Comparación Entre Ingreso Hospitalario y Hospitalización Domiciliaria y Análisis de Una Intervención Multicomponente en Adultos Mayores: Ensayo Clínico Aleatorizado
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Physical function
研究概览
简要总结
This research project is structured in two phases: an initial observational phase and a subsequent randomized controlled trial (RCT) phase. The goal of the observational phase is to compare hospital admission and Hospital at Home (HaH). The objective of the RCT is to assess the effectiveness of a multicomponent intervention following acute hospitalization in older adults. The main questions it aims to answer are:
- What are the differences between hospital admission and HaH in sedentary and physical activity levels?
- What are the effects of a multicomponent intervention following acute hospitalization in older adults?
Researchers will compare a post-discharge multicomponent intervention to usual care to see the effects on physical and cognitive function.
Participants will receive a home-based cognitive and physical exercise intervention or usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Older adults admitted to the hospital or Hospital at Home (HaH) due to an acute illness.
- •Residents of Navarre.
- •Willingness to participate on a voluntary basis.
- •Ability to ambulate with or without assistance.
- •Ability to communicate and collaborate with the research staff.
排除标准
- •Acute illness that does not allow the assessment and practice of physical exercise during the study.
- •Medical contraindication for the practice of physical exercise.
- •Severe dementia.
- •Refusal to sign the informed consent form by the patient, accompanying person, or legal guardian.
结局指标
主要结局
Physical function
时间窗: Within the first 24-48 hours of acute care admission (in hospital or home hospitalization), pre-intervention baseline, and immediately after the intervention.
Short Physical Performance Battery (SPPB): scores range from 0 to 12, with higher scores indicating better physicalfunction.
Cognitive function
时间窗: Within the first 24-48 hours of acute care admission (in hospital or home hospitalization), pre-intervention baseline, and immediately after the intervention.
Mini-Mental State Examination (MMSE): scores range from 0 to 30, with higher scores indicating better cognitive function.
Physical activity
时间窗: During hospital stay or during home-base hospitalization .
Physical activity will be assessed with a Firstbeat device (format: hh:mm:ss).
Sedentarism
时间窗: During hospital stay or during home-based hospitalization.
Sedentarism will be assessed with a Firstbeat device (format: hh:mm:ss).
次要结局
- Cost-effectiveness(At pre-intervention baseline, at 3 months post-discharge, at 6 months post-discharge, and at 12 months post-discharge.)
- Health-related quality of life (HRQOL)(Pre-intervention baseline and immediately after the intervention.)
- Heart rate variability(During hospital stay or during home-based hospitalization.)
- Handgrip strength(Within the first 24-48 hours of acute care admission (in hospital or home hospitalization), pre-intervention baseline, and immediately after the intervention.)
- Sleep quantity(During hospital stay or during home-based hospitalization.)
- Sleep quality(During hospital stay or during home-based hospitalization.)
- Energy expenditure(Within the first 24-48 hours of acute care admission (in hospital or home hospitalization), pre-intervention baseline, and immediately after the intervention.)
- Rate of hospital readmissions(3 months, 6 months, and 12 months post-discharge.)
- Rate of falls(3 months, 6 months, and 12 months post-discharge.)
- Incidence of mortality(3 months, 6 months, and 12 months post-discharge.)
- Rate of emergency visits(3 moths, 6 months, and 12 months post-discharge.)
- Prescribed pharmacologic treatment(Within the first 24-48 hours of acute care admission (in hospital or home hospitalization), pre-intervention baseline, and immediately after the intervention.)