Chronic Kidney Diseases, Fatigue
Conditions
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.
Interventions
BEHAVIORALCognitive 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.
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Session Adherence | Up to Week 12 | Measure of feasibility; calculated as the percentage of planned sessions that were actually attended by participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score | 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. |
| Change in Dialysis Symptom Index (DSI) Score | 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. |
Countries
United States
Outcome results
None listed