Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

BraveNet Integrative Medicine Descriptive Study (BraveNet)

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.
ClinicalTrials.gov Identifier: NCT00636779
Recruitment Status : Completed
First Posted : March 14, 2008
Last Update Posted : June 14, 2011
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

Tracking Information
First Submitted Date March 9, 2008
First Posted Date March 14, 2008
Last Update Posted Date June 14, 2011
Study Start Date March 2008
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 9, 2008)
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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00636779 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 9, 2008)
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 ]
Original Secondary Outcome Measures Same as current
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title BraveNet Integrative Medicine Descriptive Study
Official Title BraveNet Multi-Center Integrative Medicine Survey
Brief Summary 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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Healthy
Intervention Not Provided
Study 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 12, 2011)
4340
Original Estimated Enrollment
 (submitted: March 9, 2008)
4000
Actual Study Completion Date June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00636779
Other Study ID Numbers Pro00006850
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Rowena Dolor, Coordinating Principal Investigator, Bravewell Integrative Medicine Research Network (BraveNet)
Study Sponsor Duke University
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
Investigators
Principal Investigator: Rowena Dolor, MD Duke Clinical Research Institute
Principal Investigator: Ruth Wolever, PhD Duke Integrative Medicine Center
PRS Account Duke University
Verification Date June 2011