Randomized Clinical Trial to Assess the Efficacy of an Educational Programme for Prevention and Treatment of Frailty in Older Adults Living in the Community: FRAGSALUD Programme
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 235
- 试验地点
- 2
- 主要终点
- Evaluation of the Change of Baseline Fried Frailty Criteria at 6 Months
研究概览
简要总结
Frailty is a condition with a high prevalence in older adults, leading to higher vulnerability and increasing the risk of adverse health outcomes and disabilities. The aging of the population in Spain is accelerating quickly, consequently, it is necessary to advise the population on the appropriate path to healthy aging, free of fragility and their secondary problems.
详细描述
To evaluate the efficacy and efficiency of a Fragsalud program for the prevention and multifactorial treatment of frailty in people over 65 years of age living in the community compared to the usual treatment. Material and methods: A Single blind randomized, two-arm clinical trial; control group and intervention group, multicenter, with 15 months of follow-up, with evaluations blinded at the beginning, and in the follow-up at 12 and 15 months. A recruitment of 196 people over 65 years of age with criteria of pre-frailty or frailty according to Fried's criteria. The Fragsalud education program will be taught in the intervention group; while control group will follow the usual health care. The evolution of the criteria of frailty, cognitive state, eating pattern, emotional state, quality of sleep, perceived social support, quality of life, functional capacity in daily life, adverse results, assessment of self-efficacy and cost-utility analysis variables will be evaluated. Possible confounding factors such as sociodemographic variables, comorbidity and polymedication will be controlled. Intention-to-treat analysis will be performed.
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
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients over 65 years of age who present frailty or pre-frailty, assessed using the Fried criteria adapted to Spanish population;
- •Patients belonging to Clinical Management Units participating in the study and who will remain in it for the 15 months of the study;
- •Patients who can come to the Health Center alone or accompanied.
排除标准
- •Patients with no full control of their capabilities.
- •Patients who do not understand Spanish;
- •Patients with allergies to plastic or metal.
- •Patients who are instutionalized.
结局指标
主要结局
Evaluation of the Change of Baseline Fried Frailty Criteria at 6 Months
时间窗: Preintervention/Postintervention (0 and 6 months)
Assessment of frailty using the Fried Frailty Phenotype. This is a five-component measure used to classify frailty status (unintentional weight loss, exhaustion, weakness, slow walking speed, and low physical activity). A score of 1 is assigned for each criterion met, yielding a total score that ranges from 0 to 5. A higher score indicates a worse outcome (greater frailty). 0 = Robust (non-frail) 1-2 = Pre-frail 3-5 = Frail
Evaluation of the Change of Baseline Fried Frailty Criteria at 12 Months
时间窗: Preintervention/Retest (0 and 12 months)
Assessment of frailty using the Fried Frailty Phenotype. This is a five-component measure used to classify frailty status (unintentional weight loss, exhaustion, weakness, slow walking speed, and low physical activity). A score of 1 is assigned for each criterion met, yielding a total score that ranges from 0 to 5. A higher score indicates a worse outcome (greater frailty). 0 = Robust (non-frail) 1-2 = Pre-frail 3-5 = Frail
次要结局
未报告次要终点