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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017216', 'term': 'Telemedicine'}], 'ancestors': [{'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': "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:\n\nOutcomes 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.\n\nData 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.\n\nPrincipal Investigators: While involved in oversight, the PIs will remain blinded to individual participant allocations during the data collection phase to the extent possible"}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': "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:\n\nOutcomes 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.\n\nData 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.\n\nPrincipal Investigators: While involved in oversight, the PIs will remain blinded to individual participant allocations during the data collection phase to the extent possible"}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 155}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-26', 'studyFirstSubmitDate': '2026-02-11', 'studyFirstSubmitQcDate': '2026-02-26', 'lastUpdatePostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Short Physical Performance Battery (SPPB).', 'timeFrame': 'Baseline (Month 0) and every 6 months for a total duration of 24 months.', 'description': "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"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Telecare', 'Case Management', 'Remote Monitoring', 'M-Health', 'Social Support Network'], 'conditions': ['Healthy Ageing']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': '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'}, {'type': 'BACKGROUND', 'citation': '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'}], 'seeAlsoLinks': [{'url': 'https://www.who.int/teams/maternal-newborn-child-adolescent-health-and-ageing/ageing-and-health/integrated-care-for-older-people-icope', 'label': 'Integrated care for older people approach (ICOPE)'}]}, 'descriptionModule': {'briefSummary': '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.\n\nWhy 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.\n\nWho can participate?\n\nParticipants in this study are adults who:\n\nAre 80 years of age or older.\n\nLive in the urban area of Bogotá.\n\nAre affiliated with Compensar EPS.\n\nAre generally independent (able to perform most daily activities).\n\nCan be reached by telephone.\n\nWhat 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.\n\nAssessment: At the start, the research team will visit participants\' homes to understand participants\' health, home environment, and needs.\n\nThe 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:\n\nHealth tips and training on self-care.\n\nSupport from "case managers" who help coordinate social and health services.\n\nConnections to a support network of family, neighbors, and community resources.\n\nFollow-up: Every six months, the team will check in to see how participants are doing and measure changes in physical and mental well-being.\n\nWhat 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.', 'detailedDescription': '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.\n\nIntervention Plan\n\nThe 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:\n\nHealthy Aging Interventions: Tailored health activities based on the ICOPE guidelines.\n\nTraining: Education for participants on self-care and for participants\' social support network (family, caregivers, and community "case managers") on supporting functional maintenance.\n\nCase Management and Resource Linkage: Identification and mobilization of social and health resources within participants\' homes, neighborhoods, and city to create a robust support portfolio.\n\nImplementation Phases\n\nPhase 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.\n\nPhase 2 (Implementation): Deployment of the telecare model, including training for "gestores" (care managers) and participants.\n\nPhase 3 (Follow-up): Continuous monitoring with formal evaluations every 6 months over a 24-month period.\n\nAssessment and Outcomes\n\nThe study evaluates the model\'s impact on:\n\nPrimary Outcome: Change in physical capacity measured by the Short Physical Performance Battery (SPPB).\n\nSecondary 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).\n\nStatistical 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '80 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Eligibility Criteria\n\nInclusion Criteria:\n\n* Adults aged 80 years or older.\n* Residents of the urban area of Bogotá, Colombia.\n* Affiliated with the health insurance provider (EPS) Compensar.\n* Functionally independent or with mild dependence (defined by the ability to perform basic activities of daily living).\n* Ability to communicate via telephone (landline or mobile).\n* Signed informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Severe cognitive impairment that prevents following instructions or using the telecare device (e.g., advanced dementia).\n* Severe sensory impairments (total blindness or profound deafness) that preclude the use of the technology provided.\n* Participants currently enrolled in another clinical trial or intensive home-care program that overlaps with the study intervention.\n* End-of-life condition or terminal illness with a life expectancy of less than 6 months.\n* Total functional dependence (bedbound or requiring permanent assistance for all daily activities).'}, 'identificationModule': {'nctId': 'NCT07447492', 'briefTitle': 'Design and Testing of a Person-centered Telecare Model for Healthy Aging in Bogotá', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario San Ignacio'}, 'officialTitle': 'Design and Testing of a Person-centered Telecare Model Focused on Social Support and Case Management for Healthy Aging Among Older Adults in Bogotá', 'orgStudyIdInfo': {'id': '2020/178'}, 'secondaryIdInfos': [{'id': '2020/178', 'type': 'OTHER', 'domain': 'Acta 17/2020'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Person-Centered Telecare Model', 'description': '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', 'interventionNames': ['Behavioral: Telecare and Case Management Program']}, {'type': 'OTHER', 'label': 'usual care', 'description': '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.', 'interventionNames': ['Other: Usual Care']}], 'interventions': [{'name': 'Telecare and Case Management Program', 'type': 'BEHAVIORAL', 'description': 'Multifaceted intervention involving a telecare device for monitoring, personalized health care paths (ICOPE), and social support network management.', 'armGroupLabels': ['Experimental: Person-Centered Telecare Model']}, {'name': 'Usual Care', 'type': 'OTHER', 'description': 'Standard health promotion and prevention programs provided by the EPS.', 'armGroupLabels': ['usual care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bogotá', 'country': 'Colombia', 'facility': 'Hospital Universitario San ignacio', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': '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'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario San Ignacio', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}