Recognizing Osteoporosis and Its Consequences in Quebec (ROCQ) Programme

Laval University

Status

Active, not recruiting

Conditions

Osteoporosis

Treatments

Behavioral: Video

Behavioral: Documentation

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00359047

CHUL 61.05.05

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,830 patients

Sex

Female

Ages

50+ years old

Volunteers

No Healthy Volunteers

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.