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Behavioral Intervention

Open Label Pilot for Quality of Life

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

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Waitlist-status as assessed by data obtained by the National Kidney Registry
Secondary outcome measures
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 outcome measures
Acceptability at endpoint of intervention assessed by survey
Feasibility as assessed by qualitative questions
Fidelity as assessed by percent completion of intervention items

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.

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,266 Previous Clinical Trials
14,837,464 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,360 Previous Clinical Trials
4,314,819 Total Patients Enrolled
Melissa Hladek, PhDPrincipal InvestigatorJohns Hopkins School of Nursing

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants currently being recruited for this trial?

"Per the data on clinicaltrials.gov, recruitment for this particular study is closed. The trial was initially listed on May 1st, 2024, with the most recent update made on March 18th, 2024. Despite this trial not recruiting anymore participants, there are currently an additional 2161 trials open to enrollment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
CAPABLE Transplant
2024. "CAPABLE Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06326905.
~22 spots leftby Sep 2025
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