Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 9:47 PM
Study NCT ID:
NCT07447492
Status:
COMPLETED
Last Update Posted:
2026-03-03
First Post:
2026-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Design and Testing of a Person-centered Telecare Model for Healthy Aging in Bogotá
Sponsor:
Hospital Universitario San Ignacio
Organization:
Study Overview
Official Title:
Design and Testing of a Person-centered Telecare Model Focused on Social Support and Case Management for Healthy Aging Among Older Adults in Bogotá
Status:
COMPLETED
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
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.
Case Management and Resource Linkage: Identification and mobilization of social and health resources within participants' homes, neighborhoods, and city to create a robust support portfolio.
Implementation Phases
Phase 1 (Months 1-4): Characterization of participants through a baseline home visit (Visit 0) using CGA and ICOPE screening. Participatory design and production of the telecare device prototype.
Phase 2 (Implementation): Deployment of the telecare model, including training for "gestores" (care managers) and participants.
Phase 3 (Follow-up): Continuous monitoring with formal evaluations every 6 months over a 24-month period.
Assessment and Outcomes
The study evaluates the model's impact on:
Primary Outcome: Change in physical capacity measured by the Short Physical Performance Battery (SPPB).
Secondary Outcomes: Mortality, frequency of emergency room visits, hospitalizations, institutionalization rates, and changes in quality of life (Euro-QoL), cognitive function (MMSE/MOCA), and depressive symptoms (Yesavage).
Statistical Considerations The trial aims for a total sample of 152 participants (76 per arm), accounting for a 20% estimated loss to follow-up, to achieve 90% statistical power. Participants are randomly assigned to either the intervention group or the "usual care" control group using a computerized system.
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.
Case Management and Resource Linkage: Identification and mobilization of social and health resources within participants' homes, neighborhoods, and city to create a robust support portfolio.
Implementation Phases
Phase 1 (Months 1-4): Characterization of participants through a baseline home visit (Visit 0) using CGA and ICOPE screening. Participatory design and production of the telecare device prototype.
Phase 2 (Implementation): Deployment of the telecare model, including training for "gestores" (care managers) and participants.
Phase 3 (Follow-up): Continuous monitoring with formal evaluations every 6 months over a 24-month period.
Assessment and Outcomes
The study evaluates the model's impact on:
Primary Outcome: Change in physical capacity measured by the Short Physical Performance Battery (SPPB).
Secondary Outcomes: Mortality, frequency of emergency room visits, hospitalizations, institutionalization rates, and changes in quality of life (Euro-QoL), cognitive function (MMSE/MOCA), and depressive symptoms (Yesavage).
Statistical Considerations The trial aims for a total sample of 152 participants (76 per arm), accounting for a 20% estimated loss to follow-up, to achieve 90% statistical power. Participants are randomly assigned to either the intervention group or the "usual care" control group using a computerized system.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2020/178 | OTHER | Acta 17/2020 | View |