Clinical trial NCT06326905: CAPABLE Transplant
Official title: Addressing Inactive Kidney Transplant Waitlist Status Through Adapting a Tailored Psycho-Social-Environmental Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-03-22
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Waitlist Control Trial
Primary purpose: PREVENTION

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.

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 or those who are active and low-income on the waitlist.
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.

Eligibility criteria: Inclusion Criteria:

* 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 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

Primary outcomes:
measure: Waitlist-status as assessed by data obtained by the National Kidney Registry
timeFrame: 0, 16 weeks, 32 weeks
Secondary outcomes:
measure: Change in self-efficacy as assessed by the Coping Self-Efficacy Instrument
timeFrame: Baseline, 16 weeks, 32 weeks
measure: Change in self-efficacy as assessed by the Self-Efficacy of Chronic Disease Management Instrument
timeFrame: Baseline, 16 weeks, 32 weeks
measure: Change in Pain as assessed by the Brief Pain Inventory
timeFrame: Baseline, 16 weeks, 32 weeks
measure: Change in Depression as assessed by the Patient Health Questionnaire Depression Scale (PHQ-8)
timeFrame: Baseline, 16 weeks, 32 weeks
measure: Change in Social engagement as assessed by the Lubben Social Network Scale
timeFrame: Baseline, 16 weeks, 32 weeks
measure: Change in Social engagement as assessed by the Krause-Borawski-Clark Support Interactions Scale
timeFrame: Baseline, 16 weeks, 32 weeks
measure: Change in Fatigue/Quality of Life as assessed by the Kidney disease Quality of Life Scale
timeFrame: Baseline, 16 weeks, 32 weeks
measure: Change in Frailty as assessed by the Fried Frailty Phenotype
timeFrame: Baseline, 16 weeks, 32 weeks
measure: Change in Health Team Communication as assessed by the CollaboRATE Scale Measure
timeFrame: Baseline, 16 weeks, 32 weeks
measure: Change in Function as assessed by Lawton & Brody's assessment of Instrumental Activities of Daily Living Scale
timeFrame: Baseline, 16 weeks, 32 weeks
measure: Change in Function as assessed by the Katz Index of Independence in Activities of Daily Living
timeFrame: Baseline, 16 weeks, 32 weeks
Other outcomes:
measure: Acceptability at endpoint of intervention assessed by survey
timeFrame: 16 weeks
measure: Feasibility as assessed by qualitative questions
timeFrame: 16 weeks
measure: Fidelity as assessed by percent completion of intervention items
timeFrame: 16 weeks
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Nursing
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Nursing
name: Melissa Hladek, PhD
role: PRINCIPAL_INVESTIGATOR
References: