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BraveNet Integrative Medicine Descriptive Study
This study is not yet open for participant recruitment.
Study NCT00636779   Information provided by Duke University
First Received: March 9, 2008   Last Updated: March 17, 2008   History of Changes

March 9, 2008
March 17, 2008
March 2008
October 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00636779 on ClinicalTrials.gov Archive Site
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 ]
Same as current
 
BraveNet Integrative Medicine Descriptive Study
BraveNet Multi-Center Integrative Medicine Survey

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

Specific Aims of BraveNet:

  1. Demonstrate feasibility for the eight 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.

Five hundred eligible patients seen in a three to six month period at each of the eight 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.
 
Observational
Cohort, Cross-Sectional
Healthy
 
Five hundred eligible patients seen in a three to six month period at each of the eight 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.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Not yet recruiting
4000
December 2008
October 2008   (final data collection date for primary outcome measure)

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 Literacy: Ability to read and write English 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.
    3. Participating only in educational Center activities, not as a clinical patient.
Both
18 Years and older
Yes
Contact: Gayle E Paynter, RN, MBA/MHA 919-668-8641 gayle.e.paynter@duke.edu
United States
 
NCT00636779
Gayle Paynter, Project Leader, Bravewell Integrative Medicine Research Netowork (BraveNet)
Pro00006850
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
  • Jefferson-Myrna Brind Center of Integrative Medicine
Principal Investigator: Rowena Dolor, MD Duke University
Principal Investigator: Ruth Wolever, PhD Duke Integrative Medicine Center
Duke University
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP