- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01745068
Partnership for Applied Research in Fracture Prevention Programs for the Elderly (OPTI-FRAC)
26 ottobre 2018 aggiornato da: 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.
Panoramica dello studio
Stato
Sconosciuto
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
631
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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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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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
50 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Nessun intervento: Gruppo di controllo
|
|
Sperimentale: 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.
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Incidence of secondary fragility fracture
Lasso di tempo: 18 months post recruitment
|
18 months post recruitment
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Initiation of osteoporosis treatment by the primary care physician
Lasso di tempo: 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.
Lasso di tempo: 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.
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At 6, 12, 18, and 60 months post recruitment
|
Time to first fall event
Lasso di tempo: Within the first 18 months post recruitment
|
Within the first 18 months post recruitment
|
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Incidence of secondary fragility fractures.
Lasso di tempo: At 24, 36, 48 and 60 months post recruitment
|
At 24, 36, 48 and 60 months post recruitment
|
|
Number of clinically significant fall events.
Lasso di tempo: At 18, 24, 36, 48 and 60 months post recruitment
|
At 18, 24, 36, 48 and 60 months post recruitment
|
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Fall-related hospitalizations
Lasso di tempo: 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
Lasso di tempo: 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).
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At 18, 24, 36, 48 and 60 months post recruitment
|
Participants' quality of life
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
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Admission to a long-term care facility
Lasso di tempo: At 18, 24, 36, 48 and 60 months post recruitment
|
At 18, 24, 36, 48 and 60 months post recruitment
|
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Participants' perceptions of care integration
Lasso di tempo: 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
Lasso di tempo: At 12 months post intervention
|
At 12 months post intervention
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Isabelle Gaboury, PhD, Université de Sherbrooke
- Investigatore principale: Hélène Corriveau, PhD pht, Université de Sherbrooke
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 gennaio 2013
Completamento primario (Effettivo)
1 novembre 2016
Completamento dello studio (Anticipato)
1 giugno 2019
Date di iscrizione allo studio
Primo inviato
5 dicembre 2012
Primo inviato che soddisfa i criteri di controllo qualità
5 dicembre 2012
Primo Inserito (Stima)
7 dicembre 2012
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
29 ottobre 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
26 ottobre 2018
Ultimo verificato
1 ottobre 2018
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CIHR grant # 267395
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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