- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05610605
Education for Prevention and Treatment of Frailty (FRAGSALUD)
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Cádiz
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Puerto Real, Cádiz, Spain, 11519
- Faculty of Education
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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 |
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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.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Evaluation of the Change of Baseline Fried Frailty Criteria at 6 Months
Time Frame: Preintervention/Postintervention (0 and 6 months)
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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)
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Evaluation of the Change of Baseline Fried Frailty Criteria at 12 Months
Time Frame: Preintervention/Retest (0 and 12 months)
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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)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Evaluation of the change of baseline Cognitive status at 6 months
Time Frame: Preintervention/Postintervention (0 and 6 months)
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- 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)
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Evaluation of the change of baseline Cognitive status at 12 months
Time Frame: Preintervention/Postintervention (0 and 12 months)
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- 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)
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Evaluation of the change of baseline Nutritional status at 6 months
Time Frame: Preintervention/Postintervention (0 and 6 months)
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- 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.
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Preintervention/Postintervention (0 and 6 months)
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Evaluation of the change of baseline Nutritional status at 12 months
Time Frame: Preintervention/Postintervention (0 and 12 months)
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- 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.
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Preintervention/Postintervention (0 and 12 months)
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Evaluation of the change of baseline Emotional state at 6 months
Time Frame: Preintervention/Postintervention (0 and 6 months)
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- 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.
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Preintervention/Postintervention (0 and 6 months)
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Evaluation of the change of baseline Emotional state at 12 months
Time Frame: Preintervention/Postintervention (0 and 12 months)
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- 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.
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Preintervention/Postintervention (0 and 12 months)
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Evaluation of the change of baseline Sleep quality at 6 months
Time Frame: Preintervention/Postintervention (0 and 6 months)
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- 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.
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Preintervention/Postintervention (0 and 6 months)
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Evaluation of the change of baseline Sleep quality at 12 months
Time Frame: Preintervention/Postintervention (0 and 12 months)
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- 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.
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Preintervention/Postintervention (0 and 12 months)
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Evaluation of the change of baseline Social interaction at 6 months
Time Frame: Preintervention/Postintervention (0 and 6 months)
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- 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.
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Preintervention/Postintervention (0 and 6 months)
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Evaluation of the change of baseline Social interaction at 12 months
Time Frame: Preintervention/Postintervention (0 and 12 months)
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- 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.
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Preintervention/Postintervention (0 and 12 months)
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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)
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- 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.
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Preintervention/Postintervention (0 and 6 months)
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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)
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- 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.
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Preintervention/Postintervention (0 and 12 months)
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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)
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- 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.
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Preintervention/Postintervention (0 and 6 months)
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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)
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- 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.
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Preintervention/Postintervention (0 and 12 months)
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Evaluation of the change of baseline Functional capacity in daily life (Balance assessment) at 6 months
Time Frame: Preintervention/Postintervention (0 and 6 months)
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- 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.
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Preintervention/Postintervention (0 and 6 months)
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Evaluation of the change of baseline Functional capacity in daily life (Balance assessment) at 12 months
Time Frame: Preintervention/Postintervention (0 and 12 months)
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- 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.
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Preintervention/Postintervention (0 and 12 months)
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Evaluation of the change of baseline Adverse outcomes at 6 months
Time Frame: Preintervention/Postintervention (0 and 6 months)
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- 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.
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Preintervention/Postintervention (0 and 6 months)
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Evaluation of the change of baseline Adverse outcomes at 12 months
Time Frame: Preintervention/Postintervention (0 and 12 months)
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- 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.
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Preintervention/Postintervention (0 and 12 months)
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Evaluation of the change of baseline self perceived confidence at 6 months
Time Frame: Preintervention/Postintervention (0 and 6 months)
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- 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.
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Preintervention/Postintervention (0 and 6 months)
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Evaluation of the change of baseline self perceived confidence at 12 months
Time Frame: Preintervention/Postintervention (0 and 12 months)
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- 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.
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Preintervention/Postintervention (0 and 12 months)
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Evaluation of the change of baseline Cost-utility analysis at 6 months
Time Frame: Preintervention/Postintervention (0 and 6 months)
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- 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)
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Evaluation of the change of baseline Cost-utility analysis at 12 months
Time Frame: Preintervention/Postintervention (0 and 12 months)
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- 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)
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Evaluation of the change of Intervention satisfaction assessed by CSQ-8 at 6 months
Time Frame: Preintervention/Postintervention (0 and 6 months)
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- 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.
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Preintervention/Postintervention (0 and 6 months)
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Evaluation of the change of Intervention satisfaction assessed by CSQ-8 at 12 months
Time Frame: Preintervention/Postintervention (0 and 12 months)
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- 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.
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Preintervention/Postintervention (0 and 12 months)
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Change in Sociodemographic data at 6 months
Time Frame: Preintervention/Postintervention (0 and 6 months)
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Date of birth, sex, marital status, cohabitation, educational level, amount of pension income.
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Preintervention/Postintervention (0 and 6 months)
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Change in Sociodemographic data at 12 months
Time Frame: Preintervention/Postintervention (0 and 12 months)
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Date of birth, sex, marital status, cohabitation, educational level, amount of pension income.
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Preintervention/Postintervention (0 and 12 months)
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Change in Medical data at 6 months
Time Frame: Preintervention/Postintervention (0 and 6 months)
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Number and type of chronic pathologies (comorbidities).
Number of different medications you take daily and type of medication.
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Preintervention/Postintervention (0 and 6 months)
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Change in Medical data at 12 months
Time Frame: Preintervention/Postintervention (0 and 12 months)
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Number and type of chronic pathologies (comorbidities).
Number of different medications you take daily and type of medication.
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Preintervention/Postintervention (0 and 12 months)
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Assessed changes from Baseline Blood Sample (Hematocrit) at 6 months
Time Frame: Preintervention/Postintervention (0 and 6 months)
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1. Hematocrit (%)
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Preintervention/Postintervention (0 and 6 months)
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Assessed changes from Baseline Blood Sample (Hematocrit) at 12months
Time Frame: Preintervention/Postintervention (0 and 12 months)
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1. Hematocrit (%)
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Preintervention/Postintervention (0 and 12 months)
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Assessed changes from Baseline Hemoglobin, protein and albumin sample at 6 months
Time Frame: Preintervention/Postintervention (0 and 6 months)
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2. Hemoglobin (g/dL) 3. Total protein (g/dL) 4. Serum Albumin (g/dL)
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Preintervention/Postintervention (0 and 6 months)
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Assessed changes from Baseline Hemoglobin, protein and albumin sample at 12 months
Time Frame: Preintervention/Postintervention (0 and 12 months)
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2. Hemoglobin (g/dL) 3. Total protein (g/dL) 4. Serum Albumin (g/dL)
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Preintervention/Postintervention (0 and 12 months)
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Assessed changes from Baseline lipids, and plasma creatinine sample at 6 months
Time Frame: Preintervention/Postintervention (0 and 6 months)
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5. Lipid profile (mg/dL) 6. Plasma creatinine (mg/dL)
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Preintervention/Postintervention (0 and 6 months)
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Assessed changes from Baseline lipids, and plasma creatinine sample at 12 months
Time Frame: Preintervention/Postintervention (0 and 12 months)
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5. Lipid profile (mg/dL) 6. Plasma creatinine (mg/dL)
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Preintervention/Postintervention (0 and 12 months)
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Assessed changes from Baseline Blood Sample (Glycosylated hemoglobin) at 6 months
Time Frame: Preintervention/Postintervention (0 and 6 months)
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7. Glycosylated hemoglobin (A1C)
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Preintervention/Postintervention (0 and 6 months)
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Assessed changes from Baseline Blood Sample (Glycosylated hemoglobin) at 12 months
Time Frame: Preintervention/Postintervention (0 and 12 months)
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7. Glycosylated hemoglobin (A1C)
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Preintervention/Postintervention (0 and 12 months)
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Assessed changes from Baseline Biological variables: Weight at 6 months
Time Frame: Preintervention/Postintervention (0 and 6 months)
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1. Weight (kilograms)
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Preintervention/Postintervention (0 and 6 months)
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Assessed changes from Baseline Biological variables: Weight at 12months
Time Frame: Preintervention/Postintervention (0 and 12 months)
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1. Weight (kilograms)
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Preintervention/Postintervention (0 and 12 months)
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Assessed changes from Baseline Biological variables: Height at 6 months
Time Frame: Preintervention/Postintervention (0 and 6 months)
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2. Height (meters)
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Preintervention/Postintervention (0 and 6 months)
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Assessed changes from Baseline Biological variables: Height at 12 months
Time Frame: Preintervention/Postintervention (0 and 12 months)
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2. Height (meters)
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Preintervention/Postintervention (0 and 12 months)
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Assessed changes from Baseline Biological variables: Body Mass Index at 6 months
Time Frame: Preintervention/Postintervention (0 and 6 months)
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3. Body Mass Index (kg/m^2)
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Preintervention/Postintervention (0 and 6 months)
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Assessed changes from Baseline Biological variables: Body Mass Index at 12 months
Time Frame: Preintervention/Postintervention (0 and 12 months)
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3. Body Mass Index (kg/m^2)
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Preintervention/Postintervention (0 and 12 months)
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Assessed changes from Baseline Biological variables: Waist circunference at 6 months
Time Frame: Preintervention/Postintervention (0 and 6 months)
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4. Waist circunference (cm)
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Preintervention/Postintervention (0 and 6 months)
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Assessed changes from Baseline Biological variables: Waist circunference at 12 months
Time Frame: Preintervention/Postintervention (0 and 12 months)
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4. Waist circunference (cm)
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Preintervention/Postintervention (0 and 12 months)
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Assessed changes from Baseline Biological variables: Blood pressure at 6 months
Time Frame: Preintervention/Postintervention (0 and 6 months)
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5. Systolic and diastolic Blood pressure (mmHg)
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Preintervention/Postintervention (0 and 6 months)
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Assessed changes from Baseline Biological variables: Blood pressure at 12 months
Time Frame: Preintervention/Postintervention (0 and 12 months)
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5. Systolic and diastolic Blood pressure (mmHg)
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Preintervention/Postintervention (0 and 12 months)
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Assessed changes from Baseline Smoking and alcohol habits
Time Frame: Preintervention/Postintervention (0 and 6 months)
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Preintervention/Postintervention (0 and 6 months)
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Assessed changes from Baseline Smoking and alcohol habits
Time Frame: Preintervention/Postintervention (0 and 12 months)
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Preintervention/Postintervention (0 and 12 months)
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Evaluation of the change of baseline Health-related Quality of life at 6 months
Time Frame: Preintervention/Postintervention (0 and 6 months)
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- 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.
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Preintervention/Postintervention (0 and 6 months)
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Evaluation of the change of baseline Health-related Quality of life at 12 months
Time Frame: Preintervention/Postintervention (0 and 12 months)
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- 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.
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Preintervention/Postintervention (0 and 12 months)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: María Ángeles Vázquez Sanchez, PhD, Universidad de Málaga
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FRAGSALUD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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