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Sponsors and Collaborators: |
Centre hospitalier universitaire de Québec Merck Frosst Canada Ltd. Sanofi-Aventis Procter and Gamble Eli Lilly and Company Novartis |
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Information provided by: | Centre hospitalier universitaire de Québec |
ClinicalTrials.gov Identifier: | NCT00359047 |
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.
Condition | Intervention |
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Osteoporosis |
Behavioral: Control Group Behavioral: Written documentation on osteoporosis group Behavioral: Written documentation on osteoporosis and video group |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Recognizing Osteoporosis and Its Consequences in Quebec (ROCQ) Programme |
Enrollment: | 2830 |
Study Start Date: | June 2003 |
Estimated Study Completion Date: | October 2008 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Control: No Intervention
No educational intervention.
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Behavioral: Control Group
No specific intervention other than the interest raised by the questionnaires.
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Documentation: Experimental
Written educational material on osteoporosis for the participant and the physician.
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Behavioral: Written documentation on osteoporosis group
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
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Video: Experimental
15-minute educational video on osteoporosis as well as written documentation on osteoporosis for the participant and the physician.
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Behavioral: Written documentation on osteoporosis and video group
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
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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.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada | |
CHUQ, Pavillon CHUL | |
Quebec, Canada, G1V 4G2 |
Principal Investigator: | Jacques P Brown, MD | CHUQ, Pavillon CHUL |
Responsible Party: | Centre de recherche du CHUL ( Jacques Brown ) |
Study ID Numbers: | CHUL 61.05.05 |
Study First Received: | July 28, 2006 |
Last Updated: | May 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00359047 History of Changes |
Health Authority: | Canada: Health Canada |
Osteoporosis Fragility fracture Women Randomised control trial |
Patient education Diagnosis Treatment |
Musculoskeletal Diseases Fractures, Bone Osteoporosis Bone Diseases, Metabolic Bone Diseases |
Musculoskeletal Diseases Osteoporosis Bone Diseases, Metabolic Bone Diseases |