CAPABLE Transplant

Depression Clinical Trial

Official title:

Addressing Inactive Kidney Transplant Waitlist Status Through Adapting a Tailored Psycho-Social-Environmental Program

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06326905
• Other study ID #: IRB00437750
• Secondary ID: K23DK133677-01A1
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: July 1, 2026

Study information

• Verified date: May 2024
• Source: Johns Hopkins University
• Contact: Samantha Curriero, MPH
• Phone: 4436991220
• Email: scurrie6[@]jh.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 33
• Est. completion date: July 1, 2026
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Disability Physical
• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Quality of Life

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins School of Nursing	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	16 weeks
Other	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.	16 weeks
Other	Fidelity as assessed by percent completion of intervention items	% tasks/ patient- directed content delivery per session for Nurse & Occupational Therapist, % completion of home modifications	16 weeks
Primary	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	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.	Baseline, 16 weeks, 32 weeks
Secondary	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.	Baseline, 16 weeks, 32 weeks
Secondary	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.	Baseline, 16 weeks, 32 weeks
Secondary	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.	Baseline, 16 weeks, 32 weeks
Secondary	Change in Social engagement as assessed by the Lubben Social Network Scale	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.	Baseline, 16 weeks, 32 weeks
Secondary	Change in Social engagement as assessed by the Krause-Borawski-Clark Support Interactions Scale	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.	Baseline, 16 weeks, 32 weeks
Secondary	Change in Fatigue/Quality of Life as assessed by the Kidney disease Quality of Life Scale	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.	Baseline, 16 weeks, 32 weeks
Secondary	Change in Frailty as assessed by the Fried Frailty Phenotype	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.	Baseline, 16 weeks, 32 weeks
Secondary	Change in Health Team Communication as assessed by the CollaboRATE Scale Measure	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.	Baseline, 16 weeks, 32 weeks
Secondary	Change in Function as assessed by Lawton & Brody's assessment of Instrumental Activities of Daily Living Scale	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.	Baseline, 16 weeks, 32 weeks
Secondary	Change in Function as assessed by the Katz Index of Independence in Activities of Daily Living	6 questions, each 1 point for a total score of 6. A score closer to 6 indicates high patient independence.	Baseline, 16 weeks, 32 weeks