Fatigue Reduction in Chronic Kidney Disease (CKD)

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

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.

Study Overview

• Status: Completed
• Conditions: Fatigue; Chronic Kidney Diseases
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy (CBT)

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remotely Delivered Cognitive Behavioral Therapy (CBT); Patients 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.	Behavioral: Cognitive Behavioral Therapy (CBT); 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score	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.	Baseline, Week 6
Change in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score	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.	Baseline, Week 12
Change in Dialysis Symptom Index (DSI) Score	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.	Baseline, Week 6
Change in Dialysis Symptom Index (DSI) Score	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.	Baseline, Week 12

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Daniel Cukor, PhD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2025
• Primary Completion (Actual): September 16, 2025
• Study Completion (Actual): September 16, 2025

Study Registration Dates

• First Submitted: January 7, 2025
• First Submitted That Met QC Criteria: January 7, 2025
• First Posted (Actual): January 10, 2025

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Fatigue; Renal Insufficiency, Chronic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy
• Other Study ID Numbers: 24-01055

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No