Effectiveness of a Health Intervention With a Socio-community Approach on Frailty in Older Adults With Pre-frailty
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 主要终点
- Score on the FRAIL Scale
研究概览
简要总结
The objective of this study is: To evaluate the effectiveness of a health intervention with a socio-community approach on frailty in older adults with pre-frailty.
Specific Objectives:
To characterize the study population according to sociodemographic and clinical variables.
To evaluate the effect of the intervention on the functionality domain at 3 and 6 months.
To evaluate the effect of the intervention on the cognitive-emotional domain at 3 and 6 months.
To evaluate the effect of the intervention on the socio-community domain at 3 and 6 months.
To evaluate the effect of the intervention on frailty in older adults. To determine the proportion of participants hospitalized during the study period.
To determine the proportion of participants who visited the emergency room during the study period.
To determine the proportion of participants in long-term care facilities. To determine the proportion of adverse events associated with the intervention.
Study Hypothesis
The mean frailty score pre-intervention is equal to the mean frailty score post-intervention.
The mean frailty score pre-intervention is different from the mean frailty score post-intervention.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals ≥ 60 years old classified as pre-frail in the last 3 months and documented in their medical history.
- •Individuals who meet the requirements and provide voluntary informed consent for their participation.
- •Individuals available to remain in Bogotá D.C. during the study period.
排除标准
- •Individuals receiving care at community-focused medical centers.
- •Individuals attending community dining programs, physical activity programs, community groups, care blocks, volunteering, or other related activities.
- •Individuals who have experienced falls in the last 6 months with clinical consequences (hospitalization, fractures, traumatic brain injury).
- •Individuals with a clinical history of moderate cognitive impairment, neurodegenerative diseases (e.g., Parkinson's disease), and/or neuro-musculoskeletal disorders, active cancer, end-stage renal disease, unstable ischemic heart disease, uncontrolled arrhythmias, severe aortic stenosis, uncontrolled hypertension (>180/100 mmHg), or advanced heart failure, exacerbation of chronic diseases (COPD, heart failure), unrehabilitated severe hearing loss, deafness, or blindness with communication limitations.
- •Acute conditions requiring hospitalization, such as acute myocardial infarction or urinary tract infections.
- •Bone fractures in the last 3 months.
- •Individuals unable to follow instructions or with behavioral changes that hinder their participation in the study.
- •Individuals with severe psychiatric illness that, in the physician's judgment, prevents proper adherence to the study intervention.
- •Institutionalized individuals in long-term care facilities.
结局指标
主要结局
Score on the FRAIL Scale
时间窗: Baseline, 3, 6 Months
Frailty will be assessed using the FRAIL Scale, which evaluates five domains: fatigue, resistance, ambulation, illnesses, and weight loss. The total score ranges from 0 to 9, where higher scores indicate greater frailty
次要结局
- Barthel Index(Baseline, 3, 6 Months)
- Lawton Score(Baseline, 3, 6 Months)
- Downton Scale(Baseline, 3, 6 Months)
- Score on the Montreal Cognitive Assessment (MoCA)(Baseline, 3, 6 Months)
- Score on the Yesavage Geriatric Depression Scale (GDS)(Baseline, 3, 6 Months)
- Score on the Gijón Family-Social Assessment Scale(Baseline, 3, 6 Months)
- Score on the Lubben Social Network Scale(Baseline, 3, 6 Months)
- Health-Related Quality of Life Measured by EQ-5D-3L(Baseline, 3, 6 Months)
- Number of Hospital Admissions(During the 6-month intervention)
- Total Number of Hospitalization Days(During the 6-month intervention)
- Total Number of Emergency Room Admissions(During the 6-month intervention.)
- Requirement for Admission to Long-Term Care Facilities(During the 6-month intervention.)
- Utilization of Social Health Assets(During the 6-month intervention.)