Effectiveness of an Intervention by a Health Education Workshop Compared With the Usual Advice to Reduce the Incidence of Falls in Independent 65 Years and Older Not Institutionalized. Primary Prevention.CHANGING TO NEVER FALL. CTNF
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 316
- 试验地点
- 1
- 主要终点
- % incidence of falls in a year
研究概览
简要总结
The purpose of this study is to determine whether a primary prevention workshop is effective decreasing at least 13% the annual incidence of falls in elderly compared to the habitual counseling.
Before the first fall incident, the elderly aged 65 or more, living in community, are invited to attend a workshop on fall preventing activities and factor risk detection. This activity consists on four sessions (one session per week during three weeks and the fourth session one year later) in which the elderly are expected to detect their own fall risk factors, encouraged to introduce healthy habits and to increase physical activity in order to improve strength and balance specifically.
This workshop has been prepared by family physicians following the latest scientific recommendations, it will be lead by them on the first edition, but it has not been written in formal language in order to be used by volunteers concerned about aging topics, independent from the Health Service.
详细描述
This study is a Clinical Trial. The methodology is to compare the incidence of falls in two groups. The intervention group will attend a three session workshop, will learn to recognize their risk factors for fall, will be encouraged to adopt a healthy diet (vitamin D consumption), modify home hazards , and increase physical activity (a strength and balance program at home and a group walking route). After a monthly telephone follow-up they are invited to attend a recall session, were they realize the change in the strength and balance tests results.
The control group will attend a single workshop session summarizing the major points of prevention of falls ( risk factors of fall, healthy diet and vitamin D consumption, home hazards, physical activity). After a monthly telephone follow-up they are invited to attend the three session workshop for further prevention.
GOALS
GENERAL Evaluate the effectiveness of an intervention program in the form of health education workshop to reduce the incidence of falls in independent population aged 65 and older living in the community.
SPECIFIC:
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, Outcomes Assessor)
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
- •person 65 years or older
- •habitual residence (more than nine months per year) in the coverage area of the senior center participants,
- •walk independently without help from another person,
- •able to attend all sessions,
- •acceptance telephone follow-up,
- •commitment to attend the final session,
- •and given their informed consent to participate in the trial.
排除标准
- •institutionalized person,
- •moderate or severe cognitive impairment of any etiology,
- •blindness,
- •total deafness,
- •trouble reading,
- •absolute contraindication for exercise or surgery in the previous 6 months,
- •engaged in other activities such muscle strengthening or tai chi balance.
结局指标
主要结局
% incidence of falls in a year
时间窗: one year
% of incidence of falls in a year
次要结局
- score in Mediterranean diet adherence test SEEDO (Sociedad Española para el Estudio de la Obesidad)(one year)
- number of home hazards modification(one year)
- Score EuroQol-5D (EQ-5D)(one year)
- score in Short Physical Performance Battery (SPPB o Test de Guralnik)(one year)
- dietary vitamin D intake(one year)
- % body mass index BMI(one year)
- score FES-I test (Fall Efficacy Scale)(one year)
- Score short MNA_spanish (Mini Nutritional Assessment)(one year)
研究者
MARIA MEDINA SAMPEDRO
Especialista en Medicina Familiar y Comunitaria, Máster en Investigación en Atención Primaria, Coordinadora del Grupo de trabajo de Atención al Mayor de Somamfyc
Sociedad Madrileña de Medicina de Familia y Comunitaria