FORMULA 100: an ICOPE-based Multidomain Intervention to Promote Active and Healthy Ageing.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- ICOPE-based program feasibility, operationalized as the study completion rate at 6 months.
研究概览
简要总结
FORMULA 100 is a prospective, single-arm feasibility study conducted at two Active Ageing Centers in Monza, Italy, involving community-dwelling adults aged 65 years and older. The study will test whether an Integrated Care for Older People (ICOPE)-based care pathway can be implemented in this setting.
Participants will first be screened for possible decline in intrinsic capacity (IC). Those enrolled will then undergo a multidimensional assessment and receive a personalized 3-month intervention tailored to their needs. The intervention may address physical, cognitive, nutritional, psychological, sensory, and social needs and may also include a review of medications.
Participants will be reassessed after 3 months and again after 6 months. The main study outcome is the proportion of participants who complete the 6-month follow-up. About 300 people are expected to be screened, with a target enrollment of 250 participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Age ≥ 65 years
- •Attendance at one of the Active Ageing Centers participating in the project
- •Evidence of impairment in at least one key domain of intrinsic capacity, as identified through the first-level ICOPE screening
- •Ability to walk independently (with or without a walking aid)
- •Ability to communicate and cooperate with the research team
排除标准
- •Clinical conditions precluding completion of the first-level ICOPE screening or safe participation in the study, including severe dementia, bilateral blindness, end-stage diseases (e.g., Child-Pugh class C liver cirrhosis, stage 5 chronic kidney disease, chronic obstructive pulmonary disease Global Initiative for Chronic Obstructive Lung Disease group D, end-stage heart failure, or advanced cancer)
- •Concurrent participation in another clinical study
- •Refusal or inability to provide written informed consent
研究组 & 干预措施
Multidomain intervention
干预措施: Multidomain intervention (Other)
结局指标
主要结局
ICOPE-based program feasibility, operationalized as the study completion rate at 6 months.
时间窗: 6 months
This retention rate is defined as the proportion of enrolled participants who complete the entire study pathway, with a prespecified feasibility target of ≥80%.
次要结局
- Prevalence of frailty(Baseline)
- Prevalence of IC-domain impairments(Baseline)
- Adherence to multidomain interventions(3 months)
- Participant satisfaction(3 months and 6 months)