Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT05610605
Status:
COMPLETED
Last Update Posted:
2025-12-02
First Post:
2022-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Education for Prevention and Treatment of Frailty
Sponsor:
University of Cadiz
Organization:
Study Overview
Official Title:
Randomized Clinical Trial to Assess the Efficacy of an Educational Programme for Prevention and Treatment of Frailty in Older Adults Living in the Community: FRAGSALUD Programme
Status:
COMPLETED
Status Verified Date:
2022-02
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:
FRAGSALUD
Brief Summary:
Frailty is a condition with a high prevalence in older adults, leading to higher vulnerability and increasing the risk of adverse health outcomes and disabilities. The aging of the population in Spain is accelerating quickly, consequently, it is necessary to advise the population on the appropriate path to healthy aging, free of fragility and their secondary problems.
Detailed Description:
To evaluate the efficacy and efficiency of a Fragsalud program for the prevention and multifactorial treatment of frailty in people over 65 years of age living in the community compared to the usual treatment. Material and methods: A Single blind randomized, two-arm clinical trial; control group and intervention group, multicenter, with 15 months of follow-up, with evaluations blinded at the beginning, and in the follow-up at 12 and 15 months. A recruitment of 196 people over 65 years of age with criteria of pre-frailty or frailty according to Fried's criteria. The Fragsalud education program will be taught in the intervention group; while control group will follow the usual health care. The evolution of the criteria of frailty, cognitive state, eating pattern, emotional state, quality of sleep, perceived social support, quality of life, functional capacity in daily life, adverse results, assessment of self-efficacy and cost-utility analysis variables will be evaluated. Possible confounding factors such as sociodemographic variables, comorbidity and polymedication will be controlled. Intention-to-treat analysis will be performed.
Study Oversight
Has Oversight DMC:
False
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?: