CAPABLE Transplant

ConditionsQuality of Life Depression End Stage Renal Disease Disability Physical

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-99

SponsorJohns Hopkins University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Living Donor Waitlist

Severe cognitive impairment

Inactivity expected to last > 3 months (eg cancer treatment)

>4 hospitalizations in the last 12 months

Trial design

Design model

Parallel

Treatments tested in this trial

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.
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.

Treatment groups

43 Participants

are divided into 3 treatment groups

Group A: Open Label PilotExperimental treatment 1 intervention

Group B: Randomized Control Pilot- Intervention ArmExperimental treatment 1 intervention

Group C: Randomized Control Pilot- Waitlist Control ArmActive comparator 1 intervention

Trial outcomes

Primary outcomes

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)

Time frame

0, 16 weeks, 32 weeks

Secondary outcomes

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

Coping Self-Efficacy is a 13 item instrument on a scale of 0 ('can't do at all') to 10 ('certain can do'). A higher score indicates higher level of self-efficacy when implementing coping strategies. Score range 0-130.

Time frame

Baseline, 16 weeks, 32 weeks

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

Self-Efficacy of Chronic Disease Management Instrument is a 6 item instrument on a visual analog scale, ranging from 1 (not at all confident) to 10 (totally confident). Lower scores indicate lower self-efficacy as indicated by confidence. Score range 6-60.

Time frame

Baseline, 16 weeks, 32 weeks

Change in Pain as assessed by the Brief Pain Inventory

The Brief Pain Inventory - is a 4-item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. The patient is asked to rate their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10 point scale. For the 10 point scale, 0 indicated no pain and 10 indicates the worst imaginable pain. Score range 0-40.

Time frame

Baseline, 16 weeks, 32 weeks

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

The PHQ-8 contains 8 questions, with a 0-3 scale. A score of 10 or greater is considered major depression, 20 or more is severe major depression. Score range 0-30.

Time frame

Baseline, 16 weeks, 32 weeks

Other outcomes

Acceptability at endpoint of intervention assessed by survey

Score on Likert scale-based questions re: program content \& structure satisfaction, willingness to recommend. Survey developed by study team.

Time frame

16 weeks

Feasibility as assessed by qualitative questions

Open/ Close Ended Questions, Recruitment Rate, Completion Rate, Data Collection Rate, Mean time for survey administration, Withdrawal Rate, Cost. Questions developed by study team.

Time frame

16 weeks

Fidelity as assessed by percent completion of intervention items

% tasks/ patient- directed content delivery per session for Nurse \& Occupational Therapist, % completion of home modifications

Time frame

16 weeks