Clinical trial NCT00636779: BraveNet Integrative Medicine Descriptive Study
Official title: BraveNet Multi-Center Integrative Medicine Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: The Bravewell Collaborative
name: Alliance Institute for Integrative Medicine
name: Allina Health System
name: Scripps Center for Integrative Medicine
name: University of California, San Francisco
name: University of Maryland
name: The Continuum Center for Health and Healing
name: Thomas Jefferson University
name: Venice Family Clinic
First posted: 2008-03-14
Enrollment: 4340
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Primary outcomes:
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.
timeFrame: Once per patient
Secondary outcomes:
measure: 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.
timeFrame: Once all surveys have been entered into the EDC system
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Center for Integrative Medicine
state: California
city: San Francisco
country: United States
facility: Osher Center for Integrative Medicine
state: California
city: Santa Monica
country: United States
facility: Venice Family Clinic
state: California
city: Baltimore
country: United States
facility: University of Maryland Center for Integrative Medicine
state: Maryland
city: Minneapolis
country: United States
facility: Penny George Institute for Health and Healing
state: Minnesota
city: Durham
country: United States
facility: Duke Integrative Medicine
state: North Carolina
city: Cincinnati
country: United States
facility: Alliance Center for Integrative Medicine
state: Ohio
city: Philadelphia
country: United States
facility: Jefferson-Myrna Brind Center of Integrative Medicine
state: Pennsylvania
Study officials:
affiliation: Duke Clinical Research Institute
name: Rowena Dolor, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke Integrative Medicine Center
name: Ruth Wolever, PhD
role: PRINCIPAL_INVESTIGATOR
References: