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Completed

NCT Number: NCT06768983

Fatigue Reduction in 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.

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Key information

Conditions

Chronic Kidney Diseases Chronic Disease Disease Attributes Fatigue Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cognitive Behavioral Therapy (CBT)

Behavioral

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.

Primary outcomes

  1. 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

  1. Change in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score

    Time frame: Baseline, Week 6

    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.

  2. Change in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score

    Time frame: 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.

  3. Change in Dialysis Symptom Index (DSI) Score

    Time frame: Baseline, Week 6

    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.

  4. Change in Dialysis Symptom Index (DSI) Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 10, 2025
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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