A Study to Examine Health Behavior Change Strategies for Primary Care
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|ClinicalTrials.gov Identifier: NCT01323023|
Recruitment Status : Completed
First Posted : March 25, 2011
Last Update Posted : October 1, 2015
|Condition or disease||Intervention/treatment|
|Tobacco Use Risky Drinking Unhealthy Diet Physical Inactivity||Behavioral: varies by project|
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.
|Study Type :||Observational|
|Actual Enrollment :||4463 participants|
|Official Title:||Common Measures, Better Outcomes (COMBO)|
|Study Start Date :||June 2005|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
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 ClinicalTrials.gov identifier (NCT number): NCT01323023
|United States, Colorado|
|University of Colorado at Denver and Health Sciences Center|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Douglas H Fernald, MA||University of Colorado, Denver|