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Fatigue Self-Management in Primary Care
This study has been completed.
Sponsor:
Stony Brook University
Information provided by (Responsible Party):
Stony Brook University
ClinicalTrials.gov Identifier:
NCT00997451
First received: March 28, 2009
Last updated: September 28, 2012
Last verified: September 2012
| Tracking Information | ||||
|---|---|---|---|---|
| First Received Date ICMJE | March 28, 2009 | |||
| Last Updated Date | September 28, 2012 | |||
| Start Date ICMJE | February 2009 | |||
| Primary Completion Date | December 2011 (Final data collection date for primary outcome measure) | |||
| Current Primary Outcome Measures ICMJE |
Fatigue Severity Scale [ Time Frame: 3 months, 6 months, 15 months ] | |||
| Original Primary Outcome Measures ICMJE | Same as current | |||
| Change History | Complete list of historical versions of study NCT00997451 on ClinicalTrials.gov Archive Site | |||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | |||
| Current Other Outcome Measures ICMJE | Not Provided | |||
| Original Other Outcome Measures ICMJE | Not Provided | |||
| Descriptive Information | ||||
| Brief Title ICMJE | Fatigue Self-Management in Primary Care | |||
| Official Title ICMJE | Fatigue Self- Management in Primary Care: Efficacy, Credibility, and Economics | |||
| Brief Summary | This study will evaluate, in a primary care setting, the effectiveness of a brief self-management behavioral treatment in patients with medically unexplained chronic fatigue. The hypothesis will be tested that fatigue self-management will yield improvements in fatigue,functioning, and distress in comparison to the two control conditions: standard medical care alone or standard medical care plus an attention control symptom monitoring condition. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase | Not Provided | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Investigator) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Enrollment ICMJE | 107 | |||
| Completion Date | December 2011 | |||
| Primary Completion Date | December 2011 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 70 Years (Adult, Senior) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00997451 | |||
| Other Study ID Numbers ICMJE | NIH 5R01NR010229 - 03 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Stony Brook University | |||
| Study Sponsor ICMJE | Stony Brook University | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
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| PRS Account | Stony Brook University | |||
| Verification Date | September 2012 | |||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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