BraveNet Integrative Medicine Descriptive Study (BraveNet)
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|ClinicalTrials.gov Identifier: NCT00636779|
Recruitment Status : Completed
First Posted : March 14, 2008
Last Update Posted : June 14, 2011
|Condition or disease|
Specific Aims of BraveNet:
- Demonstrate feasibility for the nine sites of BraveNet to coordinate in specifying data elements, developing and implementing smooth data collection procedures, analyzing the data, publishing and disseminating the results through scientific conferences and journals.
Describe the patients seeking care at Integrative Medicine centers, in terms of:
- demographics, presenting symptoms, health conditions, type of care sought, and expectations for treatment;
- quality of life, mood, stress; and
- lifestyle factors.
- Explore potential patterns within the sample [e.g., do the survey scores vary by demographics, by condition, by type patient (new vs return), by type of help sought, etc.].
- Utilize above data as pilot data for future studies and funding opportunities.
Up to five hundred eligible patients seen at each of the nine participating Centers will be approached (by mail, phone, at the time of their visit, etc.) and invited to consent to the paper and pencil study. The patient survey will clearly state that participation is voluntary with a written consent to participate on the front. Individual practices will report the response rate in order to monitor the potential effect of volunteer bias. Participant completion of questionnaires should take 15 to 30 minutes, and should be completed within 2 weeks of the patient visit., The corresponding provider form will be completed by the provider/research staff within 5 days of the visit.
- Baseline Questionnaires - Demographics and reason for visit
- Quality of Life. The SF-12 (Short Form 12)
- Mood (Depression). The Center for Epidemiologic Studies Depression Scale (CES-D)
- Stress. The Perceived Stress Scale (PSS)
- Visual Analog Scales (VAS). Four self-report VASs will be used to measure aspects of pain, fatigue and restfulness of sleep.
- Provider Form. Providers/ Research Staff will complete this form to indicate the type of provider seen, the CPT codes used to describe/bill for the service, the services provided, and the provider's assessment of current medical conditions/co-morbidities.
|Study Type :||Observational|
|Actual Enrollment :||4340 participants|
|Official Title:||BraveNet Multi-Center Integrative Medicine Survey|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
Up to five hundred eligible patients seen at each of the nine participating Integrative Medicine Centers will be approached (by mail, phone, at the time of their visit, etc.) and invited to consent to the paper and pencil study.
- Describe the patients seeking care at Integrative Medicine centers, in terms of:a.demographics, presenting symptoms, health conditions, type of care sought, and expectations for treatment; b.quality of life, mood, stress; and c.lifestyle factors. [ Time Frame: Once per patient ]
- Explore potential patterns within the sample [e.g., do the survey scores vary by demographics, by condition, by type patient (new vs return), by type of help sought, etc.]and utilize data as pilot data for future studies and funding opportunities. [ Time Frame: Once all surveys have been entered into the EDC system ]
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): NCT00636779
|United States, California|
|Scripps Center for Integrative Medicine|
|La Jolla, California, United States, 92037|
|Osher Center for Integrative Medicine|
|San Francisco, California, United States, 94143|
|Venice Family Clinic|
|Santa Monica, California, United States, 90405|
|United States, Maryland|
|University of Maryland Center for Integrative Medicine|
|Baltimore, Maryland, United States, 21207|
|United States, Minnesota|
|Penny George Institute for Health and Healing|
|Minneapolis, Minnesota, United States, 55407|
|United States, North Carolina|
|Duke Integrative Medicine|
|Durham, North Carolina, United States, 27710|
|United States, Ohio|
|Alliance Center for Integrative Medicine|
|Cincinnati, Ohio, United States, 45236|
|United States, Pennsylvania|
|Jefferson-Myrna Brind Center of Integrative Medicine|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Rowena Dolor, MD||Duke Clinical Research Institute|
|Principal Investigator:||Ruth Wolever, PhD||Duke Integrative Medicine Center|