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.
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.
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.
Parallel
health intervention with a socio-community approach
BehavioralThe 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.
Score on the FRAIL Scale
Frailty will be assessed using the FRAIL Scale, which evaluates five domains: fatigue, resistance, ambulation, illnesses, and weight loss. The total score ranges from 0 to 9, where higher scores indicate greater frailty
Barthel Index
Measures independence in basic activities of daily living. The score ranges from 0 to 100, where higher scores indicate greater independence.
Lawton Score
Assesses instrumental activities of daily living (IADLs), with a score range of 0 to 8. Higher scores indicate better ability to perform IADLs independently.
Downton Scale
Evaluates the risk of falls in older adults, considering factors such as previous falls, medication use, sensory deficits, mental status, and walking ability. The score ranges from 0 to 14, where higher scores indicate a higher risk of falls.
Score on the Montreal Cognitive Assessment (MoCA)
The MoCA is a global cognitive screening tool that assesses memory, attention, language, abstraction, executive function, calculation, and orientation. Scores range from 0 to 30, with higher scores indicating better cognitive function
Adverse Events
Adverse events refer to any undesirable experiences or occurrences resulting from the intervention, including but not limited to side effects, complications, or unexpected outcomes. All adverse events will be recorded and categorized based on their severity (e.g., mild, moderate, severe) and their relationship to the intervention (e.g., related, possibly related, unrelated)
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Keralty SAS. Colombia
Lead sponsor
Inter-American Development Bank
Collaborator
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