Education for Prevention and Treatment of Frailty

NCT05610605 | Completed Results

• 1 other identifier: FRAGSALUD
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty; Frail Elderly Syndrome

Keywords

Elderly Persons; Aging; Cost-Efficiency Analysis; Health Education

Outcome Measures

Primary Outcomes (2)

• Evaluation of the Change of Baseline Fried Frailty Criteria at 6 Months

  Assessment of frailty using the Fried Frailty Phenotype. This is a five-component measure used to classify frailty status (unintentional weight loss, exhaustion, weakness, slow walking speed, and low physical activity). A score of 1 is assigned for each criterion met, yielding a total score that ranges from 0 to 5. A higher score indicates a worse outcome (greater frailty). 0 = Robust (non-frail) 1-2 = Pre-frail 3-5 = Frail

  Preintervention/Postintervention (0 and 6 months)

• Evaluation of the Change of Baseline Fried Frailty Criteria at 12 Months

  Assessment of frailty using the Fried Frailty Phenotype. This is a five-component measure used to classify frailty status (unintentional weight loss, exhaustion, weakness, slow walking speed, and low physical activity). A score of 1 is assigned for each criterion met, yielding a total score that ranges from 0 to 5. A higher score indicates a worse outcome (greater frailty). 0 = Robust (non-frail) 1-2 = Pre-frail 3-5 = Frail

  Preintervention/Retest (0 and 12 months)

Study Arms (2)

Control Group

NO INTERVENTION

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

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.

Other: Health intervention programme: FRAGSALUD

Interventions

Health intervention programme: FRAGSALUD OTHER

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.

Intervention Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cadiz: lead
• University of Malaga: collaborator
• Instituto de investigación e innovación biomédica de Cádiz: collaborator

Study Sites (1)

Faculty of Education

Puerto Real, Cádiz, 11519, Spain

Location

Related Publications (4)

• Gonzalez-Mariscal A, Corral-Perez J, Vazquez-Sanchez MA, Avila-Cabeza-de-Vaca L, Costilla M, Casals C. Benefits of an educational intervention on functional capacity in community-dwelling older adults with frailty phenotype: A randomized controlled trial. Int J Nurs Stud. 2025 Feb;162:104955. doi: 10.1016/j.ijnurstu.2024.104955. Epub 2024 Nov 9.

  PMID: 39579605 DERIVED

• Corral-Perez J, Vazquez-Sanchez MA, Casals-Sanchez JL, Contreras-Garcia FJ, Costilla M, Casals C. A 6-month educational program improves sleep behaviour in community-dwelling frail older adults: A randomised controlled trial. Sleep Med. 2024 Sep;121:196-202. doi: 10.1016/j.sleep.2024.07.011. Epub 2024 Jul 10.

  PMID: 39002328 DERIVED

• Casals C, Corral-Perez J, Avila-Cabeza-de-Vaca L, Gonzalez-Mariscal A, Carrion-Velasco Y, Rodriguez-Martinez MC, Jimenez-Cebrian AM, Vazquez-Sanchez MA. Exploring the interplay of frailty, physical function, physical activity, nutritional status, and their association with quality of life and depressive symptoms in older adults with the frailty phenotype. Int J Geriatr Psychiatry. 2024 Mar;39(3):e6078. doi: 10.1002/gps.6078.

  PMID: 38470426 DERIVED

• Corral-Perez J, Casals C, Avila-Cabeza-de-Vaca L, Gonzalez-Mariscal A, Mier A, Espinar-Toledo M, Garcia-Agua Soler N, Vazquez-Sanchez MA. Associations Between Physical Activity and Inactivity Levels on Physical Function and Sleep Parameters of Older Adults With Frailty Phenotype. J Appl Gerontol. 2024 Jul;43(7):910-921. doi: 10.1177/07334648231218095. Epub 2023 Dec 1.

  PMID: 38038169 DERIVED

MeSH Terms

Conditions

Frailty; Health Education

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Cristina Casals
• Organization: University of Cadiz

cristina.casals@uca.es

956016216

Study Officials

• María Ángeles Vázquez Sanchez, PhD

  Universidad de Málaga

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: November 9, 2022
• Study Start: March 30, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 30, 2023
• Last Updated: December 2, 2025
• Results First Posted: December 2, 2025

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)