Effectiveness of a Socio-Community Health Intervention on Pre-Frailty in Older Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: health intervention with a socio-community approach.
- Who it may be relevant to
- Registry conditions: Frail Elderly Syndrome. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness of a Health Intervention With a Socio-community Approach on Frailty in Older Adults With Pre-frailty
Overview
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
- Behavioral health 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 difficu
Primary outcome measures
- Score on the FRAIL Scale [Time frame: Baseline, 3, 6 Months]
Secondary outcome measures (12)
- Barthel Index [Time frame: Baseline, 3, 6 Months]
- Lawton Score [Time frame: Baseline, 3, 6 Months]
- Downton Scale [Time frame: Baseline, 3, 6 Months]
- Score on the Montreal Cognitive Assessment (MoCA) [Time frame: Baseline, 3, 6 Months]
- Score on the Yesavage Geriatric Depression Scale (GDS) [Time frame: Baseline, 3, 6 Months]
- Score on the Gijón Family-Social Assessment Scale [Time frame: Baseline, 3, 6 Months]
- Score on the Lubben Social Network Scale [Time frame: Baseline, 3, 6 Months]
- Health-Related Quality of Life Measured by EQ-5D-3L [Time frame: Baseline, 3, 6 Months]
- Number of Hospital Admissions [Time frame: During the 6-month intervention]
- Total Number of Hospitalization Days [Time frame: During the 6-month intervention]
- Total Number of Emergency Room Admissions [Time frame: During the 6-month intervention.]
- Requirement for Admission to Long-Term Care Facilities [Time frame: During the 6-month intervention.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06663150 · 092-24 UNV