Determining Feasibility of a Model of Care for Secondary Fracture Prevention for Implementation in Health Care System in Pakistan After Hip Fracture: a Clinical Outcome Study
试验速览
- 阶段
- 不适用
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Secondary fracture prevention of hip
研究概览
简要总结
Osteoporosis is a disorder of low bone mass and micro-architectural deterioration resulting in decreased mechanical strength and increased susceptibility to fractures even after minimal trauma. These 'minimal trauma fractures' (also known as 'osteoporotic', 'low trauma' or 'fragility' fractures) are the hallmark of a chronic and disabling disease that affects both men and women worldwide. On statistical grounds, more than 50 % of postmenopausal women and 30 % of men over the age of 60 years will suffer at least one minimal trauma fracture during their remaining lifetime. Any osteoporotic fracture predisposes to further fractures, significant morbidity and premature death. Thus, following a first minimal trauma fracture both men and women have a two- to threefold increased risk of subsequent fracture.
This study aims to determine feasibility of evaluating different models of care through a structured multidisciplinary path tailored to identify, assess and treat hip fracture patients in an effective timely manner that are at high risk of subsequent fracture (Type A model) and to compare its effectiveness and feasibility with a type B, C & D model as proposed by Ganda et al at the Aga Khan University, with collaboration of the departments of Orthopaedics, Chemical Pathology, Family Medicine and Internal Medicine.
详细描述
With the severity of implications associated with fragility fractures, prevention of a secondary fracture has become a primary focus from a patient care and societal standpoint worldwide. However, this area has been so far neglected in Pakistan. A fracture requires that two conditions occur simultaneously: week bones and a fall or stress on week bones and a co-management approach is required to address both issues.
The investigators propose to determine feasibility of evaluating different models of care through a structured multidisciplinary path tailored to identify, assess and treat hip fracture patients in an effective timely manner that are at high risk of subsequent fracture (Type A model) and to compare its effectiveness and feasibility with a type B, C & D model as proposed by Ganda et al. Based on this study the investigators will propose a model of care for SFP for application at national level in private and public sector. The long-term plan is to develop a national fragility fracture network in preventing and managing fragility fractures and to promote research aimed at better treatments of osteoporosis, sarcopenia and fracture in line with global CtA from FFN. This information will also help us in applying clinical practice guidelines for osteoporosis and driving policy change for our country which is currently non-existent and is likely to be a step towards the achievement of Sustainable Development Goals (SDG) (i.e. ensure healthy lives and promote wellbeing for all at all ages) and in line with WHO decade of healthy ageing 2021-23.
Specific Aims:
This study is primarily aimed at comparison of the feasibility and effectiveness of models of care (Type A, B, C & D) for hip fracture patients. The Specific, Measurable, Achievable, Realistic, and Time-defined (SMART) goals of this project are formulated around the 5IQ approach delineated by the Royal Osteoporosis society based on the following 6 parameters.
I. Identification: systematic screening of high-risk individuals
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All women ≥50 years with low trauma hip fracture
- •All post-menopausal women ( less than 50 years) with low trauma hip fracture
- •Men ≥50 years with low trauma hip fracture
排除标准
- •Patients with high impact hip fracture including after road traffic accident
结局指标
主要结局
Secondary fracture prevention of hip
时间窗: 1 year of follow-up
Rate of Secondary fracture of hip (occurrence of hip fracture (n) if any during the follow up will be noted)
Total Secondary fracture prevention
时间窗: 1 year of follow-up
Rate of total fracture (occurrence of fracture (n), if any, during the follow up will be noted)
次要结局
- Effectiveness of the models of care- Communication(1 year of follow-up)
- Effectiveness of the models of care- Follow up plan(1 year of follow-up)
- Effectiveness of the models of care- Care provided post fracture(1 year of follow-up)
- Effectiveness of the models of care- Adequacy of information provided(1 year of follow-up)
研究者
Sibtain Ahmed
Assistant Professor
Aga Khan University