Efectividad de la intervención AMICOPE Para Mejorar y/o Mantener la Salud Autopercibida y la Capacidad intrínseca en Personas Mayores: un Ensayo clínico Aleatorizado (EFICIS)
试验速览
- 阶段
- 不适用
- 入组人数
- 212
- 主要终点
- Self-perceived health
研究概览
简要总结
In their day to day, persons do from simple to more or less complicated tasks and activities (ie: stand from a chair, open a door, shopping, read, drive, play chess, remind an appointment...). Such ability to do things is called capacity. Intrinsic capacity is the combination of all the physical and mental capacities that a person has, and reach its maximum in the early adulthood and then declines as the person ages. Each kind of capacity declines at her own speed (which may be faster or slower according to each person lifestyle), and once drops below a threshold may lead to a reduction in quality of life and loss of autonomy.
Nevertheless there are some actions that may be effective to prevent or slow such decline. To do so the investigators have design an intervention that combines several things of different nature (what is know as a complex intervention) called AMICOPE. The AMICOPE intervention is performed in the community or in primary care centers through 12 weekly group sessions of 2 h 30 min which combine structured and adapted physical activity, group dynamics to promote social support and address loneliness, social isolation and depressive symptoms, and dietary advice.
Our study is addressed to persons over 70 with light problems in mobility, nutrition or mood state.
The purpose of this study is to assess if the AMICOPE intervention is better than the standard advice to follow healthy lifestyles to improve or maintain self-perceived health, mobility, nutritional status an psychological wellbeing.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To live in the community
- •To be able to move autonomously to the intervention place
- •To Have a deficit in at least one mobility, vitality or psychological domains in the Integrated Care for Older People (ICOPE) screening tool confirmed by a reference test, namely:
- •A - Mobility: unable to stand up from a chair 5 times in less than 14 seconds AND having less than 10 points in the Short Physical Performance Battery (SPPB).
- •B - Vitality: any nutritional problem from the ICOPE screening tool (loss of appetite OR losing more than 3 Kg not intentionally in the last 3 months) AND having less than 12 points in MNA (malnutrition or malnutrition risc).
- •C - Psychological: any depressive symptoms from the ICOPE screening tool (answer that in the last two weeks has had feelings of sadness, melancholy OR hopelessness or refer lack of interest or pleasure when doing things) AND the presence of at least two or more symptoms on the 5-item Geriatric Depression Scale (GDS5).
排除标准
- •People with previous diagnosis of dementia or cognitive decline with a score below 24 points in the Minimental State Examination (MMSE).
- •People in the end of life.
- •People who have factors that prevent or contraindicate the performance of the planned interventions, such as contraindication to physical activity, mental or (non-corrected) communication issues that makes it difficult to participate in group dynamics.
研究组 & 干预措施
1. Intervention group
AMICOPE multicomponent intervention:
- Physical activity (VIVIFRAIL program): 10 hours.
- Nutrition: 6,5 hours.
- Psychology: 6,5 hours.
- Personal autonomy: 4,5 hours
- Learn about community resources: 2, 5 hours
干预措施: VIVIFRAIL (Other)
1. Intervention group
AMICOPE multicomponent intervention:
- Physical activity (VIVIFRAIL program): 10 hours.
- Nutrition: 6,5 hours.
- Psychology: 6,5 hours.
- Personal autonomy: 4,5 hours
- Learn about community resources: 2, 5 hours
干预措施: Nutrition (Other)
1. Intervention group
AMICOPE multicomponent intervention:
- Physical activity (VIVIFRAIL program): 10 hours.
- Nutrition: 6,5 hours.
- Psychology: 6,5 hours.
- Personal autonomy: 4,5 hours
- Learn about community resources: 2, 5 hours
干预措施: Psychology (Behavioral)
1. Intervention group
AMICOPE multicomponent intervention:
- Physical activity (VIVIFRAIL program): 10 hours.
- Nutrition: 6,5 hours.
- Psychology: 6,5 hours.
- Personal autonomy: 4,5 hours
- Learn about community resources: 2, 5 hours
干预措施: Personal autonomy (Behavioral)
1. Intervention group
AMICOPE multicomponent intervention:
- Physical activity (VIVIFRAIL program): 10 hours.
- Nutrition: 6,5 hours.
- Psychology: 6,5 hours.
- Personal autonomy: 4,5 hours
- Learn about community resources: 2, 5 hours
干预措施: Community resources (Other)
2. Control group
Control group participants will receive usual advice on healthy lifestyle habits and a follow-up phone call from healthcare professionals.
干预措施: Standard recommendations (Other)
结局指标
主要结局
Self-perceived health
时间窗: Baseline, after the intervention (average 16 weeks)
Change in self-perceived health status according to the Euroqol Visual Analogue Scale, where participants scores from 0 (worse state) to 100 (better state) their current perceived health
次要结局
- Depressive symptoms(Baseline, after the intervention (average 16 weeks))
- Autonomy in daily life.(Baseline, after the intervention (average 16 weeks))
- Health related quality of life.(Baseline, after the intervention (average 16 weeks))
- Physical activity.(Baseline, after the intervention (average 16 weeks))
- Functional status(Baseline, after the intervention (average 16 weeks))
- Nutritional status(Baseline, after the intervention (average 16 weeks))
- Social support and risk of isolation(Baseline, after the intervention (average 16 weeks))
- Loneliness(Baseline, after the intervention (average 16 weeks))