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Partnership for Applied Research in Fracture Prevention Programs for the Elderly (OPTI-FRAC)

26 de octubre de 2018 actualizado 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.

Descripción general del estudio

Estado

Desconocido

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

631

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Canadá
    • Quebec
      • Amos, Quebec, Canadá, J9T 2S2
        • Centre hospitalier Hôtel-Dieu d'Amos
      • Chandler, Quebec, Canadá, G0C 1K0
        • CSSS du Roché Percé (Centre hospitalier de Chandler)
      • Gatineau, Quebec, Canadá, J8Y 1W7
        • Hôpital de Hull
      • Greenfield Park, Quebec, Canadá, J4V 2H1
        • Hopital Charles LeMoyne
      • Montreal, Quebec, Canadá, H1T 2M4
        • Hôpital Maisonneuve-Rosemont
      • Montreal, Quebec, Canadá, H4J 1C5
        • Hopital Sacre-Coeur de Montreal
      • Montreal, Quebec, Canadá, H2E1S6
        • Hôpital Jean-Talon
      • Saint-Charles-Borromée, Quebec, Canadá, J6E 6J2
        • Centre Hospitalier Régional de Lanaudière
      • Sherbrooke, Quebec, Canadá, J1H5N4
        • Centre Hospitalier Universitaire de Sherbrooke
      • St-Jérôme, Quebec, Canadá, J7Z 5T3
        • CSSS de St-Jérôme (Hôpital régional de St-Jérôme)

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

50 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Investigación de servicios de salud
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Grupo de control
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.
Otro: Integrated program
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Incidence of secondary fragility fracture
Periodo de tiempo: 18 months post recruitment
18 months post recruitment

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Initiation of osteoporosis treatment by the primary care physician
Periodo de tiempo: 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.
Periodo de tiempo: 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
Periodo de tiempo: Within the first 18 months post recruitment
Within the first 18 months post recruitment
Incidence of secondary fragility fractures.
Periodo de tiempo: At 24, 36, 48 and 60 months post recruitment
At 24, 36, 48 and 60 months post recruitment
Number of clinically significant fall events.
Periodo de tiempo: At 18, 24, 36, 48 and 60 months post recruitment
At 18, 24, 36, 48 and 60 months post recruitment
Fall-related hospitalizations
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: At 12 months post intervention
At 12 months post intervention

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Université de Sherbrooke

Colaboradores

Merck Sharp & Dohme LLC
Novartis
Canadian Institutes of Health Research (CIHR)
Amgen
Ministere de la Sante et des Services Sociaux
CSSS-IUGS Estrie

Investigadores

  • Investigador principal: Isabelle Gaboury, PhD, Université de Sherbrooke
  • Investigador principal: Hélène Corriveau, PhD pht, Université de Sherbrooke

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de enero de 2013

Finalización primaria (Actual)

1 de noviembre de 2016

Finalización del estudio (Anticipado)

1 de junio de 2019

Fechas de registro del estudio

Enviado por primera vez

5 de diciembre de 2012

Primero enviado que cumplió con los criterios de control de calidad

5 de diciembre de 2012

Publicado por primera vez (Estimar)

7 de diciembre de 2012

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

29 de octubre de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

26 de octubre de 2018

Última verificación

1 de octubre de 2018

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CIHR grant # 267395

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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