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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remotely Delivered Cognitive Behavioral Therapy (CBT) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Cukor, PhD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
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.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
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.
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| 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 |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |