Partnership for Applied Research in Fracture Prevention Programs for the Elderly (OPTI-FRAC)
26 octobre 2018 mis à jour par: 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.
Aperçu de l'étude
Statut
Inconnue
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
631
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Quebec
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Amos, Quebec, Canada, J9T 2S2
- Centre hospitalier Hôtel-Dieu d'Amos
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Chandler, Quebec, Canada, G0C 1K0
- CSSS du Roché Percé (Centre hospitalier de Chandler)
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Gatineau, Quebec, Canada, J8Y 1W7
- Hôpital de Hull
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Greenfield Park, Quebec, Canada, J4V 2H1
- Hôpital Charles LeMoyne
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Montreal, Quebec, Canada, H1T 2M4
- Hopital Maisonneuve-Rosemont
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Montreal, Quebec, Canada, H4J 1C5
- Hôpital Sacré-Coeur de Montréal
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Montreal, Quebec, Canada, H2E1S6
- Hôpital Jean-Talon
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Saint-Charles-Borromée, Quebec, Canada, J6E 6J2
- Centre hospitalier régional de Lanaudière
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Sherbrooke, Quebec, Canada, J1H5N4
- Centre Hospitalier Universitaire de Sherbrooke
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St-Jérôme, Quebec, Canada, J7Z 5T3
- CSSS de St-Jérôme (Hôpital régional de St-Jérôme)
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
50 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Aucune intervention: Groupe de contrôle
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Expérimental: 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.
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Incidence of secondary fragility fracture
Délai: 18 months post recruitment
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18 months post recruitment
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Initiation of osteoporosis treatment by the primary care physician
Délai: At 6, 12, 18, and 60 months post recruitment
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Osteoporosis treatment includes bisphosphonates or other effective osteoporosis drugs.
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At 6, 12, 18, and 60 months post recruitment
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Compliance with osteoporosis treatment.
Délai: At 6, 12, 18, and 60 months post recruitment
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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.
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At 6, 12, 18, and 60 months post recruitment
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Time to first fall event
Délai: Within the first 18 months post recruitment
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Within the first 18 months post recruitment
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Incidence of secondary fragility fractures.
Délai: At 24, 36, 48 and 60 months post recruitment
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At 24, 36, 48 and 60 months post recruitment
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Number of clinically significant fall events.
Délai: At 18, 24, 36, 48 and 60 months post recruitment
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At 18, 24, 36, 48 and 60 months post recruitment
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Fall-related hospitalizations
Délai: At 18, 24, 36, 48 and 60 months post recruitment
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Fall-related hospitalizations will be recorded in the participant diary and at each telephone follow-up, and validated with the participant's hospital records.
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At 18, 24, 36, 48 and 60 months post recruitment
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Fragility fracture-related death
Délai: At 18, 24, 36, 48 and 60 months post recruitment
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Fragility fracture-related death will be confirmed from a provincial administrative database (Regie de l'assurance maladie du Quebec - RAMQ).
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At 18, 24, 36, 48 and 60 months post recruitment
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Participants' quality of life
Délai: At 18, 24, 36, 48 and 60 months post recruitment
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Euro-QOL
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At 18, 24, 36, 48 and 60 months post recruitment
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Practice of physical activities
Délai: At 6, 12, 18, 24, 36, 48 and 60 months post recruitment
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CHAMPS
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At 6, 12, 18, 24, 36, 48 and 60 months post recruitment
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Fragility fracture-related costs
Délai: At 18 and 60 months post recruitment
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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.
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At 18 and 60 months post recruitment
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Admission to a long-term care facility
Délai: At 18, 24, 36, 48 and 60 months post recruitment
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At 18, 24, 36, 48 and 60 months post recruitment
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Participants' perceptions of care integration
Délai: At 12 months post intervention
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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.
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At 12 months post intervention
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Intervention participant's satisfaction with the fragility fracture prevention program
Délai: At 12 months post intervention
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At 12 months post intervention
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Isabelle Gaboury, PhD, Université de Sherbrooke
- Chercheur principal: Hélène Corriveau, PhD pht, Université de Sherbrooke
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 janvier 2013
Achèvement primaire (Réel)
1 novembre 2016
Achèvement de l'étude (Anticipé)
1 juin 2019
Dates d'inscription aux études
Première soumission
5 décembre 2012
Première soumission répondant aux critères de contrôle qualité
5 décembre 2012
Première publication (Estimation)
7 décembre 2012
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
29 octobre 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
26 octobre 2018
Dernière vérification
1 octobre 2018
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CIHR grant # 267395
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .