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

Keralty SAS. Colombia

Status: Not yet enrolling

Conditions: Frail Elderly Syndrome

Treatments: Behavioral: health intervention with a socio-community approach

Study type: Interventional

Funder types: Other

Identifiers

NCT06663150

092-24 UNV

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• Acute conditions requiring hospitalization, such as acute myocardial infarction or urinary tract infections.
• Bone fractures in the last 3 months.
• Individuals unable to follow instructions or with behavioral changes that hinder their participation in the study.
• Individuals with severe psychiatric illness that, in the physician's judgment, prevents proper adherence to the study intervention.
• Institutionalized individuals in long-term care facilities.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Experimental group

Experimental group

Description:

Education Component: Lectures and workshops aimed at enhancing awareness and personal growth through knowledge and emotional reflection. Cognitive Component: One-hour sessions divided into introduction (15 min), cognitive stimulation activities (35 min), and closure with reflection and a brief survey. Physical Activity Component: A 10-minute warm-up, followed by 30 minutes of guided exercises for balance, coordination, and strength, ending with a 10-minute cool-down. Nutrition Component: Practical workshops focused on healthy eating, including menu planning and food preparation. Socio-Community and Occupational Component: Encourages community integration and social networking, with gardening activities for growing herbs and vegetables. Autonomous Activities: Participants implement physical activity recommendations in daily life, with weekly follow-ups by the research team using the RedCap platform for monitoring.

Treatment:

Behavioral: health intervention with a socio-community approach

Control group

No Intervention group

Description:

The control group will maintain the usual care provided by their healthcare service provider.