NCT07447492

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
155

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 3, 2026

Completed
Last Updated

March 3, 2026

Status Verified

February 1, 2026

Enrollment Period

4.2 years

First QC Date

February 11, 2026

Last Update Submit

February 26, 2026

Conditions

Keywords

TelecareCase ManagementRemote MonitoringM-HealthSocial Support Network

Outcome Measures

Primary Outcomes (1)

  • Short Physical Performance Battery (SPPB).

    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.

Study Arms (2)

Experimental: Person-Centered Telecare Model

EXPERIMENTAL

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

Behavioral: Telecare and Case Management Program

usual care

OTHER

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.

Other: Usual Care

Interventions

Multifaceted intervention involving a telecare device for monitoring, personalized health care paths (ICOPE), and social support network management.

Experimental: Person-Centered Telecare Model

Standard health promotion and prevention programs provided by the EPS.

usual care

Eligibility Criteria

Age80 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario San ignacio

Bogotá, Colombia

Location

Related Publications (2)

  • 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

    BACKGROUND
  • 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

    BACKGROUND

Related Links

MeSH Terms

Interventions

Telemedicine

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2026

First Posted

March 3, 2026

Study Start

December 1, 2020

Primary Completion

January 30, 2025

Study Completion

April 1, 2025

Last Updated

March 3, 2026

Record last verified: 2026-02

Locations