Fatigue Reduction in Chronic Kidney Disease (CKD)

Not Applicable

Recruiting

• Conditions: Chronic Kidney Diseases; Fatigue

• Registration Number: NCT06768983
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01-01
• Study First Submitted: 2025-01-07
• Study First Submitted QC: 2025-01-07
• Last Update Submitted: 2025-01-07
• Study First Posted: 2025-01-10
• Last Update Posted: 2025-01-10
• Primary Completion: 2026-01-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Session Adherence	Up to Week 12	Measure of feasibility; calculated as the percentage of planned sessions that were actually attended by participants.

Secondary Outcome Measures

Name	Time	Method
Change in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score	Baseline, Week 12	The FACIT Measurement System is a collection of health-related quality of life (HRQOL) questionnaires targeted to the management of chronic illness. The Fatigue Subscale comprises 13 items and measures symptoms of fatigue. Each item is rated on a scale from 0 (not at all) to 4 (very much); the total score is the sum of responses and ranges from from 0 to 52; lower scores indicate greater fatigue.
Change in Dialysis Symptom Index (DSI) Score	Baseline, Week 12	The DSI is 30-item assessment of CKD-related unpleasant symptoms. Each item is rated on a scale from 0 (not at all) to 4 (very much). The total score is the sum of the responses, ranging from 0 to 120. A higher score indicates a greater symptom burden.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States