Fatigue Reduction in Chronic Kidney Disease (CKD)
A Pilot Trial of Strategies to Reduce Fatigue for People With Chronic Kidney Disease (CKD)
1 other identifier
interventional
5
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 7, 2025
CompletedFirst Posted
Study publicly available on registry
January 10, 2025
CompletedStudy Start
First participant enrolled
January 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 16, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 16, 2025
CompletedDecember 18, 2025
December 1, 2025
8 months
January 7, 2025
December 10, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Session Adherence
Measure of feasibility; calculated as the percentage of planned sessions that were actually attended by participants.
Up to Week 12
Secondary Outcomes (4)
Change in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score
Baseline, Week 6
Change in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score
Baseline, Week 12
Change in Dialysis Symptom Index (DSI) Score
Baseline, Week 6
Change in Dialysis Symptom Index (DSI) Score
Baseline, Week 12
Study Arms (1)
Remotely Delivered Cognitive Behavioral Therapy (CBT)
EXPERIMENTALPatients with non-dialysis dependent kidney disease who have complaints of fatigue will be enrolled. Participants will receive remotely delivered CBT sessions, which will weekly with the goal of having 10 45-minute sessions over 12 weeks.
Interventions
10 sessions of remotely delivered CBT; each session is about 45 minutes in length. The aim of the sessions is to cultivate skills that promote activity and reduce fatigue and its impact on daily activities.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Cukor, PhD
NYU Langone Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2025
First Posted
January 10, 2025
Study Start
January 30, 2025
Primary Completion
September 16, 2025
Study Completion
September 16, 2025
Last Updated
December 18, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Daniel.Cukor@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Daniel.Cukor@nyulangone.org. The protocol will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.