Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00359047
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2017-11-21
First Post:
2006-07-28
Brief Title:
Recognizing Osteoporosis and Its Consequences in Quebec ROCQ Programme
Sponsor:
CHU de Quebec-Universite Laval
Organization:
CHU de Quebec-Universite Laval
Study Overview
Official Title:
Recognizing Osteoporosis and Its Consequences in Quebec ROCQ Programme
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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:
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 Quebecs drug plan databases
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 Quebecs drug plan databases
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None