Skip to main content
OpenTrials
Completed

NCT Number: NCT05610605

Education for Prevention and Treatment of Frailty

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Frailty Adherence Interventions Behavior Frail Elderly Syndrome Health Behavior Health Education Medication Adherence Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Education

Puerto Real, Cádiz, 11519, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Evaluation of the Change of Baseline Fried Frailty Criteria at 6 Months

    Time frame: Preintervention/Postintervention (0 and 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

  2. Evaluation of the Change of Baseline Fried Frailty Criteria at 12 Months

    Time frame: Preintervention/Retest (0 and 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

Sponsors and collaborators

Lead sponsor

University of Cadiz

Other

Collaborators

  • Instituto de investigación e innovación biomédica de Cádiz
  • University of Malaga

Registry information

Official study 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

Acronym: FRAGSALUD

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 9, 2022
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.