Partnership for Applied Research in Fracture Prevention Programs for the Elderly (OPTI-FRAC)
26 de outubro de 2018 atualizado por: 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.
Visão geral do estudo
Status
Desconhecido
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
631
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Quebec
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Amos, Quebec, Canadá, J9T 2S2
- Centre hospitalier Hôtel-Dieu d'Amos
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Chandler, Quebec, Canadá, G0C 1K0
- CSSS du Roché Percé (Centre hospitalier de Chandler)
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Gatineau, Quebec, Canadá, J8Y 1W7
- Hôpital de Hull
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Greenfield Park, Quebec, Canadá, J4V 2H1
- Hôpital Charles LeMoyne
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Montreal, Quebec, Canadá, H1T 2M4
- Hopital Maisonneuve-Rosemont
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Montreal, Quebec, Canadá, H4J 1C5
- Hopital Sacre-Coeur de Montreal
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Montreal, Quebec, Canadá, H2E1S6
- Hôpital Jean-Talon
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Saint-Charles-Borromée, Quebec, Canadá, J6E 6J2
- Centre hospitalier régional de Lanaudière
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Sherbrooke, Quebec, Canadá, J1H5N4
- Centre Hospitalier Universitaire de Sherbrooke
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St-Jérôme, Quebec, Canadá, J7Z 5T3
- CSSS de St-Jérôme (Hôpital régional de St-Jérôme)
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
50 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Sem intervenção: Grupo de controle
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Experimental: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Incidence of secondary fragility fracture
Prazo: 18 months post recruitment
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18 months post recruitment
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Initiation of osteoporosis treatment by the primary care physician
Prazo: 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.
Prazo: 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
Prazo: 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.
Prazo: 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.
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: At 12 months post intervention
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At 12 months post intervention
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Isabelle Gaboury, PhD, Université de Sherbrooke
- Investigador principal: Hélène Corriveau, PhD pht, Université de Sherbrooke
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de janeiro de 2013
Conclusão Primária (Real)
1 de novembro de 2016
Conclusão do estudo (Antecipado)
1 de junho de 2019
Datas de inscrição no estudo
Enviado pela primeira vez
5 de dezembro de 2012
Enviado pela primeira vez que atendeu aos critérios de CQ
5 de dezembro de 2012
Primeira postagem (Estimativa)
7 de dezembro de 2012
Atualizações de registro de estudo
Última Atualização Postada (Real)
29 de outubro de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
26 de outubro de 2018
Última verificação
1 de outubro de 2018
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CIHR grant # 267395
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