- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00596674
Health Promotion for Women With Fibromyalgia
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This wellness intervention, originally developed and tested in a randomized clinical trial of women with MS (N=113), resulted in significant improvements in self-efficacy, health behaviors and improvements in pain, social functioning, mental health and emotional role-functioning. The specific aims of this study are to examine the effects of the adapted wellness intervention on self-efficacy, resources, barriers, health behaviors and health outcomes for women with fibromyalgia.
A sample of 160 women with FMS will be recruited to participate in a randomized clinical study to determine the effects of this wellness intervention that includes an eight week health promotion/behavior change component and 3 months of follow-up phone support. Content regarding stress management, lifestyle adjustment, physical activity, nutrition and women's health issues will be presented with an emphasis on the unique adaptations and associated skills required to empower women with the tools for exercising personal control over their health behaviors. The effects of the intervention on outcome variables will be assessed over an 8-month period with measurements at baseline, 2 months (immediately after the educational/skill-building component), 5 months (after 3 months of phone support) and at 8 months.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Texas
-
Austin, Texas, Forente stater, 78701
- The University of Texas at Austin
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Female
- Physician verified diagnosis of Fibromyalgia for at least 6 months, age 18 to 75,
- Able to speak and read English
- Willing to participate in 8-month intervention study
Exclusion Criteria:
- Pregnancy
- Male
- Concurrent medical conditions (as judged by their physician) for which changes in diet and exercise would be contraindicated
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Lifestyle Counts Intervention
A wellness intervention that includes 8 weeks of behavior change classes focused on acquiring the skills and knowledge to improve health behaviors (e.g., exercise, stress management), followed by 3 months of phone support.
|
8 weeks of classes focused on health behavior change, individualized goal setting and 3 months of follow-up phone support
|
Placebo komparator: Attention Countrol
8 weeks of general health classes followed by phone calls for 3 months
|
8 weeks of classes on general health information topics followed by 3 months of phone calls to solicit questions
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
SF36 Subscales
Tidsramme: Baseline, 2 months, 5 months and 8 months
|
Baseline, 2 months, 5 months and 8 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Fibromyalgia Impact Questionnaire
Tidsramme: Baseline, 2 months, 5 months, 8 months
|
Baseline, 2 months, 5 months, 8 months
|
Health Behaviors - The Health Promoting Lifestyle Questionnaire
Tidsramme: Baseline, 2 months, 5 months 8 months
|
Baseline, 2 months, 5 months 8 months
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Alexa Stuifbergen, PhD, RN, The University of Texas at Austin School of Nursing
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2002-08-0043
- R01HD035047 (U.S. NIH-stipend/kontrakt)
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. .
Kliniske studier på Fibromyalgi
-
University of AberdeenFullførtFibromyalgi | Fibromyalgi, primær | Fibromyalgi, sekundærStorbritannia
-
Eli Lilly and CompanyFullførtFibromyalgi, primær | Fibromyalgi, sekundærMexico
-
Rasmia ElgoharyHar ikke rekruttert ennå
-
Yousra Hisham Abdel FattahFullførtFibromyalgi, primærEgypt
-
Forest LaboratoriesCypress Bioscience, Inc.AvsluttetPrimær fibromyalgiForente stater
-
Universidade Federal do Rio Grande do NorteFullført
-
Tonix Pharmaceuticals, Inc.FullførtPrimær fibromyalgiForente stater
-
Tonix Pharmaceuticals, Inc.FullførtPrimær fibromyalgiForente stater
-
University of ManitobaFullført
Kliniske studier på Lifestyle Counts
-
Postgraduate Institute of Dental Sciences RohtakRekrutteringAntall mikrokjernerIndia
-
Seoul National University Bundang HospitalFullførtGenerell anestesi | Laparoskopi | Nevromuskulær blokadeKorea, Republikken
-
Mayo ClinicNational Cancer Institute (NCI)FullførtPapillomavirusvaksinerForente stater