Clinical trial NCT05610605: Education for Prevention and Treatment of Frailty
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Frail Elderly Syndrome
Keywords: Elderly Persons
Aging
Cost-Efficiency Analysis
Health Education
Lead sponsor: University of Cadiz
Sponsor class: OTHER
Collaborators: name: University of Malaga
name: Instituto de investigación e innovación biomédica de Cádiz
First posted: 2022-11-09
Enrollment: 245
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of the change of baseline Fried frailty criteria at 6 months
timeFrame: Preintervention/Postintervention (0 and 6 months)
measure: Evaluation of the change of baseline Fried frailty criteria at 12 months
timeFrame: Preintervention/Postintervention (0 and 12 months)
measure: Evaluation of the change of baseline weight change at 6 months
timeFrame: Preintervention/Postintervention (0 and 6 months)
measure: Evaluation of the change of baseline weight change at 12 months
timeFrame: Preintervention/Postintervention (0 and 12 months)
measure: Evaluation of the change of baseline exhaustion at 6 months
timeFrame: Preintervention/Postintervention (0 and 6 months)
measure: Evaluation of the change of baseline exhaustion at 12 months
timeFrame: Preintervention/Postintervention (0 and 12 months)
measure: Evaluation of the change of baseline physical activity at 6 months
timeFrame: Preintervention/Postintervention (0 and 6 months)
measure: Evaluation of the change of baseline physical activity at 12 months
timeFrame: Preintervention/Postintervention (0 and 12 months)
measure: Evaluation of the change of baseline walking time at 6 months
timeFrame: Preintervention/Postintervention (0 and 6 months)
measure: Evaluation of the change of baseline walking time at 12 months
timeFrame: Preintervention/Postintervention (0 and 12 months)
measure: Evaluation of the change of baseline muscle weakness at 6 months
timeFrame: Preintervention/Postintervention (0 and 6 months)
measure: Evaluation of the change of baseline muscle weakness at 12 months
timeFrame: Preintervention/Postintervention (0 and 12 months)
Secondary outcomes:
measure: Evaluation of the change of baseline Cognitive status at 6 months
timeFrame: Preintervention/Postintervention (0 and 6 months)
measure: Evaluation of the change of baseline Cognitive status at 12 months
timeFrame: Preintervention/Postintervention (0 and 12 months)
measure: Evaluation of the change of baseline Nutritional status at 6 months
timeFrame: Preintervention/Postintervention (0 and 6 months)
measure: Evaluation of the change of baseline Nutritional status at 12 months
timeFrame: Preintervention/Postintervention (0 and 12 months)
measure: Evaluation of the change of baseline Emotional state at 6 months
timeFrame: Preintervention/Postintervention (0 and 6 months)
measure: Evaluation of the change of baseline Emotional state at 12 months
timeFrame: Preintervention/Postintervention (0 and 12 months)
measure: Evaluation of the change of baseline Sleep quality at 6 months
timeFrame: Preintervention/Postintervention (0 and 6 months)
measure: Evaluation of the change of baseline Sleep quality at 12 months
timeFrame: Preintervention/Postintervention (0 and 12 months)
measure: Evaluation of the change of baseline Social interaction at 6 months
timeFrame: Preintervention/Postintervention (0 and 6 months)
measure: Evaluation of the change of baseline Social interaction at 12 months
timeFrame: Preintervention/Postintervention (0 and 12 months)
measure: Evaluation of the change of baseline Health-related Quality of life at 6 months
timeFrame: Preintervention/Postintervention (0 and 6 months)
measure: Evaluation of the change of baseline Health-related Quality of life at 12 months
timeFrame: Preintervention/Postintervention (0 and 12 months)
measure: Evaluation of the change of baseline Functional capacity in daily life (Lawton & Brody scale and Barthel index) at 6 months
timeFrame: Preintervention/Postintervention (0 and 6 months)
measure: Evaluation of the change of baseline Functional capacity in daily life (Lawton & Brody scale and Barthel index) at 12 months
timeFrame: Preintervention/Postintervention (0 and 12 months)
measure: Evaluation of the change of baseline Functional capacity in daily life (Exercise, physical inactivity and sleep) at 6 months
timeFrame: Preintervention/Postintervention (0 and 6 months)
measure: Evaluation of the change of baseline Functional capacity in daily life (Exercise, physical inactivity and sleep) at 12 months
timeFrame: Preintervention/Postintervention (0 and 12 months)
measure: Evaluation of the change of baseline Functional capacity in daily life (Balance assessment) at 6 months
timeFrame: Preintervention/Postintervention (0 and 6 months)
measure: Evaluation of the change of baseline Functional capacity in daily life (Balance assessment) at 12 months
timeFrame: Preintervention/Postintervention (0 and 12 months)
measure: Evaluation of the change of baseline Adverse outcomes at 6 months
timeFrame: Preintervention/Postintervention (0 and 6 months)
measure: Evaluation of the change of baseline Adverse outcomes at 12 months
timeFrame: Preintervention/Postintervention (0 and 12 months)
measure: Evaluation of the change of baseline self perceived confidence at 6 months
timeFrame: Preintervention/Postintervention (0 and 6 months)
measure: Evaluation of the change of baseline self perceived confidence at 12 months
timeFrame: Preintervention/Postintervention (0 and 12 months)
measure: Evaluation of the change of baseline Cost-utility analysis at 6 months
timeFrame: Preintervention/Postintervention (0 and 6 months)
measure: Evaluation of the change of baseline Cost-utility analysis at 12 months
timeFrame: Preintervention/Postintervention (0 and 12 months)
measure: Evaluation of the change of Intervention satisfaction assessed by CSQ-8 at 6 months
timeFrame: Preintervention/Postintervention (0 and 6 months)
measure: Evaluation of the change of Intervention satisfaction assessed by CSQ-8 at 12 months
timeFrame: Preintervention/Postintervention (0 and 12 months)
measure: Change in Sociodemographic data at 6 months
timeFrame: Preintervention/Postintervention (0 and 6 months)
measure: Change in Sociodemographic data at 12 months
timeFrame: Preintervention/Postintervention (0 and 12 months)
measure: Change in Medical data at 6 months
timeFrame: Preintervention/Postintervention (0 and 6 months)
measure: Change in Medical data at 12 months
timeFrame: Preintervention/Postintervention (0 and 12 months)
measure: Assessed changes from Baseline Blood Sample (Hematocrit) at 6 months
timeFrame: Preintervention/Postintervention (0 and 6 months)
measure: Assessed changes from Baseline Blood Sample (Hematocrit) at 12months
timeFrame: Preintervention/Postintervention (0 and 12 months)
measure: Assessed changes from Baseline Hemoglobin, protein and albumin sample at 6 months
timeFrame: Preintervention/Postintervention (0 and 6 months)
measure: Assessed changes from Baseline Hemoglobin, protein and albumin sample at 12 months
timeFrame: Preintervention/Postintervention (0 and 12 months)
measure: Assessed changes from Baseline lipids, and plasma creatinine sample at 6 months
timeFrame: Preintervention/Postintervention (0 and 6 months)
measure: Assessed changes from Baseline lipids, and plasma creatinine sample at 12 months
timeFrame: Preintervention/Postintervention (0 and 12 months)
measure: Assessed changes from Baseline Blood Sample (Glycosylated hemoglobin) at 6 months
timeFrame: Preintervention/Postintervention (0 and 6 months)
measure: Assessed changes from Baseline Blood Sample (Glycosylated hemoglobin) at 12 months
timeFrame: Preintervention/Postintervention (0 and 12 months)
measure: Assessed changes from Baseline Biological variables: Weight at 6 months
timeFrame: Preintervention/Postintervention (0 and 6 months)
measure: Assessed changes from Baseline Biological variables: Weight at 12months
timeFrame: Preintervention/Postintervention (0 and 12 months)
measure: Assessed changes from Baseline Biological variables: Height at 6 months
timeFrame: Preintervention/Postintervention (0 and 6 months)
measure: Assessed changes from Baseline Biological variables: Height at 12 months
timeFrame: Preintervention/Postintervention (0 and 12 months)
measure: Assessed changes from Baseline Biological variables: Body Mass Index at 6 months
timeFrame: Preintervention/Postintervention (0 and 6 months)
measure: Assessed changes from Baseline Biological variables: Body Mass Index at 12 months
timeFrame: Preintervention/Postintervention (0 and 12 months)
measure: Assessed changes from Baseline Biological variables: Waist circunference at 6 months
timeFrame: Preintervention/Postintervention (0 and 6 months)
measure: Assessed changes from Baseline Biological variables: Waist circunference at 12 months
timeFrame: Preintervention/Postintervention (0 and 12 months)
measure: Assessed changes from Baseline Biological variables: Blood pressure at 6 months
timeFrame: Preintervention/Postintervention (0 and 6 months)
measure: Assessed changes from Baseline Biological variables: Blood pressure at 12 months
timeFrame: Preintervention/Postintervention (0 and 12 months)
measure: Assessed changes from Baseline Smoking and alcohol habits
timeFrame: Preintervention/Postintervention (0 and 6 months)
measure: Assessed changes from Baseline Smoking and alcohol habits
timeFrame: Preintervention/Postintervention (0 and 12 months)
Other outcomes:
Locations:
city: Puerto Real
country: Spain
facility: Faculty of Education
state: Cádiz
Study officials:
affiliation: Universidad de Málaga
name: María Ángeles Vázquez Sanchez, PhD
role: PRINCIPAL_INVESTIGATOR
References: