Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
4340 participants
OBSERVATIONAL
2008-03-31
2011-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Impact of Gut Microbiome on Metabolic and Bowel Function During the First Year After Spinal Cord Injury
NCT05670288
MicroRNA Regulation of Chronic Inflammation During Aging
NCT05392582
Associations Between the Microbiome, Skeletal Muscle Perfusion, and Fitness Status
NCT06009276
Michigan Medicine COVID-19 Cohort: Clinical Characteristics, Inflammatory Markers and Outcomes of Patients Hospitalized for COVID-19
NCT04706533
Chronic Inflammation and Exercise Responsiveness
NCT02732509
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Bravewell Collaborative
OTHER
Alliance Institute for Integrative Medicine
OTHER
Allina Health System
OTHER
Scripps Center for Integrative Medicine
OTHER
University of California, San Francisco
OTHER
University of Maryland
OTHER
The Continuum Center for Health and Healing
UNKNOWN
Thomas Jefferson University
OTHER
Venice Family Clinic
OTHER
Duke University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Bravewell Integrative Medicine Research Network (BraveNet)
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rowena Dolor, MD
Role: PRINCIPAL_INVESTIGATOR
Duke Clinical Research Institute
Ruth Wolever, PhD
Role: PRINCIPAL_INVESTIGATOR
Duke Integrative Medicine Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Scripps Center for Integrative Medicine
La Jolla, California, United States
Osher Center for Integrative Medicine
San Francisco, California, United States
Venice Family Clinic
Santa Monica, California, United States
University of Maryland Center for Integrative Medicine
Baltimore, Maryland, United States
Penny George Institute for Health and Healing
Minneapolis, Minnesota, United States
Duke Integrative Medicine
Durham, North Carolina, United States
Alliance Center for Integrative Medicine
Cincinnati, Ohio, United States
Jefferson-Myrna Brind Center of Integrative Medicine
Philadelphia, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Pro00006850
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.