Partnership for Applied Research in Fracture Prevention Programs for the Elderly (OPTI-FRAC)
2018년 10월 26일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
631
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Quebec
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Amos, Quebec, 캐나다, J9T 2S2
- Centre hospitalier Hôtel-Dieu d'Amos
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Chandler, Quebec, 캐나다, G0C 1K0
- CSSS du Roché Percé (Centre hospitalier de Chandler)
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Gatineau, Quebec, 캐나다, J8Y 1W7
- Hôpital de Hull
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Greenfield Park, Quebec, 캐나다, J4V 2H1
- Hopital Charles LeMoyne
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Montreal, Quebec, 캐나다, H1T 2M4
- Hopital Maisonneuve-Rosemont
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Montreal, Quebec, 캐나다, H4J 1C5
- Hopital Sacre-Coeur de Montreal
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Montreal, Quebec, 캐나다, H2E1S6
- Hôpital Jean-Talon
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Saint-Charles-Borromée, Quebec, 캐나다, J6E 6J2
- Centre Hospitalier Régional de Lanaudière
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Sherbrooke, Quebec, 캐나다, J1H5N4
- Centre Hospitalier Universitaire de Sherbrooke
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St-Jérôme, Quebec, 캐나다, J7Z 5T3
- CSSS de St-Jérôme (Hôpital régional de St-Jérôme)
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
50년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: 대조군
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Incidence of secondary fragility fracture
기간: 18 months post recruitment
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18 months post recruitment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Initiation of osteoporosis treatment by the primary care physician
기간: 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.
기간: 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
기간: 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.
기간: 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.
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: At 12 months post intervention
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At 12 months post intervention
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
수사관
- 수석 연구원: Isabelle Gaboury, PhD, Université de Sherbrooke
- 수석 연구원: Hélène Corriveau, PhD pht, Université de Sherbrooke
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2013년 1월 1일
기본 완료 (실제)
2016년 11월 1일
연구 완료 (예상)
2019년 6월 1일
연구 등록 날짜
최초 제출
2012년 12월 5일
QC 기준을 충족하는 최초 제출
2012년 12월 5일
처음 게시됨 (추정)
2012년 12월 7일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 10월 29일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 10월 26일
마지막으로 확인됨
2018년 10월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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