Recognizing Osteoporosis and Its Consequences in Quebec (ROCQ) Programme

Study Overview
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Brief Summary
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The aim of the ROCQ programme is to improve the use of evidence based osteoporosis diagnostic and treatment strategies for women 50 years and over who have suffered a fragility fracture. This objective will be achieved by concentrating on a realistic evaluation of the present diagnosis and treatment rate of osteoporosis following a fragility fracture and comparing it to an optimal situation (care gap) and proposing interventions that promote new approaches to treating osteoporosis by health professionals as well as providing targeted interventions for the patient. The efficacy of these interventions will be evaluated using a randomized control design.

Detailed Description
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ROCQ is a patient health-management programme and prospective cohort study. Within the ROCQ programme, educational interventions to improve osteoporosis management will be evaluated using a randomized-control design. The programme is composed of a promotional campaign, three main phases and a 20-year follow-up. At phase 1, 0 to 16 weeks after the fracture, participants with fragility and traumatic fractures will be recruited and will be asked information regarding their fracture. At phase 2, 6 to 8 months after the fracture, all participants will complete questionnaires to evaluate demographic and clinical features, risk factors for osteoporosis, co-morbidities, status of diagnosis and treatment, and the EQ-5D. The current medical management of osteoporosis (or the care gap in diagnosis and treatment) will be measured using this questionnaire at phase 2. Once the phase 2 questionnaire has been completed, Only participants with fragility fractures will be randomized to one of the three following educational intervention groups: 1) the Educational Video Group, 2) the Documentation Group, or 3) the Control Group. At phase 3, 12 to 14 months after randomization, the effectiveness of the interventions will be assessed by re-administering the questionnaires to participants who experienced a fragility fracture at baseline. The questionnaires evaluate the status of diagnosis and treatment of osteoporosis, modifiable risk factors and the health-related quality of life (EQ-5D). The impact of the interventions on the participants will be assessed by comparing diagnosis and treatments rates in each intervention arm. If the long-term viability of the programme is secured, participants with fragility and traumatic fractures will be followed for a maximum period of 20 years using specific encoded personal data contained in the RAMQ and Quebec's drug plan databases.

Official Title
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Recognizing Osteoporosis and Its Consequences in Quebec (ROCQ) Programme

Conditions
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Osteoporosis

Intervention / Treatment
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* Behavioral: Documentation
* Behavioral: Video


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female, aged 50 years and over. Not residing in a long-term care hospital before the fracture. Able to understand the programme information and consent form. Must voluntarily accept to participate in this programme and sign the consent form. Participants must have a fragility or traumatic fracture of one of the following sites: wrist, forearm, humerus, scapula, clavicle, sternum, thoracic or lumbar vertebrae, pelvis, sacrum, hip, femur, proximal and distal tibia, fibula (including ankle), and foot. Participants must be able to answer the questionnaires via phone interviews Exclusion Criteria: Unable to understand the purpose of the programme. Participants with a traumatic fracture of one of the following sites: cervical, skull and face, hand and finger, toe, metatarsus, and patella. Pathological fracture. Women currently participating in a clinical trial requiring them to take a medication for osteoporosis.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Documentation<br>Written educational material on osteoporosis for the participant and the physician. | Behavioral: Documentation<br>* Participants will receive written educational material for themselves as well as the Guidelines document for their physician (same written material as in the Educational Video Group). They will be asked to revisit their physician and provide written documentation inviting him/her to consider a complementary investigation and an adequate treatment according to the 2002 Clinical Practice Guidelines for the Diagnosis and Management of Osteoporosis in Canada<br>|
| Experimental: Video<br>A 15-minute educational video on osteoporosis as well as written documentation on osteoporosis for the participant and the physician. | Behavioral: Video<br>* Participants will receive a 15-minute educational video on osteoporosis. They will also receive written educational material for themselves and a Guidelines document for their physician. They will be asked to revisit their physician and provide the written documentation inviting her/him to consider a complementary investigation and an adequate treatment according to the 2002 Clinical Practice Guidelines for the Diagnosis and Management of Osteoporosis in Canada. Should participants wish to obtain additional information on osteoporosis, they will be provided with a toll-free number (1-866-571-ROCQ) to contact<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The present diagnostic and treatment rates of osteoporosis 6 months after a fragility fracture |  | June 2007 | 
| The osteoporosis diagnostic rate and on the osteoporosis pharmacological treatment rate 12 months after the educational interventions |  | June 2007 | 
| The average 5-year, 10-year, 15-year, and 20-year probabilities of a fragility fracture by age, site of previous fragility fracture, and type of ROCQ intervention. |  | July 2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of modifiable risk factors for osteoporosis 12 months after the intervention |  | September 2009 | 
| Proportion of fragility versus traumatic fractures. |  | June 2007 | 
| Health care resource utilization associated with specific types of fragility fracture and recurrent fractures. |  | September 2010 | 
| Assess health utility index (EQ-5D) after a fragility fracture. |  | September 2010 | 
| Satisfaction with the process of care before and after implementing ROCQ's interventions. |  | June 2010 | 
| One-year mortality rate following a fragility fracture. |  | May 2009 | 
| Persistence to pharmacological treatment 12 months after the intervention |  | October 2009 | 
| Incidence of recurrent fracture and health care resources utilization between women who previously had a fragility fracture and those who had a traumatic fracture. |  | November 2010 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoporosis, Fragility fracture, Women, Randomised control trial, Patient education, Diagnosis, Treatment