intervention.	Behavioral: 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.

Recruiting Locations

More Details

Status: Recruiting
Sponsor: Johns Hopkins University

Study Contact

Samantha Curriero, MPH
4436991220
scurrie6@jh.edu

Detailed 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. - 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.