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Completed

NCT Number: NCT06663150

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

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.

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Key information

Conditions

Frail Elderly Syndrome Frailty Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Colsanitas Medical Centers

Bogotá, Bogota D.C., Colombia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Score on the FRAIL Scale

    Time frame: Baseline, 3, 6 Months

    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

Secondary outcomes

  1. Barthel Index

    Time frame: Baseline, 3, 6 Months

    Measures independence in basic activities of daily living. The score ranges from 0 to 100, where higher scores indicate greater independence.

  2. Lawton Score

    Time frame: Baseline, 3, 6 Months

    Assesses instrumental activities of daily living (IADLs), with a score range of 0 to 8. Higher scores indicate better ability to perform IADLs independently.

  3. Downton Scale

    Time frame: Baseline, 3, 6 Months

    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.

  4. Score on the Montreal Cognitive Assessment (MoCA)

    Time frame: Baseline, 3, 6 Months

    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

  5. Score on the Yesavage Geriatric Depression Scale (GDS)

    Time frame: Baseline, 3, 6 Months

    The GDS is a tool used to assess depression in older adults, with scores ranging from 0 to 15. Higher scores indicate more severe depression.

  6. Score on the Gijón Family-Social Assessment Scale

    Time frame: Baseline, 3, 6 Months

    The Gijón Family-Social Assessment Scale evaluates the socio-family situation of the patient, considering factors such as economic situation, family relationships, and social support. The score ranges from 0 to 15, with higher scores indicating greater socio-family vulnerability

  7. Score on the Lubben Social Network Scale

    Time frame: Baseline, 3, 6 Months

    The Lubben Social Network Scale assesses the social support and contact network of an individual, with a score range of 0 to 30. Higher scores indicate a stronger social support network.

  8. Health-Related Quality of Life Measured by EQ-5D-3L

    Time frame: Baseline, 3, 6 Months

    The EQ-5D-3L is a health-related quality of life measurement tool that consists of two parts: a descriptive system covering five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a Visual Analogue Scale (VAS) where participants rate their overall health on a scale from 0 (worst imaginable health) to 100 (best imaginable health). The descriptive system generates a health profile, and the VAS provides a quantitative measure of perceived overall health.

  9. Number of Hospital Admissions

    Time frame: During the 6-month intervention

    The total number of hospital admissions recorded during the 6-month intervention period.

  10. Total Number of Hospitalization Days

    Time frame: During the 6-month intervention

    The total number of days spent in the hospital, summing all admissions during the 6-month intervention period.

  11. Total Number of Emergency Room Admissions

    Time frame: During the 6-month intervention.

    The total number of emergency room admissions recorded during the 6-month intervention period.

  12. Requirement for Admission to Long-Term Care Facilities

    Time frame: During the 6-month intervention.

    This measure tracks whether participants require admission to long-term care facilities during the 6-month intervention period.

  13. Utilization of Social Health Assets

    Time frame: During the 6-month intervention.

    This measure tracks the use of social health services, including community-based resources,

Other outcomes

  1. Adverse Events

    Time frame: During the 6-month intervention.

    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)

Sponsors and collaborators

Lead sponsor

Keralty SAS. Colombia

Other

Collaborators

  • Inter-American Development Bank

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 29, 2024
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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