Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-24 @ 4:46 PM
Study NCT ID:
NCT06663150
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-29
First Post:
2024-10-24
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of a Socio-Community Health Intervention on Pre-Frailty in Older Adults
Sponsor:
Keralty SAS. Colombia
Organization:
Study Overview
Official Title:
Effectiveness of a Health Intervention With a Socio-community Approach on Frailty in Older Adults With Pre-frailty
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: