Education for Prevention and Treatment of Frailty (FRAGSALUD)

University of Cadiz

Status: Completed

Conditions: Frailty; Frail Elderly Syndrome

Treatments: Other: Health intervention programme: FRAGSALUD

Study type: Interventional

Funder types: Other

Identifiers

NCT05610605

FRAGSALUD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 235 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients over 65 years of age who present frailty or pre-frailty, assessed using the Fried criteria adapted to Spanish population;
• Patients belonging to Clinical Management Units participating in the study and who will remain in it for the 15 months of the study;
• Patients who can come to the Health Center alone or accompanied.

Exclusion criteria

• Patients with no full control of their capabilities.
• Patients who do not understand Spanish;
• Patients with allergies to plastic or metal.
• Patients who are instutionalized.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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235 participants in 2 patient groups

Control Group

No Intervention group

Description:

Participants who do not receive attention from the Fragsalud program. The control group follows the usual care and preventive measures in Primary Care, according to different protocols implemented and the criteria of nurses and family doctors responsible for their care.

Intervention Group

Experimental group

Description:

The FRAGSALUD Programme is a multidomain intervention programme, which covers the prevention and treatment of frailty from different aspects, fundamentally from a physical and cognitive aspect and to maintain social integration, although other modifiable factors that are related to the presence of fragility such as hearing impairment, visual deficit or depression.

Treatment:

Other: Health intervention programme: FRAGSALUD