NCT05610605

Education for Prevention and Treatment of Frailty

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 235 (actual)
• Sponsor: University of Cadiz · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Frailty
• Frail Elderly Syndrome

Interventions

Type	Name	Description
OTHER	Health intervention programme: FRAGSALUD	The FRAGSALUD Program consists in two parts, a first part of health education that will be taught in a group in four sessions, and a second part of individual treatment and follow-up, individual consultations will have a bimonthly periodicity until reaching one year, at which time that the program ends and a final evaluation will be carried out to assess whether the changes are maintained 15 months after the start.

Timeline

• Start date: 2022-03-30
• Primary completion: 2023-09-01
• Completion: 2023-09-30
• First posted: 2022-11-09
• Last updated: 2025-12-02
• Results posted: 2025-12-02

Locations

1 site across 1 country: Spain