Frail Elderly SyndromeNCT06663150
Effectiveness of a Socio-Community Health Intervention on Pre-Frailty in Older Adults
A study testing health intervention with a socio-community approach in people with Frail Elderly Syndrome, run by Keralty SAS. Colombia at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Frail Elderly Syndrome
- What is being tested?
- health intervention with a socio-community approach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteColombia
- Study dates
- 25 Mar 2025to 26 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Health Intervention With a Socio-community Approach on Frailty in Older Adults With Pre-frailty
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:
Read more
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.
- Conditions
- Frail Elderly Syndrome
- Being tested
- health intervention with a socio-community approach
- Keywords
- Prefrailty, Frailty, Older Adults
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
health intervention with a socio-community approachBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Education Component: Lectures and workshops aimed at enhancing awareness and personal growth through knowledge and emotional reflection.
Cognitive Component: One-hour sessions divided into introduction (15 min), cognitive stimulation activities (35 min), and closure with reflection and a brief survey.
Physical Activity Component: A 10-minute warm-up, followed by 30 minutes of guided exercises for balance, coordination, and strength, ending with a 10-minute cool-down.
Nutrition Component: Practical workshops focused on healthy eating, including menu planning and food preparation.
Socio-Community and Occupational Component: Encourages community integration and social networking, with gardening activities for growing herbs and vegetables.
Autonomous Activities: Participants implement physical activity recommendations in daily life, with weekly follow-ups by the research team using the RedCap platform for monitoring. Receives: Behavioral: health intervention with a socio-community approach |
| Control group | No intervention | The control group will maintain the usual care provided by their healthcare service provider. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on the FRAIL Scale
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
Measured: Baseline, 3, 6 Months
Secondary outcomes (13)
Barthel Index
Measures independence in basic activities of daily living. The score ranges from 0 to 100, where higher scores indicate greater independence.
Measured: Baseline, 3, 6 Months
Lawton Score
Assesses instrumental activities of daily living (IADLs), with a score range of 0 to 8. Higher scores indicate better ability to perform IADLs independently.
Measured: Baseline, 3, 6 Months
Downton Scale
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.
Measured: Baseline, 3, 6 Months
Score on the Montreal Cognitive Assessment (MoCA)
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
Measured: Baseline, 3, 6 Months
Score on the Yesavage Geriatric Depression Scale (GDS)
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.
Measured: Baseline, 3, 6 Months
Score on the Gijón Family-Social Assessment Scale
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
Measured: Baseline, 3, 6 Months
Score on the Lubben Social Network Scale
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.
Measured: Baseline, 3, 6 Months
Health-Related Quality of Life Measured by EQ-5D-3L
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.
Measured: Baseline, 3, 6 Months
Number of Hospital Admissions
The total number of hospital admissions recorded during the 6-month intervention period.
Measured: During the 6-month intervention
Total Number of Hospitalization Days
The total number of days spent in the hospital, summing all admissions during the 6-month intervention period.
Measured: During the 6-month intervention
Total Number of Emergency Room Admissions
The total number of emergency room admissions recorded during the 6-month intervention period.
Measured: During the 6-month intervention.
Requirement for Admission to Long-Term Care Facilities
This measure tracks whether participants require admission to long-term care facilities during the 6-month intervention period.
Measured: During the 6-month intervention.
Utilization of Social Health Assets
This measure tracks the use of social health services, including community-based resources,
Measured: During the 6-month intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start25 Mar 2025
- Primary completion25 Jun 2026
- Study completion26 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail Elderly SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keralty SAS. Colombia
- Sponsor type
- University, hospital or other
- Collaborators
- Inter-American Development Bank
- Responsible party
- Sponsor
- Investigators
- Lina Sofía Morón-Duarte, PhD, Study chair, keralty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06663150
- Sponsor's protocol ID
- 092-24 UNV
- Status last verified
- Sep 2026
- First submitted
- 24 Oct 2024
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Health Intervention With a Socio-community Approach on Frailty in Older Adults With Pre-frailty
- ClinicalTrials.gov ID
- NCT06663150
- Acronym / sponsor ID
- 092-24 UNV
- Conditions
- Frail Elderly Syndrome
- Keywords
- Prefrailty, Frailty, Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Keralty SAS. ColombiaUniversity, hospital or other
- Collaborators
- Inter-American Development Bank
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 25 Jun 2026 (actual)
- Study completion
- 26 Jun 2026 (actual)
- First posted
- 29 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: health intervention with a socio-community approachEducation Component: Lectures and workshops aimed at enhancing awareness and personal growth through knowledge and emotional reflection. Cognitive Component: One-hour sessions divided into introduction (15 min), cognitive stimulation activities (35 min), and closure with reflection and a brief survey. Physical Activity Component: A 10-minute warm-up, followed by 30 minutes of guided exercises for balance, coordination, and strength, ending with a 10-minute cool-down. Nutrition Component: Practical workshops focused on healthy eating, including menu planning and food preparation. Socio-Community and Occupational Component: Encourages community integration and social networking, with gardening activities for growing herbs and vegetables. Autonomous Activities: Participants implement physical activity recommendations in daily life, with weekly follow-ups by the research team using the RedCap platform for monitoring. |
| Control group | No intervention | –The control group will maintain the usual care provided by their healthcare service provider. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| health intervention with a socio-community approachThe 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. | Behavioural | Experimental group |
Primary outcome
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
13 secondary outcomes
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.
Utilization of Social Health Assets
Time frame: During the 6-month intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lina Sofía Morón-Duarte, PhD study chair
keralty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing health intervention with a socio-community approach in people with Frail Elderly Syndrome, run by Keralty SAS. Colombia at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on the FRAIL Scale (time frame: Baseline, 3, 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.