A Personalized Prevention Program (PPP) Based on the Comprehensive Geriatric Assessment (CGA) for the Prevention of Multidimensional Frailty Related to Non-communicable Chronic Diseases (NCDs) in Older People: a Practical Approach in Primary Care Setting
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,216
- 试验地点
- 4
- 主要终点
- Hospitalization rate
研究概览
简要总结
- Non-Communicable Diseases (NCDs) can accelerated the aging process and increase the frailty condition
- The Comprehensive Geriatric Assessment (CGA) is the gold standard in the geriatric clinical context
- Recently, in Italy the first Guidelines about the CGA in different settings for older people has been pubblicated
- The CGA can identify older people at high risk of frailty who can benefit from a personalized prevention program
- No studies has been investigated the effects of a personalized prevention program (PPP) based on the CGA in a primary care setting
- The main hypothesis is that the CGA assessment can result in personalized prevention programs for older subjects in primary care settings with an effect in reducing the hospitalization rate and can be related to the biological paramters in NCDs
详细描述
The main aim of the project is to evaluate in older people the effectiveness of personalized preventive interventions based on the Comprehensive Geriatric Assessment (CGA) in the primary care setting and to explore biological process in Non-Communicable Disases (NCDs).
The study involves 1216 subjects enrolled by General Practitioners (GPs) in four different Italian Areas.
The GPs involved will be randomised to clusters in a 1:1 ratio, therefore one group of GPs will enrol patients for the Intervention Group and a second group of GPs will include patients for the Control Group.
The sample size:
A recent Cochrane systematic review reports a significant reduction in the risk of unplanned hospitalisation in community-dwelling elderly persons treated with VMD compared to standard clinical practice (RR= 0.83; CI 95%: 0.70-0.99). Thus, assuming an incidence of unplanned hospitalisations in one year of 38.8% in the group receiving PPP compared to 47.7% in the group randomised to standard care and assuming a power of 80% and a type I error of 5%, a total of 972 participants will be enrolled. Furthermore, assuming a drop-out rate of 20% over the 1-year follow-up period, the final sample will be 1216 participants, 608 in each group
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Care Provider)
盲法说明
The General Practitioners (GPs) involved will be randomised in clusters in a 1:1 ratio, therefore one group of GPs will enrol patients for the Intervention Group and a second group of GPs will include patients for the Control Group.
Therefore, the role of GPs are masked.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •65 years old and over
- •At least 1 non-communicable chronic disease
- •Signed informed consent
排除标准
- •not willing in partecipating in the study and no signed informed consent
- •<65 years old
- •without non-communicable chronic diseases
研究组 & 干预措施
Intervention Group
All the 608 patients will be evaluated by their General Practitioners through the Brief-MPI scale, which is based on the Comprehensive Geriatric Assessment (CGA).
Based on the score obtained at the Brief-MPI, the patient will receive a Personalised Prevention Program (PPP) concerning the following domains: 1) motor, 2) cognitive, 3) nutritional, 4) polypharmacotherapy, 5) vaccination prevention, 6) basal and instrumental activities, 7) co-habitation. Patients will receive brochures containing practical advice and recommendations to be implemented over a 12-month period; in the case of high Brief-MPI risk scores, patients will be referred for specialist examinations and/or in-depth diagnostics.
In addition, saliva samples will be collected to assess biomarkers of oxidative stress and, in a subsample of 210 subjects, the composition of the oral microbiota will also be analysed.
干预措施: Brief-MPI assessment (based on the Comprehensive Geriatric Assessment); Personalized Prevention Program (Combination Product)
Control group
Patients will receive the standard clinical practice by their General Practitioners, without being evaluated by the CGA or receiving the personalized prevention program (PPP). No saliva sample will be collected.
结局指标
主要结局
Hospitalization rate
时间窗: 12 months
Unplanned hospitalization rate
次要结局
- Composed outcome(6 and 12 months)
- Number of unplanned General Practitioners visits(12 months)
- Mortality rate(6 and 12 months)
研究者
Alberto Pilotto
Director of Department of Geriatric Care, Orthogeriatrics and Rehabilitation
Ente Ospedaliero Ospedali Galliera