CClinicalTrials.gg
CompletedNCT00636779BraveNetUpdated Jun 14, 2011

BraveNet Integrative Medicine Descriptive Study

An observational study in Healthy, sponsored by Duke University. Completed at 8 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-06-14.

Sponsored by Duke University · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
4,340
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.

Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
4,340 participants (actual)

Groups and 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.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

07

Study locations

8 sites
  • Scripps Center for Integrative Medicine
    La Jolla, California 92037, United States
  • Osher Center for Integrative Medicine
    San Francisco, California 94143, United States
  • Venice Family Clinic
    Santa Monica, California 90405, United States
  • University of Maryland Center for Integrative Medicine
    Baltimore, Maryland 21207, United States
  • Penny George Institute for Health and Healing
    Minneapolis, Minnesota 55407, United States
  • Duke Integrative Medicine
    Durham, North Carolina 27710, United States
  • Alliance Center for Integrative Medicine
    Cincinnati, Ohio 45236, United States
  • Jefferson-Myrna Brind Center of Integrative Medicine
    Philadelphia, Pennsylvania 19107, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00636779
Lead sponsor
Duke University
Collaborators
The Bravewell Collaborative, Alliance Institute for Integrative Medicine, Allina Health System, 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
First posted
Mar 14, 2008
Start date
Mar 2008
Primary completion
Jun 2011
Completion
Jun 2011
Last update
Jun 14, 2011

Study contacts

Rowena Dolor, MD
principal investigator · Duke Clinical Research Institute
Ruth Wolever, PhD
principal investigator · Duke Integrative Medicine Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion