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Effectiveness of a Socio-Community Health Intervention on Pre-Frailty in Older Adults

NCT06663150 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2024-10-29

No results posted yet for this study

Summary

The objective of this study is: To evaluate the effectiveness of a health intervention with a socio-community approach on frailty in older adults with pre-frailty.

Specific Objectives:

To characterize the study population according to sociodemographic and clinical variables.

To evaluate the effect of the intervention on the functionality domain at 3 and 6 months.

To evaluate the effect of the intervention on the cognitive-emotional domain at 3 and 6 months.

To evaluate the effect of the intervention on the socio-community domain at 3 and 6 months.

To evaluate the effect of the intervention on frailty in older adults. To determine the proportion of participants hospitalized during the study period.

To determine the proportion of participants who visited the emergency room during the study period.

To determine the proportion of participants in long-term care facilities. To determine the proportion of adverse events associated with the intervention.

Study Hypothesis

The mean frailty score pre-intervention is equal to the mean frailty score post-intervention.

The mean frailty score pre-intervention is different from the mean frailty score post-intervention.

Conditions

  • Frail Elderly Syndrome

Interventions

BEHAVIORAL

health intervention with a socio-community approach

The intervention consists of five components, including education, cognitive stimulation, physical activity, nutrition, and socio-community aspects. The duration of the intervention will be 6 months and will be conducted in either in-person or virtual format, individually or in groups, depending on the nature of each component. Mode of Delivery: The intervention will be offered in both in-person and synchronous virtual formats. Participants who are unable to attend in person or who face difficulties doing so on any occasion will have the option to join the sessions through a real-time videoconferencing platform. In both modalities, the professionals in charge will supervise and guide the activities, ensuring proper execution and adherence to the study's objectives. The research team will maintain a detailed record of attendance and participation using the RedCap platform for appropriate tracking.

Sponsors & Collaborators

  • Inter-American Development Bank

    collaborator OTHER

  • Keralty SAS. Colombia

    lead OTHER

Principal Investigators

  • Lina Sofía Morón-Duarte, PhD · keralty

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-15
Primary Completion
2025-11-30
Completion
2026-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06663150 on ClinicalTrials.gov