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A Study to Examine Health Behavior Change Strategies for Primary Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01323023
Recruitment Status : Completed
First Posted : March 25, 2011
Last Update Posted : October 1, 2015
Robert Wood Johnson Foundation
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
Prescription for Health is a national program of The Robert Wood Johnson Foundation (RWJF) in collaboration with the Agency for Healthcare Research and Quality (AHRQ). A major goal of Prescription for Health is to measure the extent to which comprehensive strategies are effective in changing patient behavior and quality of life relative to four target health risk behaviors: diet, smoking, alcohol use, and physical activity. The funded projects will use a common set of survey instruments to help measure outcomes and draw overarching conclusions across projects. This study will only be analyzing aggregated data and does not have responsibility for recruitment of patients, randomization (if applicable), or interventions. Individual project designs may differ.

Condition or disease Intervention/treatment
Tobacco Use Risky Drinking Unhealthy Diet Physical Inactivity Behavioral: varies by project

Detailed Description:

The data will be collected by and submitted from up to 10 practice-based research networks over a two-year period. We will: 1) aggregate de-identified data and 2) analyze the aggregated data. We will not identify or recruit study subjects, administer surveys to patients, or conduct any interventions with patients or practices. The individual research networks will submit only de-identified data to a central data repository for subsequent analysis by us. Individual research networks will submit their own protocols for review by their IRBs in order to collect patient-specific data, conduct interventions, and submit de-identified data to our central repository.

By combining data from funded projects we will be able to answer questions that individual projects would not be able to answer. The analysis will use the combined set of data to gain statistical power sufficient to test hypotheses of interest, determine the distribution of responses to the selected measures in patients in primary care practices, assess the impact of types of interventions, compare the impact of different types of interventions, determine if these measures can be used routinely, and conclude how useful, if at all, the selected measures were in Prescription for Health projects. Statistical analysis will include basic descriptive statistics and distributions of scores at baseline and follow-up and more complex hierarchical linear modeling, which seeks to understand effects in multi-site studies (across sites or groups of sites). We will not directly evaluate specific research network interventions, but will assess them as part of larger groups. This study will report only aggregated results and will not name individual primary care practices or research networks.

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Study Type : Observational
Actual Enrollment : 4463 participants
Time Perspective: Prospective
Official Title: Common Measures, Better Outcomes (COMBO)
Study Start Date : June 2005
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adults, adolescents, and children in primary care practices.

Inclusion Criteria:

  • varies by project

Exclusion Criteria:

  • varies by project

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01323023

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United States, Colorado
University of Colorado at Denver and Health Sciences Center
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Robert Wood Johnson Foundation
Agency for Healthcare Research and Quality (AHRQ)
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Principal Investigator: Douglas H Fernald, MA University of Colorado, Denver
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Responsible Party: University of Colorado, Denver Identifier: NCT01323023    
Other Study ID Numbers: 05-0484
First Posted: March 25, 2011    Key Record Dates
Last Update Posted: October 1, 2015
Last Verified: September 2015