NCT06663150

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

Effectiveness of a Health Intervention With a Socio-community Approach on Frailty in Older Adults With Pre-frailty

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Keralty SAS. Colombia · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-11-15
• Primary completion: 2025-11-30
• Completion: 2026-11-30
• First posted: 2024-10-29
• Last updated: 2024-10-29