- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07447492
Design and Testing of a Person-centered Telecare Model for Healthy Aging in Bogotá
Design and Testing of a Person-centered Telecare Model Focused on Social Support and Case Management for Healthy Aging Among Older Adults in Bogotá
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bogotá, Colombia
- Hospital Universitario San Ignacio
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
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.
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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
|
Multifaceted intervention involving a telecare device for monitoring, personalized health care paths (ICOPE), and social support network management.
|
|
Other: 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.
|
Standard health promotion and prevention programs provided by the EPS.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Short Physical Performance Battery (SPPB).
Time Frame: 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
|
Baseline (Month 0) and every 6 months for a total duration of 24 months.
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Guralnik JM, et al. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994. PMID: 8126352
- World Health Organization (WHO) ICOPE Framework: * Citation: World Health Organization. (2019). Integrated care for older people (ICOPE): guidance for person-centred assessment and pathways in primary care. PMID: 31251544
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020/178 (Other Identifier: Acta 17/2020)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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