CAPABLE Transplant
- Conditions
- DepressionQuality of LifeEnd Stage Renal DiseaseDisability Physical
- Interventions
- Behavioral: CAPABLE Transplant- Randomized Control TrialBehavioral: CAPABLE Transplant- Open Label Pilot
- Registration Number
- NCT06326905
- Lead Sponsor
- Johns Hopkins University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 43
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Randomized Control Pilot- Waitlist Control Arm CAPABLE Transplant- Randomized Control Trial 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. Randomized Control Pilot- Intervention Arm CAPABLE Transplant- Randomized Control Trial 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. Open Label Pilot CAPABLE Transplant- Open Label Pilot The Open Label Pilot will include testing the CAPABLE Transplant intervention with 3 individuals on the waitlist.
- Primary Outcome Measures
Name Time Method Waitlist-status as assessed by data obtained by the National Kidney Registry 0, 16 weeks, 32 weeks Death (any cause), Time Inactive
Change of waitlist status (inactive to active, delisting)
- Secondary Outcome Measures
Name Time Method Change in Social engagement as assessed by the Krause-Borawski-Clark Support Interactions Scale Baseline, 16 weeks, 32 weeks The Krause-Borawski-Clark Support Interactions Scale is a 10-item self-reported questionnaire that measures social interactions. The scale is broken down into different domains; scores range from very often (4); fairly often (3); once in a while (2); never (1) or binary-- satisfied (1) or not satisfied (0) depending on domain within the questionnaire. Items are summed to form a single composite score range 10-40, Higher scores on the scale is associated with better personal perception and social support.
Change in self-efficacy as assessed by the Self-Efficacy of Chronic Disease Management Instrument Baseline, 16 weeks, 32 weeks 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.
Change in Fatigue/Quality of Life as assessed by the Kidney disease Quality of Life Scale Baseline, 16 weeks, 32 weeks The Kidney disease Quality of Life Short Form is a 20-item self-report outcome measure for patients on dialysis. Higher scores indicate better health-related quality of life. Scores range from 0-100.
Change in self-efficacy as assessed by the Coping Self-Efficacy Instrument Baseline, 16 weeks, 32 weeks 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.
Change in Depression as assessed by the Patient Health Questionnaire Depression Scale (PHQ-8) Baseline, 16 weeks, 32 weeks 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.
Change in Health Team Communication as assessed by the CollaboRATE Scale Measure Baseline, 16 weeks, 32 weeks The CollaboRATE scale measure is a 3 item self-report questionnaire on patient's shared decision making. It is scored on a 10-point anchored scale, ranging from 0 ("no effort was made") to 9 ("every effort was made"). Higher scores indicate more shared decision making.
Change in Pain as assessed by the Brief Pain Inventory Baseline, 16 weeks, 32 weeks 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.
Change in Social engagement as assessed by the Lubben Social Network Scale Baseline, 16 weeks, 32 weeks The Lubben Social Network Scale is a 7-item questionnaire that measures the size of social networks of family and friends. The score ranges between 0 and 30, with higher scores indicated more social engagement.
Change in Function as assessed by Lawton & Brody's assessment of Instrumental Activities of Daily Living Scale Baseline, 16 weeks, 32 weeks The assessment contains 8 questions with answers that are either a score of 0 or 1. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women, and 0 through 5 for men to avoid potential gender bias.
Change in Function as assessed by the Katz Index of Independence in Activities of Daily Living Baseline, 16 weeks, 32 weeks 6 questions, each 1 point for a total score of 6. A score closer to 6 indicates high patient independence.
Change in Frailty as assessed by the Fried Frailty Phenotype Baseline, 16 weeks, 32 weeks The Fried Frailty Phenotype contains 5 criteria: unintentional weight loss \>10lbs \>5% of body mass in the last year, weakness (handgrip strength measurement), exhaustion (based on the Center for Epidemiological Studies Depression Scale), slow gait (walking time over a distance), and low physical activity. People who had none of the criteria were considered non-frail, people who had 1 and 2 criteria were considered pre-frail, and people who had ≥3 criteria were considered frail.
Trial Locations
- Locations (1)
Johns Hopkins School of Nursing
🇺🇸Baltimore, Maryland, United States