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GIOP Prevention Among People With Rheumatoid Arthritis

12. juni 2015 opdateret af: University of North Carolina, Chapel Hill

Osteoporosis Prevention Among People With Rheumatoid Arthritis Receiving Oral Glucocorticoid Therapy

The ultimate objective of the proposed research is to improve the health-related quality of life of individuals with rheumatoid arthritis by reducing their risk of developing osteoporosis secondary to glucocorticoid therapy. The study has four specific aims.

Specific Aim 1: To obtain descriptive information concerning patients' knowledge, beliefs and behaviors with respect to osteoporosis and osteoporosis prevention.

Specific Aim 2: To identify factors that discriminate among patients in different stages of change with respect to each behavior of interest.

Specific Aim 3: To compare the effects of tailored versus generic educational materials on patient adherence to the ACR Guidelines for the Prevention of Glucocorticoid-Induced Osteoporosis.

Specific Aim 4: To determine if the effects of tailored educational materials are enhanced by concurrent feedback of information concerning patients' behavioral risk factor status to their physicians.

Studieoversigt

Detaljeret beskrivelse

Therapy with oral glucocorticoids often plays an important role in the management of rheumatoid arthritis (RA). The American College of Rheumatology (ACR) Ad Hoc Committee on Clinical Guidelines recently concluded that glucocorticoids are highly effective in relieving symptoms among people with active RA and that these medications may retard the rate of joint damage. Despite these obvious benefits, therapy with oral glucocorticoids is a well-established risk factor for osteoporosis, as highlighted by the recently published ACR Guidelines on the Prevention of Glucocorticoid-induced Osteoporosis. The ultimate objective of the proposed research is to improve the health-related quality of life of individuals with RA by reducing their risk of developing osteoporosis secondary to glucocorticoid therapy. The study has four specific aims: (1) to obtain descriptive information concerning patients' knowledge, beliefs and behaviors with respect to osteoporosis and osteoporosis prevention; (2) to identify factors that discriminate among patients in different stages of change with respect to each behavior of interest; (3) to compare the effects of tailored versus generic educational materials on patient adherence to the ACR Guidelines for the Prevention Glucocorticoid-induced Osteoporosis; and (4) to determine if the effects of tailored educational materials is enhanced by concurrent feedback of information concerning patients' behavioral risk factor status to their physicians. A sample of 273 patients with RA currently taking an oral glucocorticoid were recruited to participate in the study. Data were collected via mailed questionnaires and telephone interviews. The study used an experimental research design. Following baseline data collection, participants were randomly assigned to one of four experimental groups. Patients in one group received standard care only. Patients in the second group received generic educational materials about osteoporosis and osteoporosis prevention in addition to standard care. Patients in the third group received educational materials tailored to their stage in the behavior change process in addition to standard care. Finally, patients in the fourth group received the same tailored educational materials and care received by patients in the third group. In addition, each patient's physician received feedback concerning the patient's status with respect to behavioral risk factors for osteoporosis (e.g., inadequate calcium intake). Follow-up data were collected one year after baseline data collection. Variables assessed included: (1) behavior, (2) stage of change, (3) knowledge and counseling received concerning osteoporosis, (4) health beliefs, (5) physical health status, (6) osteoporosis risk factors, (7) background characteristics, and (8) information seeking. To accomplish the specific aims of the study, data will be analyzed using descriptive statistics, multivariate analysis of variance, and discriminant analyses.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

273

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27599-7360
        • University of North Carolina at Chapel Hill School of Pharmacy

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Meet American College of Rheumatology criteria for rheumatoid arthritis
  • Taking an oral glucocorticoid equivalent to 5 mg/day of prednisone for at least one month prior to study entry
  • Age 18 or older

Exclusion Criteria:

  • Existing osteoporosis
  • Pregnancy
  • Breast feeding
  • History of breast cancer
  • Physician recommendation to limit calcium intake
  • Class IV rheumatoid arthritis

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Tailored Materials
Participants received written educational materials concerning each behavior targeted. The materials were tailored to the participants' stage of change with respect to each behavior.
Eksperimentel: Physician Feedback
Participants received written educational materials concerning each behavior targeted. The materials were tailored to the participant's stage of change with respect to each behavior. In additon, the participant's physician received information concerning the participant's status on each behavior targeted.
Aktiv komparator: Generic Materials
Participants received generic written educational materials about osteoporosis prevention.
Placebo komparator: Placebo Comparator
Participants receive no information
Participants received no informational materials.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Calcium Intake
Tidsramme: One Year
One Year
Vitamin D Intake
Tidsramme: One Year
One Year
Bone Mineral Density Testing
Tidsramme: One Year
One Year
Use of prophylactic medications (e.g., bisphosphonates)
Tidsramme: One Year
One Year

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Susan J. Blalock, PhD, University of North Carolina, Chapel Hill

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

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 2001

Studieafslutning (Faktiske)

1. februar 2006

Datoer for studieregistrering

Først indsendt

24. januar 2008

Først indsendt, der opfyldte QC-kriterier

24. januar 2008

Først opslået (Skøn)

7. februar 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. juni 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. juni 2015

Sidst verificeret

1. januar 2008

Mere information

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 .

Kliniske forsøg med Rheumatoid arthritis

Kliniske forsøg med Tailored Materials

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Abonner