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

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.

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.

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.

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.

- Fried frailty criteria adapted to the Spanish population: subjects are considered non-frail when no criteria are present, pre-frail if they meet 1 or 2 of the criteria, and frail if they meet 3 to 5 criteria. Fried frailty criteria are divided into 5: Weight loss, Exhaustion, Physical Activity, Walking time, and Muscle weakness.

- Fried frailty criteria adapted to the Spanish population: subjects are considered non-frail when no criteria are present, pre-frail if they meet 1 or 2 of the criteria, and frail if they meet 3 to 5 criteria. Fried frailty criteria are divided into 5: Weight loss, Exhaustion, Physical Activity, Walking time, and Muscle weakness.

Unintentional weight loss of 5% or more in the last year: it is calculated using the difference between the current weight and that recorded in the medical record in the last year. If not available, the criterion is considered to be met if the answer is positive to Have you lost weight in the last year? and Have you lost more than 3 kg in the last year?

Unintentional weight loss of 5% or more in the last year: it is calculated using the difference between the current weight and that recorded in the medical record in the last year. If not available, the criterion is considered to be met if the answer is positive to Have you lost weight in the last year? and Have you lost more than 3 kg in the last year?

Self-reported exhaustion or tiredness: they met the criteria if they answered frequently or always in at least one of the 2 questions of the Center for Epidemiologic Studies Depression Scale (CES-D) questionnaire, do I feel that everything I do is an effort? And I don't feel like doing anything?

Self-reported exhaustion or tiredness: they met the criteria if they answered frequently or always in at least one of the 2 questions of the Center for Epidemiologic Studies Depression Scale (CES-D) questionnaire, do I feel that everything I do is an effort? And I don't feel like doing anything?

Based on the reduced version of the Minnesota Leisure Time Activity Questionnaire (VREM) validated in Spanish for this age group, which asks about leisure-time physical activity. The kilocalories (Kcal) per week expended are calculated using a standardized algorithm. This variable is stratified by gender. Men: those with <383 Kcals of physical activity per week meet the frailty criteria. Women: those with <270 Kcals per week meet the criteria for frailty.

Based on the reduced version of the Minnesota Leisure Time Activity Questionnaire (VREM) validated in Spanish for this age group, which asks about leisure-time physical activity. The kilocalories (Kcal) per week expended are calculated using a standardized algorithm. This variable is stratified by gender. Men: those with <383 Kcals of physical activity per week meet the frailty criteria. Women: those with <270 Kcals per week meet the criteria for frailty.

The results will be stratified by sex and height. Time limit to walk 4.57 meters for frailty, men taller than 1.63 cm: ≥6.4 seconds, all others: ≥7.2 seconds; women with a height over than 1.51 cm: ≥10.5 seconds, the rest: ≥11.2 seconds.

The results will be stratified by sex and height. Time limit to walk 4.57 meters for frailty, men taller than 1.63 cm: ≥6.4 seconds, all others: ≥7.2 seconds; women with a height over than 1.51 cm: ≥10.5 seconds, the rest: ≥11.2 seconds.

The grip strength in the dominant hand will be measured with an arch dynamometer (Jamar® digital hand dynamometer) that expresses the force in kilograms. Those who cannot perform the test or according to the cut-off values meet the criteria: body mass index (BMI) equal to or over than 30 (men ≤15 kg/cm2, women ≤7 kg/cm2); BMI between 25.1 and 29.9 (men ≤13 kg/cm2, women ≤6 kg/cm2), and BMI equal to or less than 25 (men ≤10 kg/cm2, women ≤6 kg/cm2).

The grip strength in the dominant hand will be measured with an arch dynamometer (Jamar® digital hand dynamometer) that expresses the force in kilograms. Those who cannot perform the test or according to the cut-off values meet the criteria: body mass index (BMI) equal to or over than 30 (men ≤15 kg/cm2, women ≤7 kg/cm2); BMI between 25.1 and 29.9 (men ≤13 kg/cm2, women ≤6 kg/cm2), and BMI equal to or less than 25 (men ≤10 kg/cm2, women ≤6 kg/cm2).

- 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

- 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

- 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.

- 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.

- 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.

- 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.

- 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.

- 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.

- 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.

- 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.

- Health-related quality of life: the EuroQol-5D-5L 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.

- Health-related quality of life: the EuroQol-5D-5L 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.

Evaluation of the change of baseline Functional capacity in daily life (Lawton & Brody scale and Barthel index) at 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.

Evaluation of the change of baseline Functional capacity in daily life (Lawton & Brody scale and Barthel index) at 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.

Evaluation of the change of baseline Functional capacity in daily life (Exercise, physical inactivity and sleep) at 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.

Evaluation of the change of baseline Functional capacity in daily life (Exercise, physical inactivity and sleep) at 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.

Evaluation of the change of baseline Functional capacity in daily life (Balance assessment) at 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.

Evaluation of the change of baseline Functional capacity in daily life (Balance assessment) at 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.

- 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.

- 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.

- 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.

- 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.

- 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.

- 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.

- 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.

- 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.

Number and type of chronic pathologies (comorbidities). Number of different medications you take daily and type of medication.

Number and type of chronic pathologies (comorbidities). Number of different medications you take daily and type of medication.

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 suffering from COPD stage III or IV; Patients suffering from unstable angina; Patients suffering from uncontrolled congestive heart failure, or unstable arrhythmia; Patients who cannot walk alone or with technical aids, such as bedridden people; patients in nursing home; Patients with cognitive impairment; Patients who do not understand Spanish; Patients with allergies to plastic or metal.