Recognizing Osteoporosis and Its Consequences in Quebec (ROCQ) Programme

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Centre Hospitalier Universitaire de Québec, CHU de Québec.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Merck Frosst Canada Ltd.
Sanofi
Procter and Gamble
Eli Lilly and Company
Novartis
Information provided by (Responsible Party):
Jacques Brown, Centre hospitalier universitaire de Québec
ClinicalTrials.gov Identifier:
NCT00359047
First received: July 28, 2006
Last updated: October 20, 2011
Last verified: October 2011
  Purpose

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
Osteoporosis
Behavioral: Control Group
Behavioral: Written documentation on osteoporosis group
Behavioral: Written documentation on osteoporosis and video group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Recognizing Osteoporosis and Its Consequences in Quebec (ROCQ) Programme

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Québec, CHU de Québec:

Primary Outcome Measures:
  • The present diagnostic and treatment rates of osteoporosis 6 months after a fragility fracture [ Time Frame: June 2007 ] [ Designated as safety issue: No ]
  • The osteoporosis diagnostic rate and on the osteoporosis pharmacological treatment rate 12 months after the educational interventions [ Time Frame: June 2007 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes of modifiable risk factors for osteoporosis 12 months after the intervention [ Time Frame: September 2009 ] [ Designated as safety issue: No ]
  • Proportion of fragility versus traumatic fractures. [ Time Frame: June 2007 ] [ Designated as safety issue: No ]
  • Health care resource utilization associated with specific types of fragility fracture and recurrent fractures. [ Time Frame: September 2010 ] [ Designated as safety issue: No ]
  • Assess health utility index (EQ-5D) after a fragility fracture. [ Time Frame: September 2010 ] [ Designated as safety issue: No ]
  • Satisfaction with the process of care before and after implementing ROCQ's interventions. [ Time Frame: June 2010 ] [ Designated as safety issue: No ]
  • One-year mortality rate following a fragility fracture. [ Time Frame: May 2009 ] [ Designated as safety issue: No ]
  • Persistence to pharmacological treatment 12 months after the intervention [ Time Frame: October 2009 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 2830
Study Start Date: June 2003
Estimated Study Completion Date: March 2013
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
No educational intervention.
Behavioral: Control Group
No specific intervention other than the interest raised by the questionnaires.
Experimental: Documentation
Written educational material on osteoporosis for the participant and the physician.
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
Experimental: Video
15-minute educational video on osteoporosis as well as written documentation on osteoporosis for the participant and the physician.
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

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 Quebec's drug plan databases.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00359047

Locations
Canada
CHUQ, Pavillon CHUL
Quebec, Canada, G1V 4G2
Sponsors and Collaborators
Centre Hospitalier Universitaire de Québec, CHU de Québec
Merck Frosst Canada Ltd.
Sanofi
Procter and Gamble
Eli Lilly and Company
Novartis
Investigators
Principal Investigator: Jacques P Brown, MD CHUQ, Pavillon CHUL
  More Information

Publications:
Responsible Party: Jacques Brown, Clinical researcher, Centre hospitalier universitaire de Québec
ClinicalTrials.gov Identifier: NCT00359047     History of Changes
Other Study ID Numbers: CHUL 61.05.05
Study First Received: July 28, 2006
Last Updated: October 20, 2011
Health Authority: Canada: Health Canada

Keywords provided by Centre Hospitalier Universitaire de Québec, CHU de Québec:
Osteoporosis
Fragility fracture
Women
Randomised control trial
Patient education
Diagnosis
Treatment

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 20, 2014