A Randomised Controlled Trial on Falls and Malnutrition Prevention in the Community in 85 Year Old Subjects
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 328
- 试验地点
- 2
- 主要终点
- Rate of falls and rate of undernutrition risk as MNA < 23,5
研究概览
简要总结
Objective: To determine the effectiveness of an individual multifactorial intervention on falls and undernutrition risk in very older people in the community.
详细描述
Design: Randomized, controlled trial.
Method: Three hundred and twenty eight people born in 1924, after recruitment will be followed for a three year period. Subjects received two in-home visits from a trained nurse or physicians who assessed falls and nutritional risk factors using an algorithm.
The intervention consisted of recommendations to the subject and their primary physician, and other providers, telephone calls, and exercise and nutritional plan. Control subjects received a general primary care assessment.
Measurements: the primary outcome were rate of falls and rate of undernourished risk. Secondary outcomes included different geriatrics characteristics.The outcomes of this study will provide important new information to reduce the incidence of falls and the risk of undernutrition of this population by intervention. Significant differences are not expected according to social-demographics sex and other factors, but they are expected by other obtained factors and indices that could allow to detection of octogenarian people with great risk of deterioration in just a short time.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 85 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects born in 1924 of one of the 7 participating health centers and noninstitutionalized
排除标准
- •Institutionalized
结局指标
主要结局
Rate of falls and rate of undernutrition risk as MNA < 23,5
Nutritional risk was evaluated by the MNA questionnaire
次要结局
- Different geriatrics characteristics