Effectiveness of a Socio-Community Health Intervention on Pre-Frailty in Older Adults
- Conditions
- Frail Elderly Syndrome
- Registration Number
- NCT06663150
- Lead Sponsor
- Keralty SAS. Colombia
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 160
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Score on the FRAIL Scale 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 Outcome Measures
Name Time Method Barthel Index 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.
Lawton Score 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.
Downton Scale 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.
Score on the Montreal Cognitive Assessment (MoCA) 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
Score on the Yesavage Geriatric Depression Scale (GDS) 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.
Score on the Gijón Family-Social Assessment Scale 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
Score on the Lubben Social Network Scale 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.
Health-Related Quality of Life Measured by EQ-5D-3L 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.
Number of Hospital Admissions During the 6-month intervention The total number of hospital admissions recorded during the 6-month intervention period.
Total Number of Hospitalization Days During the 6-month intervention The total number of days spent in the hospital, summing all admissions during the 6-month intervention period.
Total Number of Emergency Room Admissions During the 6-month intervention. The total number of emergency room admissions recorded during the 6-month intervention period.
Requirement for Admission to Long-Term Care Facilities During the 6-month intervention. This measure tracks whether participants require admission to long-term care facilities during the 6-month intervention period.
Utilization of Social Health Assets During the 6-month intervention. This measure tracks the use of social health services, including community-based resources,