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Health Promotion for Women With Fibromyalgia

24. april 2012 opdateret af: University of Texas at Austin
Women with chronic disabling conditions such as fibromyalgia syndrome (FMS) must manage a wide variety of disease-related, intrapersonal, and environmental demands to maintain their health and quality of life. Engaging in health-promoting behaviors is one strategy recommended to manage disease symptoms and enhance quality of life (USDHHS, 2000). The purpose of this four-year study is to refine and test a theoretically and empirically based intervention to promote the health and well being of women with the chronic disabling condition of fibromyalgia. We hypothesize that women who participate in the "Lifestyle Counts" Intervention will report more greater self-efficacy for health behaviors, more frequent health behaviors and more positive health and quality of life than women in the comparison group.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

177

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Texas
      • Austin, Texas, Forenede Stater, 78701
        • The University of Texas at Austin

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: Lifestyle Counts
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
Andet: Attention Control
8 weeks of classes on general health information topics followed by 3 months of phone calls to solicit questions

Hvad måler undersøgelsen?

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Texas at Austin

Samarbejdspartnere

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Efterforskere

  • Ledende efterforsker: Alexa Stuifbergen, PhD, RN, The University of Texas at Austin School of Nursing

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2003

Primær færdiggørelse (Faktiske)

1. januar 2007

Studieafslutning (Faktiske)

1. maj 2008

Datoer for studieregistrering

Først indsendt

8. januar 2008

Først indsendt, der opfyldte QC-kriterier

8. januar 2008

Først opslået (Skøn)

17. januar 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

25. april 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. april 2012

Sidst verificeret

1. april 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2002-08-0043
  • R01HD035047 (U.S. NIH-bevilling/kontrakt)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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