Multicomponent Program for the Integrated Management of Chronic Pain and Depression in Primary Care (DROP)
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ClinicalTrials.gov Identifier: NCT02605278 |
Recruitment Status : Unknown
Verified September 2015 by Jordi Gol i Gurina Foundation.
Recruitment status was: Recruiting
First Posted : November 16, 2015
Last Update Posted : November 16, 2015
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Tracking Information | ||||
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First Submitted Date ICMJE | September 28, 2015 | |||
First Posted Date ICMJE | November 16, 2015 | |||
Last Update Posted Date | November 16, 2015 | |||
Study Start Date ICMJE | January 2015 | |||
Estimated Primary Completion Date | July 2017 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | No Changes Posted | |||
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 | Multicomponent Program for the Integrated Management of Chronic Pain and Depression in Primary Care | |||
Official Title ICMJE | Assessment of a Multicomponent Program for the Integrated Management of Chronic Pain and Depression in Primary Care. Cluster Randomized Clinical Trial | |||
Brief Summary | This study evaluates whether the implementation of an integrated clinical program for chronic musculoskeletal pain and depression behave better clinical outcomes than the usual approach in primary care | |||
Detailed Description | Chronic musculoskeletal pain and depression are extremely common and relevant pathological conditions, and frequently presented as comorbid processes multiplying the impact on health, worsening the prognosis and complicating the care. The integrated management of both disorders is an opportunity to achieve better clinical outcomes. AIM: To determinate whether the implementation of an integrated clinical program for chronic musculoskeletal pain and depression behave better clinical outcomes than the usual approach in primary care METHODS Design: Cluster randomized clinical trials with two arms:
Settings: Primary Care Centers in Tarragona, Spain. Patients: Adults with moderate/severe musculoskeletal pain (Brief Pain Inventory/pain intensity scale > 4 points), with more than three months of evolution and current diagnostic criteria for major depression episode (DSM-IV). Sample: A total sample of 330 patients (165 control arm and 165 intervention arm) divided into 42 clusters of 8 patients. Cluster composition: patients registered with the same doctor. Intervention: Structured program with integrated management for depression/ pain with three main components:
Measurements: "Blind" interviews at 0, 3, 6 and 12 months. Main outcomes:
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
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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 | Unknown status | |||
Estimated Enrollment ICMJE |
330 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Estimated Study Completion Date ICMJE | December 2017 | |||
Estimated Primary Completion Date | July 2017 (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 80 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 | Spain | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02605278 | |||
Other Study ID Numbers ICMJE | PI14/00573 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Jordi Gol i Gurina Foundation | |||
Study Sponsor ICMJE | Jordi Gol i Gurina Foundation | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Jordi Gol i Gurina Foundation | |||
Verification Date | September 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |