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Behavioral Intervention

CAPABLE Program for Kidney Failure

N/A

Waitlist Available

Led By Melissa Hladek, PhD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0, 16 weeks, 32 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to modify a program called CAPABLE for kidney transplant patients to help them overcome barriers to getting on the transplant waitlist and to improve the health of frail patients awaiting a kidney transplant. The

Who is the study for?

This trial is for people over 50 on the deceased donor waitlist for a kidney transplant, living at home, who are currently inactive or were recently due to health or social issues. It's not for those with severe cognitive problems, expected long-term inactivity, frequent hospitalizations, or current home therapy.

What is being tested?

CAPABLE Transplant aims to help patients overcome barriers to being active on the kidney transplant list and prepare them physically and mentally for surgery. The study has two parts: an initial pilot test where everyone gets the intervention and a second part where participants are randomly chosen to receive it.

What are the potential side effects?

Since CAPABLE Transplant is more of a supportive program rather than a drug treatment, side effects may be minimal but could include discomfort from increased activity or emotional distress during counseling sessions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0, 16 weeks, 32 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0, 16 weeks, 32 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 16 weeks, 32 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

Change in Fatigue/Quality of Life as assessed by the Kidney disease Quality of Life Scale

Change in Frailty as assessed by the Fried Frailty Phenotype

+8 more

Other study objectives

Acceptability at endpoint of intervention assessed by survey

Feasibility as assessed by qualitative questions

Fidelity as assessed by percent completion of intervention items

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Randomized Control Pilot- Intervention ArmExperimental Treatment1 Intervention

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.

Group II: Open Label PilotExperimental Treatment1 Intervention

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

Group III: Randomized Control Pilot- Waitlist Control ArmActive Control1 Intervention

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.

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