Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Partnership for Applied Research in Fracture Prevention Programs for the Elderly (OPTI-FRAC)

26. oktober 2018 opdateret af: Isabelle Gaboury, Université de Sherbrooke
During their lifetime, approximately 50% of Canadian women and 30% of Canadian men will experience at least one fracture due to bone fragility (FF). Evidence is growing regarding prevention programs' effectiveness to prevent falls, but prevention of fractures through fall prevention programs has enjoyed limited success. Falls prevention programs and post-fracture screening programs leading to pharmacological treatment are very different strategies, with a shared ultimate goal. Coordination between those who repair fractures and those who manage the patient to prevent the next fracture is critical. The overarching aim of this proposal is to generate evidence-based knowledge about the effectiveness and cost-effectiveness of an integrated FF prevention program, as well as a portrait of the barriers and facilitating factors for such programs. More specifically, the objectives are: 1) to combine existing fall prevention and post-fracture management programs in the province of Quebec into integrated FF prevention programs; 2) to compare the performance of these integrated programs to control sites, using a pragmatic study design; 3) to identify barriers as well as factors that improve effectiveness across different implementation milieu; and 4) to develop and engage in active knowledge transfer activities in Quebec regions where integrated FF prevention programs are neither adequately nor successfully implemented. Drawing upon the literature on integrated healthcare, fall and fracture prevention, we hypothesize that an integrated FF program can reduce the risk of a subsequent fracture by at least 30% in the population of interest. The proposed team is poised to develop new interdisciplinary collaborations among healthcare practitioners and decision makers involved in the prevention of FFs. The program is built upon existing healthcare and structures and programs and in turn, will truly measure the effectiveness of an integrated FF prevention program. The results will ultimately lead to improvements in the existing knowledge base, address policy-relevant and health systems problems, and assist in the design and implementation of FFs prevention programs.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

631

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Canada
    • Quebec
      • Amos, Quebec, Canada, J9T 2S2
        • Centre hospitalier Hôtel-Dieu d'Amos
      • Chandler, Quebec, Canada, G0C 1K0
        • CSSS du Roché Percé (Centre hospitalier de Chandler)
      • Gatineau, Quebec, Canada, J8Y 1W7
        • Hôpital de Hull
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Hopital Charles LeMoyne
      • Montreal, Quebec, Canada, H1T 2M4
        • Hôpital Maisonneuve-Rosemont
      • Montreal, Quebec, Canada, H4J 1C5
        • Hopital Sacre-Coeur de Montreal
      • Montreal, Quebec, Canada, H2E1S6
        • Hôpital Jean-Talon
      • Saint-Charles-Borromée, Quebec, Canada, J6E 6J2
        • Centre hospitalier régional de Lanaudière
      • Sherbrooke, Quebec, Canada, J1H5N4
        • Centre Hospitalier Universitaire de Sherbrooke
      • St-Jérôme, Quebec, Canada, J7Z 5T3
        • CSSS de St-Jérôme (Hôpital régional de St-Jérôme)

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

50 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • 50 years of age and over
  • must have a primary care physician
  • must be able to follow simple instructions
  • must have sustained a fragility fracture within three months of the recruitment date.

Exclusion Criteria:

  • severe kidney insufficiency (grade 4 or 5)
  • advanced stage of cancer
  • fracture to sites not commonly associated with osteoporosis such as toe, finger, hand, foot, ankle, patella, head, and cervical spine.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Kontrolgruppe
Eksperimentel: Integrated program
Participants will be involved in an integrated interorganisational fragility fracture prevention program, which combines both post-fracture management as well as fall prevention strategies. The intervention will last up to 18 months.
Andet: Integrated program
Each participant's primary care physician will receive written information containing a presumed osteoporosis diagnosis, investigations to be performed, correct interpretation of any bone densitometry results in the context of a fragility fracture, and treatment options. The study coordinator will be responsible for orienting the participant to an appropriate local fall prevention program.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Incidence of secondary fragility fracture
Tidsramme: 18 months post recruitment
18 months post recruitment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Initiation of osteoporosis treatment by the primary care physician
Tidsramme: At 6, 12, 18, and 60 months post recruitment
Osteoporosis treatment includes bisphosphonates or other effective osteoporosis drugs.
At 6, 12, 18, and 60 months post recruitment
Compliance with osteoporosis treatment.
Tidsramme: At 6, 12, 18, and 60 months post recruitment
The data collected from the participant will be validated with the participant's pharmacist through the medication possession ratio. The medication possession ratio is measured from the first to the last prescription, with the denominator being the duration from index to the exhaustion of the last prescription and the numerator being the days supplied over that period from first to last prescription and the numerator being the total number of days in the interval.
At 6, 12, 18, and 60 months post recruitment
Time to first fall event
Tidsramme: Within the first 18 months post recruitment
Within the first 18 months post recruitment
Incidence of secondary fragility fractures.
Tidsramme: At 24, 36, 48 and 60 months post recruitment
At 24, 36, 48 and 60 months post recruitment
Number of clinically significant fall events.
Tidsramme: At 18, 24, 36, 48 and 60 months post recruitment
At 18, 24, 36, 48 and 60 months post recruitment
Fall-related hospitalizations
Tidsramme: At 18, 24, 36, 48 and 60 months post recruitment
Fall-related hospitalizations will be recorded in the participant diary and at each telephone follow-up, and validated with the participant's hospital records.
At 18, 24, 36, 48 and 60 months post recruitment
Fragility fracture-related death
Tidsramme: At 18, 24, 36, 48 and 60 months post recruitment
Fragility fracture-related death will be confirmed from a provincial administrative database (Regie de l'assurance maladie du Quebec - RAMQ).
At 18, 24, 36, 48 and 60 months post recruitment
Participants' quality of life
Tidsramme: At 18, 24, 36, 48 and 60 months post recruitment
Euro-QOL
At 18, 24, 36, 48 and 60 months post recruitment
Practice of physical activities
Tidsramme: At 6, 12, 18, 24, 36, 48 and 60 months post recruitment
CHAMPS
At 6, 12, 18, 24, 36, 48 and 60 months post recruitment
Fragility fracture-related costs
Tidsramme: At 18 and 60 months post recruitment
Medical costs from the participant's hospital record include: medical assessment, prescription and non-prescription drugs; and resource use related to the management of the fragility fracture and/or long-term complications, including hospitalization. As well, lost days of work, annual income (if the participant is in the labour force), travel to the hospital and/or rehabilitation facilities, parking, and out-of-pocket expenses for drugs and rehabilitation devices (e.g. splint) will be compiled. Protocol-driven costs will be excluded, with the exception of the costs related to the participants' fall prevention program.
At 18 and 60 months post recruitment
Admission to a long-term care facility
Tidsramme: At 18, 24, 36, 48 and 60 months post recruitment
At 18, 24, 36, 48 and 60 months post recruitment
Participants' perceptions of care integration
Tidsramme: At 12 months post intervention
All participants' perceptions of care integration will be captured 12 months after the beginning of the intervention period, or following an early withdrawal from the study.
At 12 months post intervention
Intervention participant's satisfaction with the fragility fracture prevention program
Tidsramme: At 12 months post intervention
At 12 months post intervention

Samarbejdspartnere og efterforskere

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

Sponsor

Université de Sherbrooke

Samarbejdspartnere

Merck Sharp & Dohme LLC
Novartis
Canadian Institutes of Health Research (CIHR)
Amgen
Ministere de la Sante et des Services Sociaux
CSSS-IUGS Estrie

Efterforskere

  • Ledende efterforsker: Isabelle Gaboury, PhD, Universite de Sherbrooke
  • Ledende efterforsker: Hélène Corriveau, PhD pht, Universite de Sherbrooke

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. januar 2013

Primær færdiggørelse (Faktiske)

1. november 2016

Studieafslutning (Forventet)

1. juni 2019

Datoer for studieregistrering

Først indsendt

5. december 2012

Først indsendt, der opfyldte QC-kriterier

5. december 2012

Først opslået (Skøn)

7. december 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. oktober 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. oktober 2018

Sidst verificeret

1. oktober 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CIHR grant # 267395

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 Integrated program

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Peru

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner