BraveNet Integrative Medicine Descriptive Study (BraveNet)
12. juni 2011 oppdatert av: Duke University
BraveNet Multi-Center Integrative Medicine Survey
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.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
Specific Aims of BraveNet:
- 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.
Describe the patients seeking care at Integrative Medicine centers, in terms of:
- demographics, presenting symptoms, health conditions, type of care sought, and expectations for treatment;
- quality of life, mood, stress; and
- lifestyle factors.
- 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.].
- 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:
- Baseline Questionnaires - Demographics and reason for visit
- Quality of Life. The SF-12 (Short Form 12)
- Mood (Depression). The Center for Epidemiologic Studies Depression Scale (CES-D)
- Stress. The Perceived Stress Scale (PSS)
- Visual Analog Scales (VAS). Four self-report VASs will be used to measure aspects of pain, fatigue and restfulness of sleep.
- 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.
Studietype
Observasjonsmessig
Registrering (Faktiske)
4340
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
California
-
La Jolla, California, Forente stater, 92037
- Scripps Center for Integrative Medicine
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San Francisco, California, Forente stater, 94143
- Osher Center for Integrative Medicine
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Santa Monica, California, Forente stater, 90405
- Venice Family Clinic
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Maryland
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Baltimore, Maryland, Forente stater, 21207
- University of Maryland Center for Integrative Medicine
-
-
Minnesota
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Minneapolis, Minnesota, Forente stater, 55407
- Penny George Institute for Health and Healing
-
-
North Carolina
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Durham, North Carolina, Forente stater, 27710
- Duke Integrative Medicine
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-
Ohio
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Cincinnati, Ohio, Forente stater, 45236
- Alliance Center for Integrative Medicine
-
-
Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19107
- Jefferson-Myrna Brind Center of Integrative Medicine
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
500 patients from each of the nine participating Integrative Medicine Centers who are seeing any type of clinicial on the day of their visit.
Beskrivelse
Inclusion Criteria:
Subjects will be eligible for inclusion in this study only if all of the following criteria apply:
- Age: At least 18 years of age.
- Patient Status: Participants are eligible if seen individually by any type of clinician on the day of the visit.
- 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:
- 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.
- Inability to read and write in English or Spanish.
- Participating only in educational Center activities, not as a clinical patient.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Tverrsnitt
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
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.
Tidsramme: Once per patient
|
Once per patient
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
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.
Tidsramme: Once all surveys have been entered into the EDC system
|
Once all surveys have been entered into the EDC system
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Rowena Dolor, MD, Duke Clinical Research Institute
- Hovedetterforsker: Ruth Wolever, PhD, Duke Integrative Medicine Center
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mars 2008
Primær fullføring (Faktiske)
1. juni 2011
Studiet fullført (Faktiske)
1. juni 2011
Datoer for studieregistrering
Først innsendt
9. mars 2008
Først innsendt som oppfylte QC-kriteriene
9. mars 2008
Først lagt ut (Anslag)
14. mars 2008
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
14. juni 2011
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. juni 2011
Sist bekreftet
1. juni 2011
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- Pro00006850
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .