Partnership for Applied Research in Fracture Prevention Programs for the Elderly (OPTI-FRAC)
2018年10月26日 更新者：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.
研究概览
研究类型
介入性
注册 (实际的)
631
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Quebec
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Amos、Quebec、加拿大、J9T 2S2
- Centre hospitalier Hôtel-Dieu d'Amos
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Chandler、Quebec、加拿大、G0C 1K0
- CSSS du Roché Percé (Centre hospitalier de Chandler)
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Gatineau、Quebec、加拿大、J8Y 1W7
- Hôpital de Hull
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Greenfield Park、Quebec、加拿大、J4V 2H1
- Hôpital Charles LeMoyne
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Montreal、Quebec、加拿大、H1T 2M4
- Hopital Maisonneuve-Rosemont
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Montreal、Quebec、加拿大、H4J 1C5
- Hôpital Sacré-Coeur de Montréal
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Montreal、Quebec、加拿大、H2E1S6
- Hôpital Jean-Talon
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Saint-Charles-Borromée、Quebec、加拿大、J6E 6J2
- Centre hospitalier régional de Lanaudière
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Sherbrooke、Quebec、加拿大、J1H5N4
- Centre Hospitalier Universitaire de Sherbrooke
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St-Jérôme、Quebec、加拿大、J7Z 5T3
- CSSS de St-Jérôme (Hôpital régional de St-Jérôme)
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
50年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：控制组
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实验性的：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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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Incidence of secondary fragility fracture
大体时间：18 months post recruitment
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18 months post recruitment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Initiation of osteoporosis treatment by the primary care physician
大体时间：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.
大体时间：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
大体时间：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.
大体时间：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.
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：At 12 months post intervention
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At 12 months post intervention
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Isabelle Gaboury, PhD、Université de Sherbrooke
- 首席研究员：Hélène Corriveau, PhD pht、Université de Sherbrooke
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年1月1日
初级完成 (实际的)
2016年11月1日
研究完成 (预期的)
2019年6月1日
研究注册日期
首次提交
2012年12月5日
首先提交符合 QC 标准的
2012年12月5日
首次发布 (估计)
2012年12月7日
研究记录更新
最后更新发布 (实际的)
2018年10月29日
上次提交的符合 QC 标准的更新
2018年10月26日
最后验证
2018年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.