Recognizing Osteoporosis and Its Consequences in Quebec (ROCQ) Programme
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,830
- 试验地点
- 2
- 主要终点
- The osteoporosis diagnostic rate and on the osteoporosis pharmacological treatment rate 12 months after the educational interventions
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Documentation
Written educational material on osteoporosis for the participant and the physician.
干预措施: Documentation (Behavioral)
Video
A 15-minute educational video on osteoporosis as well as written documentation on osteoporosis for the participant and the physician.
干预措施: Video (Behavioral)
结局指标
主要结局
The osteoporosis diagnostic rate and on the osteoporosis pharmacological treatment rate 12 months after the educational interventions
时间窗: 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.
时间窗: July 2009
The present diagnostic and treatment rates of osteoporosis 6 months after a fragility fracture
时间窗: June 2007
次要结局
- One-year mortality rate following a fragility fracture.(May 2009)
- Changes of modifiable risk factors for osteoporosis 12 months after the intervention(September 2009)
- Proportion of fragility versus traumatic fractures.(June 2007)
- Health care resource utilization associated with specific types of fragility fracture and recurrent fractures.(September 2010)
- Satisfaction with the process of care before and after implementing ROCQ's interventions.(June 2010)
- Incidence of recurrent fracture and health care resources utilization between women who previously had a fragility fracture and those who had a traumatic fracture.(November 2010)
- Assess health utility index (EQ-5D) after a fragility fracture.(September 2010)
- Persistence to pharmacological treatment 12 months after the intervention(October 2009)
研究者
Jacques Brown
Clinical researcher
CHU de Quebec-Universite Laval