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A Direct-to-patient Intervention to Increase Rates of Osteoporosis Care (APROPOS)

29. maj 2018 opdateret af: Kenneth Saag, MD, MSc, University of Alabama at Birmingham

Activating Patients to Reduce OsteoPOrosiS

The purpose of this study is to conduct a randomized trial of a tailored intervention designed to provide personalized feedback regarding patients' risk of subsequent fractures, customized information regarding osteoporosis care, and messaging to activate patients to become more engaged in improving osteoporosis treatment and doctor-patient communication. This novel content will use "story-telling" delivered via the Internet and digital video discs (DVDs). The content will be uniquely tailored to each person based on barriers to care, age and race/ethnicity. We will conduct a controlled, cluster-randomized trial of this intervention to determine differences in post-intervention rates of osteoporosis care between two randomization arms.

We hypothesize that participants randomized to the intervention arm, compared to those randomized to a control arm, will receive more osteoporosis care at 6 months post-intervention, as evidenced by higher rates of: (H1) Prescription osteoporosis therapies, (H2) Non-prescription therapy with calcium and vitamin D, and (H3) Bone mineral density (BMD) testing.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

2684

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
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35205
        • University of Alabama at Birmingham
    • California
      • Los Angeles, California, Forenede Stater, 90048
        • Cedars-Sinai Medical Center
    • Massachusetts
      • Worcester, Massachusetts, Forenede Stater, 01655
        • University of Massachusetts at Worcester
    • New York
      • New York, New York, Forenede Stater, 10016
        • New York University
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45236
        • Jewish Hospital of Cincinnati
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • University of Pittsburgh
    • Washington
      • Seattle, Washington, Forenede Stater, 98101
        • Group Health Research Institute

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

55 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • Self-reported history of fracture

Exclusion Criteria:

  • Self-reported current prescription osteoporosis treatment

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
Ingen indgriben: Sædvanlig pleje
Eksperimentel: Video-based intervention
Video-based intervention providing personalized feedback regarding patients' risk of subsequent fractures, customized information regarding osteoporosis care, and messaging to activate patients to become more engaged in improving osteoporosis treatment and doctor-patient communication. This novel content will use "story-telling" delivered via the Internet and DVDs. The content will be uniquely tailored to each person based on their reported barriers to care, age and race/ethnicity. The video-based intervention materials will be augmented by a personal phone call and interactive voice response messaging.
Adfærdsmæssigt: Video-based Intervention
Video clips delivered by DVD and Internet

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants That Initiate an Osteoporosis Prescription Medication
Tidsramme: 6 months post-intervention
We will assess the number of participants that self-report the initiation of an osteoporosis prescription medication. It will be assessed using a self-completed survey. Osteoporosis prescription medications that will be assessed include: alendronate, calcitonin, denosumab ibandronate, raloxifene, risedronate, teriparatide, and zoledronic acid. We will not include initiation of estrogen hormone therapies as part of the primary outcome.
6 months post-intervention

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants Who Reported Use of Calcium and Vitamin D
Tidsramme: 6 and 18 months post-intervention
We will assess the use of calcium and vitamin D by participant. This will be assessed on a self-completed survey. Participants will be asked if they are currently taking a calcium supplement and/or vitamin D supplement.
6 and 18 months post-intervention
Number of Participants Who Reported Receipt of Bone Mineral Density (BMD) Testing
Tidsramme: 6 and 18 months post-intervention
Self-report of a receipt of a DXA scan (Bone Mineral Density test).
6 and 18 months post-intervention
Number of Participants That Initiate an Osteoporosis Prescription Medication
Tidsramme: 18 months
We will assess the number of participants that self-report the initiation of an osteoporosis prescription medication. It will be assessed using a self-completed survey. Osteoporosis prescription medications that will be assessed include: alendronate, calcitonin, denosumab ibandronate, raloxifene, risedronate, teriparatide, and zoledronic acid. We will not include initiation of estrogen hormone therapies as part of the outcome.
18 months

Andre resultatmål

Resultatmål
Tidsramme
Number of Participants Who Reported Communicating With a Health Care Provider About Osteoporosis Care
Tidsramme: 6 and 18 months post-intervention
6 and 18 months post-intervention

Samarbejdspartnere og efterforskere

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

Sponsor

University of Alabama at Birmingham

Samarbejdspartnere

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
University of Pittsburgh
Cedars-Sinai Medical Center
Kaiser Permanente
University of Cincinnati
University of Massachusetts, Worcester
Helen Hayes Hospital

Efterforskere

  • Ledende efterforsker: Kenneth G Saag, MD, MSc, University of Alabama at Birmingham

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.

Generelle publikationer

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. august 2013

Primær færdiggørelse (Faktiske)

1. oktober 2015

Studieafslutning (Faktiske)

1. november 2016

Datoer for studieregistrering

Først indsendt

11. juli 2013

Først indsendt, der opfyldte QC-kriterier

18. juli 2013

Først opslået (Skøn)

24. juli 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. juni 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. maj 2018

Sidst verificeret

1. maj 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • X110928001
  • R01AR060240 (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 .

Kliniske forsøg med Video-based Intervention

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Sponsorer og samarbejdspartnere

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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