Design and Testing of a Person-centered Telecare Model Focused on Social Support and Case Management for Healthy Aging Among Older Adults in Bogotá
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 155
- 试验地点
- 1
- 主要终点
- Short Physical Performance Battery (SPPB).
研究概览
简要总结
What is the purpose of this study? The main goal of this study is to design and test a new "telecare" model to help adults aged 80 and older in Bogotá live healthier and more independent lives. The investigators want to see if providing personalized support through technology can improve physical health, prevent falls, and reduce the need for hospital visits or nursing home care.
Why is this study important? As people get older, they may face more health challenges or feel lonely, especially if they live alone. Traditional healthcare often focuses only on treating illnesses. This study focuses on "healthy aging" by looking at the whole person-including physical health, social support, and daily needs-to help participants stay active and safe in their own homes.
Who can participate?
Participants in this study are adults who:
Are 80 years of age or older.
Live in the urban area of Bogotá.
Are affiliated with Compensar EPS.
Are generally independent (able to perform most daily activities).
Can be reached by telephone.
What will happen during the study? Participants will be randomly assigned to one of two groups: a group receiving the new telecare support or a "usual care" group.
Assessment: At the start, the research team will visit participants' homes to understand participants' health, home environment, and needs.
The Telecare Model: Those in the intervention group will use a simple, easy-to-use device designed specifically for older adults. Through this device, participants will receive:
Health tips and training on self-care.
Support from "case managers" who help coordinate social and health services.
Connections to a support network of family, neighbors, and community resources.
Follow-up: Every six months, the team will check in to see how participants are doing and measure changes in physical and mental well-being.
What are the expected benefits? The investigators hope this model will help participants maintain physical strength and memory, feel more connected to the community, and enjoy a better quality of life. The results will help improve how Bogotá cares for its older citizens in the future.
详细描述
Study Design and Framework This study is a mixed-methods research project (quantitative and qualitative) centered on a randomized clinical trial to evaluate a person-centered sociosanitary telecare model. The model is based on the World Health Organization Integrated Care for Older People (ICOPE) strategy and the Comprehensive Geriatric Assessment (CGA). It focuses on maintaining functional capacity and intrinsic capacity through five domains: locomotion, vitality (nutrition), sensory capacity, cognition, and psychological well-being.
Intervention Plan
The intervention group will receive a multifaceted telecare program integrated through a simplified technological device specifically designed for older adults. The intervention consists of three core components:
Healthy Aging Interventions: Tailored health activities based on the ICOPE guidelines.
Training: Education for participants on self-care and for participants' social support network (family, caregivers, and community "case managers") on supporting functional maintenance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Due to the nature of the intervention (telecare and case management), it is not possible to mask the participants or the personnel delivering the intervention. However, to minimize bias, the following parties will be masked:
Outcomes Assessors: The individuals responsible for performing the follow-up geriatric assessments and measuring primary/secondary outcomes (such as the SPPB and cognitive tests) will be blinded to the participants' group assignment.
Data Analysts/Statisticians: The research team performing the statistical analysis will work with de-identified data and will be blinded to the group allocation until the primary analysis is completed.
Principal Investigators: While involved in oversight, the PIs will remain blinded to individual participant allocations during the data collection phase to the extent possible
入排标准
- 年龄范围
- 80 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Eligibility Criteria
- •Inclusion Criteria:
- •Adults aged 80 years or older.
- •Residents of the urban area of Bogotá, Colombia.
- •Affiliated with the health insurance provider (EPS) Compensar.
- •Functionally independent or with mild dependence (defined by the ability to perform basic activities of daily living).
- •Ability to communicate via telephone (landline or mobile).
- •Signed informed consent to participate in the study.
排除标准
- •Severe cognitive impairment that prevents following instructions or using the telecare device (e.g., advanced dementia).
- •Severe sensory impairments (total blindness or profound deafness) that preclude the use of the technology provided.
- •Participants currently enrolled in another clinical trial or intensive home-care program that overlaps with the study intervention.
- •End-of-life condition or terminal illness with a life expectancy of less than 6 months.
- •Total functional dependence (bedbound or requiring permanent assistance for all daily activities).
研究组 & 干预措施
Experimental: Person-Centered Telecare Model
Participants will receive a sociosanitary telecare intervention including a dedicated technological device, case management, and health interventions based on the WHO ICOPE framework to maintain functional capacity
干预措施: Telecare and Case Management Program (Behavioral)
usual care
participants will receive the standard healthcare services provided by their health insurance provider (Compensar EPS) in Bogotá. They will not receive the telecare device or the specialized case management.
干预措施: Usual Care (Other)
结局指标
主要结局
Short Physical Performance Battery (SPPB).
时间窗: Baseline (Month 0) and every 6 months for a total duration of 24 months.
The study evaluates the effectiveness of the telecare intervention by measuring changes in the participants' physical performance. The SPPB is a standardized tool that assesses balance, gait speed, and lower limb strength (chair stand test). A significant functional decline is defined as a change of more than one point in the total SPPB score. The score ranges from 0 to 12, where lower scores indicate poorer physical performance and a higher risk of disability
次要结局
未报告次要终点