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BraveNet Integrative Medicine Descriptive Study

This study has been completed.
Sponsor:
Collaborators:
The Bravewell Collaborative
Alliance Institute for Integrative Medicine
Allina Hospitals and Clinics
Scripps Center for Integrative Medicine
University of California, San Francisco
University of Maryland
The Continuum Center for Health and Healing
Thomas Jefferson University
Venice Family Clinic
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT00636779
First received: March 9, 2008
Last updated: June 12, 2011
Last verified: June 2011
  Purpose

The Bravewell Integrative Medicine Research Network (BraveNet) is a newly formed practice-based research network of nine leading integrative medicine centers around the U.S. collaborating in clinical outcomes research to increase the knowledge and evidence-base of integrative medicine.


Condition
Healthy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: BraveNet Multi-Center Integrative Medicine Survey

Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 4340
Study Start Date: March 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
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.

Detailed Description:

Specific Aims of BraveNet:

  1. 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.
  2. Describe the patients seeking care at Integrative Medicine centers, in terms of:

    1. demographics, presenting symptoms, health conditions, type of care sought, and expectations for treatment;
    2. quality of life, mood, stress; and
    3. lifestyle factors.
  3. 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.].
  4. 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.

Measures:

  1. Baseline Questionnaires - Demographics and reason for visit
  2. Quality of Life. The SF-12 (Short Form 12)
  3. Mood (Depression). The Center for Epidemiologic Studies Depression Scale (CES-D)
  4. Stress. The Perceived Stress Scale (PSS)
  5. Visual Analog Scales (VAS). Four self-report VASs will be used to measure aspects of pain, fatigue and restfulness of sleep.
  6. 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

500 patients from each of the nine participating Integrative Medicine Centers who are seeing any type of clinicial on the day of their visit.

Criteria

Inclusion Criteria:

  • Subjects will be eligible for inclusion in this study only if all of the following criteria apply:

    1. Age: At least 18 years of age.
    2. Patient Status: Participants are eligible if seen individually by any type of clinician on the day of the visit.
    3. English or Spanish Literacy: Ability to read and write English or Spanish as confirmed by the site personnel and ability to provide informed consent.

Exclusion Criteria:

  • Subjects will be excluded from this study if any of the following criteria apply:

    1. Cognitive Impairment: A subject will not be eligible if he/she has a history of psychiatric disease, dementia, Alzheimer's disease, or other conditions which will limit the validity of providing informed consent to participate in the study.
    2. Inability to read and write in English or Spanish.
    3. Participating only in educational Center activities, not as a clinical patient.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00636779

Locations
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
Sponsors and Collaborators
Duke University
The Bravewell Collaborative
Alliance Institute for Integrative Medicine
Allina Hospitals and Clinics
Scripps Center for Integrative Medicine
University of California, San Francisco
University of Maryland
The Continuum Center for Health and Healing
Thomas Jefferson University
Venice Family Clinic
Investigators
Principal Investigator: Rowena Dolor, MD Duke Clinical Research Institute
Principal Investigator: Ruth Wolever, PhD Duke Integrative Medicine Center
  More Information

No publications provided

Responsible Party: Rowena Dolor, Coordinating Principal Investigator, Bravewell Integrative Medicine Research Network (BraveNet)
ClinicalTrials.gov Identifier: NCT00636779     History of Changes
Other Study ID Numbers: Pro00006850
Study First Received: March 9, 2008
Last Updated: June 12, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 20, 2014