Fatigue Self-Management in Primary Care
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ClinicalTrials.gov Identifier: NCT00997451 |
Recruitment Status :
Completed
First Posted : October 19, 2009
Last Update Posted : October 1, 2012
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Sponsor:
Stony Brook University
Information provided by (Responsible Party):
Stony Brook University
Tracking Information | ||||
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First Submitted Date ICMJE | March 28, 2009 | |||
First Posted Date ICMJE | October 19, 2009 | |||
Last Update Posted Date | October 1, 2012 | |||
Study Start Date ICMJE | February 2009 | |||
Actual 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 | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | 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 ICMJE | Not Applicable | |||
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 ICMJE |
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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 | |||
Actual Enrollment ICMJE |
107 | |||
Original Estimated Enrollment ICMJE |
108 | |||
Actual Study Completion Date ICMJE | December 2011 | |||
Actual 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 ICMJE |
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Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | 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 ICMJE | 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 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |