A Pilot Trial of Strategies to Reduce Fatigue for People With Chronic Kidney Disease (CKD)

NYU Langone Health1 site in 1 country5 target enrollmentJanuary 30, 2025

ConditionsChronic Kidney Diseases Fatigue

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Chronic Kidney Diseases
Sponsor: NYU Langone Health
Enrollment: 5
Locations: 1
Primary Endpoint: Session Adherence
Status: Completed
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

In this pilot trial, investigators will pilot test a cognitive behavioral intervention for acceptability and proof of concept for a larger future trial to be submitted for federal funding. This is a one-group design with qualitative and quantitative data collection integrated into the intervention.

Registry

clinicaltrials.gov

Start Date

January 30, 2025

End Date

September 16, 2025

Last Updated

4 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

NYU Langone Health

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Interest in participating in a fatigue study
•Age ≥18 years old
•Estimated glomerular filtration rate (eGFR) 15-44 mL/min/1.73 m2
•Ability and willingness to provide informed consent
•Ability to speak English
•Ability to walk
•Ability to join remote study sessions via WebEx

Exclusion Criteria

•Current involvement in an activity/exercise program
•High likelihood of a kidney transplant within 6 months (assessed via the medical record)
•Any safety concerns about increased walking (assessed via the medical record)

Outcomes

Primary Outcomes

Session Adherence

Time Frame: Up to Week 12

Measure of feasibility; calculated as the percentage of planned sessions that were actually attended by participants.

Secondary Outcomes

Change in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score(Baseline, Week 12)
Change in Dialysis Symptom Index (DSI) Score(Baseline, Week 12)