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.
調査の概要
研究の種類
介入
入学 (実際)
631
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Quebec
-
Amos、Quebec、カナダ、J9T 2S2
- Centre hospitalier Hôtel-Dieu d'Amos
-
Chandler、Quebec、カナダ、G0C 1K0
- CSSS du Roché Percé (Centre hospitalier de Chandler)
-
Gatineau、Quebec、カナダ、J8Y 1W7
- Hôpital de Hull
-
Greenfield Park、Quebec、カナダ、J4V 2H1
- Hopital Charles LeMoyne
-
Montreal、Quebec、カナダ、H1T 2M4
- Hopital Maisonneuve-Rosemont
-
Montreal、Quebec、カナダ、H4J 1C5
- Hopital Sacre-Coeur de Montreal
-
Montreal、Quebec、カナダ、H2E1S6
- Hôpital Jean-Talon
-
Saint-Charles-Borromée、Quebec、カナダ、J6E 6J2
- Centre Hospitalier Régional de Lanaudière
-
Sherbrooke、Quebec、カナダ、J1H5N4
- Centre Hospitalier Universitaire de Sherbrooke
-
St-Jérôme、Quebec、カナダ、J7Z 5T3
- CSSS de St-Jérôme (Hôpital régional de St-Jérôme)
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
50年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：対照群
|
|
|
実験的：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.
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Incidence of secondary fragility fracture
時間枠：18 months post recruitment
|
18 months post recruitment
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Initiation of osteoporosis treatment by the primary care physician
時間枠：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.
時間枠：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
時間枠：Within the first 18 months post recruitment
|
Within the first 18 months post recruitment
|
|
|
Incidence of secondary fragility fractures.
時間枠：At 24, 36, 48 and 60 months post recruitment
|
At 24, 36, 48 and 60 months post recruitment
|
|
|
Number of clinically significant fall events.
時間枠：At 18, 24, 36, 48 and 60 months post recruitment
|
At 18, 24, 36, 48 and 60 months post recruitment
|
|
|
Fall-related hospitalizations
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：At 12 months post intervention
|
At 12 months post intervention
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
協力者
捜査官
- 主任研究者：Isabelle Gaboury, PhD、Université de Sherbrooke
- 主任研究者：Hélène Corriveau, PhD pht、Université de Sherbrooke
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2013年1月1日
一次修了 (実際)
2016年11月1日
研究の完了 (予想される)
2019年6月1日
試験登録日
最初に提出
2012年12月5日
QC基準を満たした最初の提出物
2012年12月5日
最初の投稿 (見積もり)
2012年12月7日
学習記録の更新
投稿された最後の更新 (実際)
2018年10月29日
QC基準を満たした最後の更新が送信されました
2018年10月26日
最終確認日
2018年10月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Integrated programの臨床試験
-
Bekasi City Public HospitalUniversity of Groningen完了
-
Northwestern UniversityUniversity of Michigan; The University of Texas Health Science Center at San Antonio; University... と他の協力者完了
-
Children's Health積極的、募集していない
-
Brown UniversityHarvard University; West Virginia University; Canandaigua VA Medical Center; The Warren Alpert Foundation募集
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI); The City College of New York; Ralph Lauren Center for Cancer... と他の協力者募集
-
Florida International UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)完了
-
University of LiverpoolLondon School of Hygiene and Tropical Medicine; National Institute of Mental Health (NIMH)完了