Education for Prevention and Treatment of Frailty (FRAGSALUD)

November 18, 2025 updated by: University of Cadiz

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

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.

Study Overview

Status

Completed

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.

Study Type

Interventional

Enrollment (Actual)

235

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Cádiz
      • Puerto Real, Cádiz, Spain, 11519
        • Faculty of Education

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
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.
Experimental: Intervention Group
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

Preintervention/Postintervention (0 and 6 months)
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

Preintervention/Retest (0 and 12 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the change of baseline Cognitive status at 6 months
Time Frame: Preintervention/Postintervention (0 and 6 months)

- Cognitive status will be evaluated using The Short Portable Mental Status Questionnaire (SPMSQ) which includes 10 items. Depending on the number of errors, participants will be stratified in: 0-2 errors: normal mental functioning

3-4 errors: mild cognitive impairment

5-7 errors: moderate cognitive impairment

8 or more errors: severe cognitive impairment

Preintervention/Postintervention (0 and 6 months)
Evaluation of the change of baseline Cognitive status at 12 months
Time Frame: Preintervention/Postintervention (0 and 12 months)

- Cognitive status will be evaluated using The Short Portable Mental Status Questionnaire (SPMSQ) which includes 10 items. Depending on the number of errors, participants will be stratified in: 0-2 errors: normal mental functioning

3-4 errors: mild cognitive impairment

5-7 errors: moderate cognitive impairment

8 or more errors: severe cognitive impairment

Preintervention/Postintervention (0 and 12 months)
Evaluation of the change of baseline Nutritional status at 6 months
Time Frame: Preintervention/Postintervention (0 and 6 months)
- Nutritional status: the eating pattern will be assessed using the Mini Nutritional Assessment (MNA) test, which is a nutritional assessment and screening method for the elderly population. It consists of two parts: a screening (7 questions), and an evaluation (12 questions). A total score ≥ 24 indicates good nutritional status, between 17-23.5 identifies nutritional risk, and less than 17 the patient presents protein-calorie malnutrition.
Preintervention/Postintervention (0 and 6 months)
Evaluation of the change of baseline Nutritional status at 12 months
Time Frame: Preintervention/Postintervention (0 and 12 months)
- Nutritional status: the eating pattern will be assessed using the Mini Nutritional Assessment (MNA) test, which is a nutritional assessment and screening method for the elderly population. It consists of two parts: a screening (7 questions), and an evaluation (12 questions). A total score ≥ 24 indicates good nutritional status, between 17-23.5 identifies nutritional risk, and less than 17 the patient presents protein-calorie malnutrition.
Preintervention/Postintervention (0 and 12 months)
Evaluation of the change of baseline Emotional state at 6 months
Time Frame: Preintervention/Postintervention (0 and 6 months)
- Emotional state: using the Yesavage geriatric depression scale. It is a questionnaire for depression screening in people over 65 years of age. It consists of 15 questions, each wrong answer scores 1. The cut-off points are: 0-4 normal and 5 or + depression.
Preintervention/Postintervention (0 and 6 months)
Evaluation of the change of baseline Emotional state at 12 months
Time Frame: Preintervention/Postintervention (0 and 12 months)
- Emotional state: using the Yesavage geriatric depression scale. It is a questionnaire for depression screening in people over 65 years of age. It consists of 15 questions, each wrong answer scores 1. The cut-off points are: 0-4 normal and 5 or + depression.
Preintervention/Postintervention (0 and 12 months)
Evaluation of the change of baseline Sleep quality at 6 months
Time Frame: Preintervention/Postintervention (0 and 6 months)
- Self-perceived sleep quality using the Pittsburgh Sleep Quality Index (PSQI), validated in Spanish. 7 components are obtained: subjective quality, sleep latency, sleep duration, "sleep efficiency", sleep disturbances, use of hypnotic medication, daytime dysfunction. The sum of the partial scores generates a total score, which can range from 0-21. According to Buysse et al, a score of 5 would be the cut-off point that would separate subjects who have good sleep quality from those who have poor sleep quality.
Preintervention/Postintervention (0 and 6 months)
Evaluation of the change of baseline Sleep quality at 12 months
Time Frame: Preintervention/Postintervention (0 and 12 months)
- Self-perceived sleep quality using the Pittsburgh Sleep Quality Index (PSQI), validated in Spanish. 7 components are obtained: subjective quality, sleep latency, sleep duration, "sleep efficiency", sleep disturbances, use of hypnotic medication, daytime dysfunction. The sum of the partial scores generates a total score, which can range from 0-21. According to Buysse et al, a score of 5 would be the cut-off point that would separate subjects who have good sleep quality from those who have poor sleep quality.
Preintervention/Postintervention (0 and 12 months)
Evaluation of the change of baseline Social interaction at 6 months
Time Frame: Preintervention/Postintervention (0 and 6 months)
- Social interaction through the Duke-UNC questionnaire of perceived social support, consisting of 11 items and a Likert-type response scale (1-5). The scoring range is between 11 and 55 points. The lower the score, the less support. In the Spanish validation, a cut-off point of <32 was chosen. A score equal to or greater than 32 indicates normal support, while less than 32 indicates low perceived social support.
Preintervention/Postintervention (0 and 6 months)
Evaluation of the change of baseline Social interaction at 12 months
Time Frame: Preintervention/Postintervention (0 and 12 months)
- Social interaction through the Duke-UNC questionnaire of perceived social support, consisting of 11 items and a Likert-type response scale (1-5). The scoring range is between 11 and 55 points. The lower the score, the less support. In the Spanish validation, a cut-off point of <32 was chosen. A score equal to or greater than 32 indicates normal support, while less than 32 indicates low perceived social support.
Preintervention/Postintervention (0 and 12 months)
Evaluation of the change of baseline Functional capacity in daily life (Lawton & Brody scale and Barthel index) at 6 months
Time Frame: Preintervention/Postintervention (0 and 6 months)
- Evaluation of functional capacities for personal independence, using the Lawton and Brody scale, which evaluates 8 instrumental activities of daily life in 10 Likert-type items. Depending on the degree of dependence, every item is scored between 0 to 10, with a final puntuation between 0 to 100. Depending on the final score, the degree of dependency is evaluated with the lower the score, the more dependency.
Preintervention/Postintervention (0 and 6 months)
Evaluation of the change of baseline Functional capacity in daily life (Lawton & Brody scale and Barthel index) at 12 months
Time Frame: Preintervention/Postintervention (0 and 12 months)
- Evaluation of functional capacities for personal independence, using the Lawton and Brody scale, which evaluates 8 instrumental activities of daily life in 10 Likert-type items. Depending on the degree of dependence, every item is scored between 0 to 10, with a final puntuation between 0 to 100. Depending on the final score, the degree of dependency is evaluated with the lower the score, the more dependency.
Preintervention/Postintervention (0 and 12 months)
Evaluation of the change of baseline Functional capacity in daily life (Exercise, physical inactivity and sleep) at 6 months
Time Frame: Preintervention/Postintervention (0 and 6 months)
- Assessment of exercise, physical inactivity and sleep that will be carried out using accelerometers for 7 days at the beginning, a year and 15 months. Participants are asked to wear a triaxial accelerometer (GeneActiv, Activinsights Ltd, Kimbolton, Cambs, UK, http://www.geneactiv.org/) on their non-dominant wrist 24 hours a day. The GeneActiv Recorder contains a triaxial MEMS accelerometer with a range of ± 8 g. and a sensitivity ≥ 0.004 g. It records both motion-related acceleration and gravitational acceleration and has linear and equal sensitivity along all three axes (forward/backward, up/down, left/right). This monitor provides the end user with raw accelerometry data. In this study, the accelerometer will be configured at 40 Hz. For data processing, the system developed for the PREDIMEDPLUS study will be used. The data processing is done with an open source package in R, GGIR version 1.5-12.
Preintervention/Postintervention (0 and 6 months)
Evaluation of the change of baseline Functional capacity in daily life (Exercise, physical inactivity and sleep) at 12 months
Time Frame: Preintervention/Postintervention (0 and 12 months)
- Assessment of exercise, physical inactivity and sleep that will be carried out using accelerometers for 7 days at the beginning, a year and 15 months. Participants are asked to wear a triaxial accelerometer (GeneActiv, Activinsights Ltd, Kimbolton, Cambs, UK, http://www.geneactiv.org/) on their non-dominant wrist 24 hours a day. The GeneActiv Recorder contains a triaxial MEMS accelerometer with a range of ± 8 g. and a sensitivity ≥ 0.004 g. It records both motion-related acceleration and gravitational acceleration and has linear and equal sensitivity along all three axes (forward/backward, up/down, left/right). This monitor provides the end user with raw accelerometry data. In this study, the accelerometer will be configured at 40 Hz. For data processing, the system developed for the PREDIMEDPLUS study will be used. The data processing is done with an open source package in R, GGIR version 1.5-12.
Preintervention/Postintervention (0 and 12 months)
Evaluation of the change of baseline Functional capacity in daily life (Balance assessment) at 6 months
Time Frame: Preintervention/Postintervention (0 and 6 months)
- Assessment of balance by means of single-legged support, it will be requested that they remain as long as possible supported by only one of their lower extremities with their arms at the sides of the trunk. The duration of the test will be considered until one of the following conditions is met: a) The support foot changes position, b) The elevated foot touches the ground, c) The arms come off the trunk, and d) When the leg raised touches the supporting limb. The maximum time considered is 30 seconds. The best time of two attempts will be recorded. Based on the results, the subjects will be divided into two groups. Those who reach a time >5 seconds that will be classified as high performance, and with a score ≤ 5 low performance.
Preintervention/Postintervention (0 and 6 months)
Evaluation of the change of baseline Functional capacity in daily life (Balance assessment) at 12 months
Time Frame: Preintervention/Postintervention (0 and 12 months)
- Assessment of balance by means of single-legged support, it will be requested that they remain as long as possible supported by only one of their lower extremities with their arms at the sides of the trunk. The duration of the test will be considered until one of the following conditions is met: a) The support foot changes position, b) The elevated foot touches the ground, c) The arms come off the trunk, and d) When the leg raised touches the supporting limb. The maximum time considered is 30 seconds. The best time of two attempts will be recorded. Based on the results, the subjects will be divided into two groups. Those who reach a time >5 seconds that will be classified as high performance, and with a score ≤ 5 low performance.
Preintervention/Postintervention (0 and 12 months)
Evaluation of the change of baseline Adverse outcomes at 6 months
Time Frame: Preintervention/Postintervention (0 and 6 months)
- Evaluate the rates of falls, fractures due to falls, hospital admissions, days of hospital admission, interventions, inclusions in home care programs, institutionalizations in residences and deaths. The evaluation will be carried out by consulting the clinical health history and by direct questioning.
Preintervention/Postintervention (0 and 6 months)
Evaluation of the change of baseline Adverse outcomes at 12 months
Time Frame: Preintervention/Postintervention (0 and 12 months)
- Evaluate the rates of falls, fractures due to falls, hospital admissions, days of hospital admission, interventions, inclusions in home care programs, institutionalizations in residences and deaths. The evaluation will be carried out by consulting the clinical health history and by direct questioning.
Preintervention/Postintervention (0 and 12 months)
Evaluation of the change of baseline self perceived confidence at 6 months
Time Frame: Preintervention/Postintervention (0 and 6 months)
- Evaluation of self-efficacy using the General Self-Efficacy Scale. Consisting of 10 items on a Likert scale ranging from 1 (not at all) to 4 (a lot), the scale assesses the degree to which they perceive self-confidence when managing general activities in daily life. It was developed by Sherer et al., it is validated in Spanish.
Preintervention/Postintervention (0 and 6 months)
Evaluation of the change of baseline self perceived confidence at 12 months
Time Frame: Preintervention/Postintervention (0 and 12 months)
- Evaluation of self-efficacy using the General Self-Efficacy Scale. Consisting of 10 items on a Likert scale ranging from 1 (not at all) to 4 (a lot), the scale assesses the degree to which they perceive self-confidence when managing general activities in daily life. It was developed by Sherer et al., it is validated in Spanish.
Preintervention/Postintervention (0 and 12 months)
Evaluation of the change of baseline Cost-utility analysis at 6 months
Time Frame: Preintervention/Postintervention (0 and 6 months)

- Cost-utility analysis, following the recommendations of the proposed guide for economic evaluation applied to health technologies.

Healthcare resources: a) the consumption of healthcare services associated with falls will be analysed: hospital admissions, Primary Care medical and nursing consultations, Primary Care medical and nursing visits at home (during regular hours), emergency medical visits for Primary Care Primary at home, medical consultations in the Hospital (UGC Traumatology and Rehabilitation), emergency medical consultations in the Hospital Center, medication and complementary tests; b) the consumption of services in general will also be analysed: visits to primary nursing and medical care, visits to primary nursing and medical care, visits to the emergency department, visits to medical specialties, hospital admissions and surgical interventions.

Preintervention/Postintervention (0 and 6 months)
Evaluation of the change of baseline Cost-utility analysis at 12 months
Time Frame: Preintervention/Postintervention (0 and 12 months)

- Cost-utility analysis, following the recommendations of the proposed guide for economic evaluation applied to health technologies.

Healthcare resources: a) the consumption of healthcare services associated with falls will be analysed: hospital admissions, Primary Care medical and nursing consultations, Primary Care medical and nursing visits at home (during regular hours), emergency medical visits for Primary Care Primary at home, medical consultations in the Hospital (UGC Traumatology and Rehabilitation), emergency medical consultations in the Hospital Center, medication and complementary tests; b) the consumption of services in general will also be analysed: visits to primary nursing and medical care, visits to primary nursing and medical care, visits to the emergency department, visits to medical specialties, hospital admissions and surgical interventions.

Preintervention/Postintervention (0 and 12 months)
Evaluation of the change of Intervention satisfaction assessed by CSQ-8 at 6 months
Time Frame: Preintervention/Postintervention (0 and 6 months)
- Evaluation of satisfaction with the intervention: the CSQ-8 (Client Satisfaction Questionnaire) will be used, with 8 questions evaluated according to a 4-point Likert-type scale, with specific cut-off points for each of the items. It has been validated in a Spanish-speaking population.
Preintervention/Postintervention (0 and 6 months)
Evaluation of the change of Intervention satisfaction assessed by CSQ-8 at 12 months
Time Frame: Preintervention/Postintervention (0 and 12 months)
- Evaluation of satisfaction with the intervention: the CSQ-8 (Client Satisfaction Questionnaire) will be used, with 8 questions evaluated according to a 4-point Likert-type scale, with specific cut-off points for each of the items. It has been validated in a Spanish-speaking population.
Preintervention/Postintervention (0 and 12 months)
Change in Sociodemographic data at 6 months
Time Frame: Preintervention/Postintervention (0 and 6 months)
Date of birth, sex, marital status, cohabitation, educational level, amount of pension income.
Preintervention/Postintervention (0 and 6 months)
Change in Sociodemographic data at 12 months
Time Frame: Preintervention/Postintervention (0 and 12 months)
Date of birth, sex, marital status, cohabitation, educational level, amount of pension income.
Preintervention/Postintervention (0 and 12 months)
Change in Medical data at 6 months
Time Frame: Preintervention/Postintervention (0 and 6 months)
Number and type of chronic pathologies (comorbidities). Number of different medications you take daily and type of medication.
Preintervention/Postintervention (0 and 6 months)
Change in Medical data at 12 months
Time Frame: Preintervention/Postintervention (0 and 12 months)
Number and type of chronic pathologies (comorbidities). Number of different medications you take daily and type of medication.
Preintervention/Postintervention (0 and 12 months)
Assessed changes from Baseline Blood Sample (Hematocrit) at 6 months
Time Frame: Preintervention/Postintervention (0 and 6 months)
1. Hematocrit (%)
Preintervention/Postintervention (0 and 6 months)
Assessed changes from Baseline Blood Sample (Hematocrit) at 12months
Time Frame: Preintervention/Postintervention (0 and 12 months)
1. Hematocrit (%)
Preintervention/Postintervention (0 and 12 months)
Assessed changes from Baseline Hemoglobin, protein and albumin sample at 6 months
Time Frame: Preintervention/Postintervention (0 and 6 months)
2. Hemoglobin (g/dL) 3. Total protein (g/dL) 4. Serum Albumin (g/dL)
Preintervention/Postintervention (0 and 6 months)
Assessed changes from Baseline Hemoglobin, protein and albumin sample at 12 months
Time Frame: Preintervention/Postintervention (0 and 12 months)
2. Hemoglobin (g/dL) 3. Total protein (g/dL) 4. Serum Albumin (g/dL)
Preintervention/Postintervention (0 and 12 months)
Assessed changes from Baseline lipids, and plasma creatinine sample at 6 months
Time Frame: Preintervention/Postintervention (0 and 6 months)
5. Lipid profile (mg/dL) 6. Plasma creatinine (mg/dL)
Preintervention/Postintervention (0 and 6 months)
Assessed changes from Baseline lipids, and plasma creatinine sample at 12 months
Time Frame: Preintervention/Postintervention (0 and 12 months)
5. Lipid profile (mg/dL) 6. Plasma creatinine (mg/dL)
Preintervention/Postintervention (0 and 12 months)
Assessed changes from Baseline Blood Sample (Glycosylated hemoglobin) at 6 months
Time Frame: Preintervention/Postintervention (0 and 6 months)
7. Glycosylated hemoglobin (A1C)
Preintervention/Postintervention (0 and 6 months)
Assessed changes from Baseline Blood Sample (Glycosylated hemoglobin) at 12 months
Time Frame: Preintervention/Postintervention (0 and 12 months)
7. Glycosylated hemoglobin (A1C)
Preintervention/Postintervention (0 and 12 months)
Assessed changes from Baseline Biological variables: Weight at 6 months
Time Frame: Preintervention/Postintervention (0 and 6 months)
1. Weight (kilograms)
Preintervention/Postintervention (0 and 6 months)
Assessed changes from Baseline Biological variables: Weight at 12months
Time Frame: Preintervention/Postintervention (0 and 12 months)
1. Weight (kilograms)
Preintervention/Postintervention (0 and 12 months)
Assessed changes from Baseline Biological variables: Height at 6 months
Time Frame: Preintervention/Postintervention (0 and 6 months)
2. Height (meters)
Preintervention/Postintervention (0 and 6 months)
Assessed changes from Baseline Biological variables: Height at 12 months
Time Frame: Preintervention/Postintervention (0 and 12 months)
2. Height (meters)
Preintervention/Postintervention (0 and 12 months)
Assessed changes from Baseline Biological variables: Body Mass Index at 6 months
Time Frame: Preintervention/Postintervention (0 and 6 months)
3. Body Mass Index (kg/m^2)
Preintervention/Postintervention (0 and 6 months)
Assessed changes from Baseline Biological variables: Body Mass Index at 12 months
Time Frame: Preintervention/Postintervention (0 and 12 months)
3. Body Mass Index (kg/m^2)
Preintervention/Postintervention (0 and 12 months)
Assessed changes from Baseline Biological variables: Waist circunference at 6 months
Time Frame: Preintervention/Postintervention (0 and 6 months)
4. Waist circunference (cm)
Preintervention/Postintervention (0 and 6 months)
Assessed changes from Baseline Biological variables: Waist circunference at 12 months
Time Frame: Preintervention/Postintervention (0 and 12 months)
4. Waist circunference (cm)
Preintervention/Postintervention (0 and 12 months)
Assessed changes from Baseline Biological variables: Blood pressure at 6 months
Time Frame: Preintervention/Postintervention (0 and 6 months)
5. Systolic and diastolic Blood pressure (mmHg)
Preintervention/Postintervention (0 and 6 months)
Assessed changes from Baseline Biological variables: Blood pressure at 12 months
Time Frame: Preintervention/Postintervention (0 and 12 months)
5. Systolic and diastolic Blood pressure (mmHg)
Preintervention/Postintervention (0 and 12 months)
Assessed changes from Baseline Smoking and alcohol habits
Time Frame: Preintervention/Postintervention (0 and 6 months)
  1. Number of cigarettes per day
  2. Number of alcoholic drinks per day
Preintervention/Postintervention (0 and 6 months)
Assessed changes from Baseline Smoking and alcohol habits
Time Frame: Preintervention/Postintervention (0 and 12 months)
  1. Number of cigarettes per day
  2. Number of alcoholic drinks per day
Preintervention/Postintervention (0 and 12 months)
Evaluation of the change of baseline Health-related Quality of life at 6 months
Time Frame: Preintervention/Postintervention (0 and 6 months)
- Health-related quality of life: the EuroQol-5D-3L questionnaire validated in Spanish will be used, describing five dimensions (mobility, personal care, daily activities, pain/discomfort and anxiety/depression). It also consists of a visual analogue scale (VAS), graduated from 0 to 100 and labeled "worst imaginable health state" and "best imaginable health state", respectively.
Preintervention/Postintervention (0 and 6 months)
Evaluation of the change of baseline Health-related Quality of life at 12 months
Time Frame: Preintervention/Postintervention (0 and 12 months)
- Health-related quality of life: the EuroQol-5D-3L questionnaire validated in Spanish will be used, describing five dimensions (mobility, personal care, daily activities, pain/discomfort and anxiety/depression). It also consists of a visual analogue scale (VAS), graduated from 0 to 100 and labeled "worst imaginable health state" and "best imaginable health state", respectively.
Preintervention/Postintervention (0 and 12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: María Ángeles Vázquez Sanchez, PhD, Universidad de Málaga

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2022

Primary Completion (Actual)

September 1, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

February 9, 2022

First Submitted That Met QC Criteria

November 8, 2022

First Posted (Actual)

November 9, 2022

Study Record Updates

Last Update Posted (Actual)

December 2, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

February 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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