Recognizing Osteoporosis and Its Consequences in Quebec (ROCQ) Programme
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00359047|
Recruitment Status : Active, not recruiting
First Posted : August 1, 2006
Last Update Posted : November 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Osteoporosis||Behavioral: Documentation Behavioral: Video||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2830 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Recognizing Osteoporosis and Its Consequences in Quebec (ROCQ) Programme|
|Study Start Date :||June 2003|
|Actual Primary Completion Date :||October 2007|
|Estimated Study Completion Date :||December 2025|
Written educational material on osteoporosis for the participant and the physician.
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
A 15-minute educational video on osteoporosis as well as written documentation on osteoporosis for the participant and the physician.
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
- The present diagnostic and treatment rates of osteoporosis 6 months after a fragility fracture [ Time Frame: June 2007 ]
- The osteoporosis diagnostic rate and on the osteoporosis pharmacological treatment rate 12 months after the educational interventions [ Time Frame: 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. [ Time Frame: July 2009 ]
- Changes of modifiable risk factors for osteoporosis 12 months after the intervention [ Time Frame: September 2009 ]
- Proportion of fragility versus traumatic fractures. [ Time Frame: June 2007 ]
- Health care resource utilization associated with specific types of fragility fracture and recurrent fractures. [ Time Frame: September 2010 ]
- Assess health utility index (EQ-5D) after a fragility fracture. [ Time Frame: September 2010 ]
- Satisfaction with the process of care before and after implementing ROCQ's interventions. [ Time Frame: June 2010 ]
- One-year mortality rate following a fragility fracture. [ Time Frame: May 2009 ]
- Persistence to pharmacological treatment 12 months after the intervention [ Time Frame: 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. [ Time Frame: November 2010 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00359047
|Quebec, Canada, G1V 4G2|
|Principal Investigator:||Jacques P Brown, MD||CHU de Quebec|