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

NCT06663150 | Not Yet Recruiting

• 1 other identifier: 092-24 UNV
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Prefrailty; Frailty; Older Adults

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline, 3, 6 Months

Secondary Outcomes (13)

• Barthel Index

  Baseline, 3, 6 Months

• Lawton Score

  Baseline, 3, 6 Months

• Downton Scale

  Baseline, 3, 6 Months

• Score on the Montreal Cognitive Assessment (MoCA)

  Baseline, 3, 6 Months

• Score on the Yesavage Geriatric Depression Scale (GDS)

  Baseline, 3, 6 Months

Other Outcomes (1)

• Adverse Events

  During the 6-month intervention.

Study Arms (2)

Experimental group

EXPERIMENTAL

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.

Behavioral: health intervention with a socio-community approach

Control group

NO INTERVENTION

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

Interventions

health intervention with a socio-community approach BEHAVIORAL

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.

Experimental group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Keralty SAS. Colombia: lead
• Inter-American Development Bank: collaborator

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lina Sofía Morón-Duarte, PhD

  keralty

  STUDY CHAIR

Central Study Contacts

Nancy Yomayusa Gonzalez, Dr

CONTACT

+57 601 4871920; igek@keralty.com

Kelly Rocio Chacón-Acevedo, Msc

CONTACT

krchacon@keralty.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 29, 2024
• Study Start: November 15, 2024
• Primary Completion: November 30, 2025
• Study Completion (Estimated): November 30, 2026
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share