Clinical trial NCT06663150: Effectiveness of a Socio-Community Health Intervention on Pre-Frailty in Older Adults
Official title: Effectiveness of a Health Intervention With a Socio-community Approach on Frailty in Older Adults With Pre-frailty
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Frail Elderly Syndrome
Keywords: Prefrailty
Frailty
Older Adults
Lead sponsor: Keralty SAS. Colombia
Sponsor class: OTHER
Collaborators: name: Inter-American Development Bank
First posted: 2024-10-29
Enrollment: 160
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Score on the FRAIL Scale
timeFrame: Baseline, 3, 6 Months
Secondary outcomes:
measure: Barthel Index
timeFrame: Baseline, 3, 6 Months
measure: Lawton Score
timeFrame: Baseline, 3, 6 Months
measure: Downton Scale
timeFrame: Baseline, 3, 6 Months
measure: Score on the Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline, 3, 6 Months
measure: Score on the Yesavage Geriatric Depression Scale (GDS)
timeFrame: Baseline, 3, 6 Months
measure: Score on the Gijón Family-Social Assessment Scale
timeFrame: Baseline, 3, 6 Months
measure: Score on the Lubben Social Network Scale
timeFrame: Baseline, 3, 6 Months
measure: Health-Related Quality of Life Measured by EQ-5D-3L
timeFrame: Baseline, 3, 6 Months
measure: Number of Hospital Admissions
timeFrame: During the 6-month intervention
measure: Total Number of Hospitalization Days
timeFrame: During the 6-month intervention
measure: Total Number of Emergency Room Admissions
timeFrame: During the 6-month intervention.
measure: Requirement for Admission to Long-Term Care Facilities
timeFrame: During the 6-month intervention.
measure: Utilization of Social Health Assets
timeFrame: During the 6-month intervention.
Other outcomes:
measure: Adverse Events
timeFrame: During the 6-month intervention.
Locations:
Study officials:
affiliation: keralty
name: Lina Sofía Morón-Duarte, PhD
role: STUDY_CHAIR
References: