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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorKeralty SAS. Colombia

About this trial

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.

Eligibility criteria

Qualifiers

Individuals ≥ 60 years old classified as pre-frail in the last 3 months and documented in their medical history.

Individuals who meet the requirements and provide voluntary informed consent for their participation.

Individuals available to remain in Bogotá D.C. during the study period.

Disqualifiers

Individuals receiving care at community-focused medical centers.

Individuals attending community dining programs, physical activity programs, community groups, care blocks, volunteering, or other related activities.

Individuals who have experienced falls in the last 6 months with clinical consequences (hospitalization, fractures, traumatic brain injury).

Individuals with a clinical history of moderate cognitive impairment, neurodegenerative diseases (e.g., Parkinson's disease), and/or neuro-musculoskeletal disorders, active cancer, end-stage renal disease, unstable ischemic heart disease, uncontrolled arrhythmias, severe aortic stenosis, uncontrolled hypertension (>180/100 mmHg), or advanced heart failure, exacerbation of chronic diseases (COPD, heart failure), unrehabilitated severe hearing loss, deafness, or blindness with communication limitations.

Trial design

Treatments tested in this trial

  • health intervention with a socio-community approach

Treatment groups

160 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Keralty SAS. Colombia

Lead sponsor

Inter-American Development Bank

Collaborator