CAPABLE Transplant

NCT06326905 | Recruiting

• 2 other identifiers: IRB00437750K23DK133677-01A1
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Waitlist-status as assessed by data obtained by the National Kidney Registry

  Death (any cause), Time Inactive Change of waitlist status (inactive to active, delisting)

  0, 16 weeks, 32 weeks

Secondary Outcomes (11)

• Change in self-efficacy as assessed by the Coping Self-Efficacy Instrument

  Baseline, 16 weeks, 32 weeks

• Change in self-efficacy as assessed by the Self-Efficacy of Chronic Disease Management Instrument

  Baseline, 16 weeks, 32 weeks

• Change in Pain as assessed by the Brief Pain Inventory

  Baseline, 16 weeks, 32 weeks

• Change in Depression as assessed by the Patient Health Questionnaire Depression Scale (PHQ-8)

  Baseline, 16 weeks, 32 weeks

• Change in Social engagement as assessed by the Lubben Social Network Scale

  Baseline, 16 weeks, 32 weeks

Other Outcomes (3)

• Acceptability at endpoint of intervention assessed by survey

  16 weeks

• Feasibility as assessed by qualitative questions

  16 weeks

• Fidelity as assessed by percent completion of intervention items

  16 weeks

Study Arms (3)

Open Label Pilot

EXPERIMENTAL

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

Behavioral: CAPABLE Transplant- Open Label Pilot

Randomized Control Pilot- Intervention Arm

EXPERIMENTAL

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.

Behavioral: CAPABLE Transplant- Randomized Control Trial

Randomized Control Pilot- Waitlist Control Arm

ACTIVE COMPARATOR

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.

Behavioral: CAPABLE Transplant- Randomized Control Trial

Interventions

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.

Randomized Control Pilot- Intervention Arm; Randomized Control Pilot- Waitlist Control Arm

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.

Open Label Pilot

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Johns Hopkins School of Nursing

Baltimore, Maryland, 21205, United States

RECRUITING

MeSH Terms

Conditions

Depression; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Melissa Hladek, PhD

  Johns Hopkins School of Nursing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa Hladek, PhD

CONTACT

4106142418; mhladek1@jh.edu

Katie Mark, PhD

CONTACT

443-858-6269; kmarx1@jh.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessment collector will be blinded as to whether a participant is in the intervention or waitlist group
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Waitlist Control Trial

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: March 22, 2024
• Study Start: January 25, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)