Frail Elderly Syndrome
Conditions
Keywords
Prefrailty, Frailty, Older Adults
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.
Interventions
BEHAVIORALhealth intervention with a socio-community approach
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.
Sponsors
Keralty SAS. Colombia
Inter-American Development Bank
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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, |
Countries
Colombia
Contacts
STUDY_CHAIRLina Sofía Morón-Duarte, PhD
keralty
Outcome results
None listed