Collaborative Cardiac Care Project (C3P)
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ClinicalTrials.gov Identifier: NCT00105664 |
Recruitment Status
:
Completed
First Posted
: March 17, 2005
Last Update Posted
: April 7, 2015
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Sponsor:
VA Office of Research and Development
Information provided by (Responsible Party):
VA Office of Research and Development
Tracking Information | ||||
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First Submitted Date ICMJE | March 16, 2005 | |||
First Posted Date ICMJE | March 17, 2005 | |||
Last Update Posted Date | April 7, 2015 | |||
Study Start Date ICMJE | October 2004 | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures ICMJE |
Symptom control, quality of life and satisfaction at one year; improved practitioner compliance with national clinical practice guidelines over the one-year intervention period | |||
Original Primary Outcome Measures ICMJE |
Patient-reported changes in scores on the angina frequency, physical limitation, and quality of life scales of the SAQ | |||
Change History | Complete list of historical versions of study NCT00105664 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Marginal cost effectiveness during one-year study period | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Collaborative Cardiac Care Project | |||
Official Title ICMJE | Collaborative Cardiac Care Project (C3P) | |||
Brief Summary | Data from VA-funded studies and the broader literature indicate that chronic stable angina (CSA) is prevalent, under recognized, under treated and associated with reduced quality of life. There are substantial opportunities for improving care of patients with this debilitating and potentially fatal problem. Because primary care providers manage most patients with CSA, efforts to improve care must necessarily involve the primary care delivery system. C3P is composed of a set of interventions employing a Collaborative Care Team model, which has been shown to be effective in managing other chronic illnesses in the primary care setting. | |||
Detailed Description | Objectives of the proposed project are to: 1) ascertain whether a collaborative approach to managing CSA in primary care results in better symptom control and quality of life than routine care; 2) assess whether the practice of providers assigned to the intervention group is more consistent with national clinical practice guidelines than that of control providers; 3) assess satisfaction of both patients and providers with this approach to management; and 4) assess marginal cost-effectiveness. | |||
Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms | Arm 1
Interventions:
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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 |
287 | |||
Original Enrollment ICMJE |
4000 | |||
Actual Study Completion Date | July 2007 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria: Providers:
Patients
Exclusion Criteria: Providers: - No participating patients Patients:
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Sex/Gender |
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Ages | 18 Years and older (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 | NCT00105664 | |||
Other Study ID Numbers ICMJE | IHI 02-062 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | VA Office of Research and Development | |||
Study Sponsor ICMJE | VA Office of Research and Development | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | VA Office of Research and Development | |||
Verification Date | October 2007 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |