Partnership for Applied Research in Fracture Prevention Programs for the Elderly (OPTI-FRAC)
|ClinicalTrials.gov Identifier: NCT01745068|
Recruitment Status : Active, not recruiting
First Posted : December 7, 2012
Last Update Posted : November 25, 2016
|Condition or disease||Intervention/treatment||Phase|
|Osteoporosis With Current Fragility Fracture||Other: Integrated program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||631 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Partnership for Applied Research in Fracture Prevention Programs for the Elderly|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||November 2016|
|Estimated Study Completion Date :||June 2019|
|No Intervention: Control group|
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.
Other: 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.
- Incidence of secondary fragility fracture [ Time Frame: 18 months post recruitment ]
- Initiation of osteoporosis treatment by the primary care physician [ Time Frame: At 6, 12, 18, and 60 months post recruitment ]Osteoporosis treatment includes bisphosphonates or other effective osteoporosis drugs.
- Compliance with osteoporosis treatment. [ Time Frame: 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.
- Time to first fall event [ Time Frame: Within the first 18 months post recruitment ]
- Incidence of secondary fragility fractures. [ Time Frame: At 24, 36, 48 and 60 months post recruitment ]
- Number of clinically significant fall events. [ Time Frame: At 18, 24, 36, 48 and 60 months post recruitment ]
- Fall-related hospitalizations [ Time Frame: 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.
- Fragility fracture-related death [ Time Frame: 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).
- Participants' quality of life [ Time Frame: At 18, 24, 36, 48 and 60 months post recruitment ]Euro-QOL
- Practice of physical activities [ Time Frame: At 6, 12, 18, 24, 36, 48 and 60 months post recruitment ]CHAMPS
- Fragility fracture-related costs [ Time Frame: 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.
- Admission to a long-term care facility [ Time Frame: At 18, 24, 36, 48 and 60 months post recruitment ]
- Participants' perceptions of care integration [ Time Frame: 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.
- Intervention participant's satisfaction with the fragility fracture prevention program [ Time Frame: At 12 months post intervention ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01745068
|Centre hospitalier Hôtel-Dieu d'Amos|
|Amos, Quebec, Canada, J9T 2S2|
|CSSS du Roché Percé (Centre hospitalier de Chandler)|
|Chandler, Quebec, Canada, G0C 1K0|
|Hôpital de Hull|
|Gatineau, Quebec, Canada, J8Y 1W7|
|Hôpital Charles Lemoyne|
|Greenfield Park, Quebec, Canada, J4V 2H1|
|Montreal, Quebec, Canada, H1T 2M4|
|Montreal, Quebec, Canada, H2E1S6|
|Hôpital Sacré-Coeur de Montréal|
|Montreal, Quebec, Canada, H4J 1C5|
|Centre hospitalier régional de Lanaudière|
|Saint-Charles-Borromée, Quebec, Canada, J6E 6J2|
|Centre Hospitalier Universitaire de Sherbrooke|
|Sherbrooke, Quebec, Canada, J1H5N4|
|CSSS de St-Jérôme (Hôpital régional de St-Jérôme)|
|St-Jérôme, Quebec, Canada, J7Z 5T3|
|Principal Investigator:||Isabelle Gaboury, PhD||Université de Sherbrooke|
|Principal Investigator:||Hélène Corriveau, PhD pht||Université de Sherbrooke|