Healthy AgeingNCT07447492
Design and Testing of a Person-centered Telecare Model for Healthy Aging in Bogotá
A study testing Telecare and Case Management Program in people with Healthy Ageing, run by Hospital Universitario San Ignacio at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 80 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Ageing
- What is being tested?
- Telecare and Case Management Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteColombia
- Study dates
- 1 Dec 2020to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 80 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Healthy Ageing
- Being tested
- Telecare and Case Management Program, Usual Care
- Keywords
- Telecare, Case Management, Remote Monitoring, M-Health, Social Support Network
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telecare and Case Management ProgramBehavioural
Multifaceted intervention involving a telecare device for monitoring, personalized health care paths (ICOPE), and social support network management.
Usual CareOther
Standard health promotion and prevention programs provided by the EPS.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline (Month 0) and every 6 months for a total duration of 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start1 Dec 2020
- Primary completion30 Jan 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy AgeingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario San Ignacio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07447492
- Sponsor's protocol ID
- 2020/178
- Other IDs
- 2020/178
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data that underlie the results reported in articles published from this study, after de-identification (text, tables, figures, and appendices), will be shared with researchers who provide a methodologically sound proposal
Publications
Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. 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 Mar;49(2):M85-94. doi: 10.1093/geronj/49.2.m85.
PubMed 8126356World 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07447492
- Acronym / sponsor ID
- 2020/178
- Conditions
- Healthy Ageing
- Keywords
- Telecare, Case Management, Remote Monitoring, M-Health, Social Support Network
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Hospital Universitario San IgnacioUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Experimental: Person-Centered Telecare Model | Experimental | Behavioral: Telecare and Case Management ProgramParticipants 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 |
| usual care | Other | Other: Usual Careparticipants 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. |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telecare and Case Management ProgramMultifaceted intervention involving a telecare device for monitoring, personalized health care paths (ICOPE), and social support network management. | Behavioural | Experimental: Person-Centered Telecare Model |
| Usual CareStandard health promotion and prevention programs provided by the EPS. | Other | usual care |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Background: PubMed 8126356Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. 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 Mar;49(2):M85-94. doi: 10.1093/geronj/49.2.m85.
- BackgroundWorld 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
- Integrated care for older people approach (ICOPE)Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data that underlie the results reported in articles published from this study, after de-identification (text, tables, figures, and appendices), will be shared with researchers who provide a methodologically sound proposal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telecare and Case Management Program in people with Healthy Ageing, run by Hospital Universitario San Ignacio at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Physical Performance Battery (SPPB). (time frame: Baseline (Month 0) and every 6 months for a total duration of 24 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07447492, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.