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| Name | Class |
|---|---|
| University of Malaga | OTHER |
| Instituto de investigación e innovación biomédica de Cádiz | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | 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. | |
| Intervention Group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health intervention programme: FRAGSALUD | Other | The FRAGSALUD Program consists in two parts, a first part of health education that will be taught in a group in four sessions, and a second part of individual treatment and follow-up, individual consultations will have a bimonthly periodicity until reaching one year, at which time that the program ends and a final evaluation will be carried out to assess whether the changes are maintained 15 months after the start. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the Change of Baseline Fried Frailty Criteria at 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 | 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| María Ángeles Vázquez Sanchez, PhD | Universidad de Málaga | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Education | Puerto Real | Cádiz | 11519 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40121126 | Derived | Costilla M, Corral-Perez J, Vazquez-Sanchez MA, Avila-Cabeza-de-Vaca L, Gonzalez-Mariscal A, Casals C. Improvements in Depressive Symptoms, Perceived Social Support, and Quality of Life Through an Educational Program in Community-Dwelling Older Adults With Frailty Phenotype: A Randomized Controlled Trial of the FRAGSALUD Project. Am J Geriatr Psychiatry. 2025 Aug;33(8):877-890. doi: 10.1016/j.jagp.2025.02.014. Epub 2025 Mar 1. | |
| 39579605 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. Health intervention programme: FRAGSALUD: 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6-month Assessment |
|
| |||||||||||||||||||||
| 12-month Assessment |
|
The study enrolled individuals residing in the community across Cadiz and Malaga pronvices. To meet the criteria for participation, individuals needed to be aged 65 years or above, display at least one aspect of Fried's frailty phenotype and being in full possession of their faculties to voluntarily participate in the study. Those ineligible for participation encompassed individuals in institutional settings, and individuals categorized as robust (without any Fried's frailty criteria).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Evaluation of the Change of Baseline Fried Frailty Criteria at 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 | Older adults (>65 years) with frailty phenotype | Posted | Mean | Standard Deviation | scores on a scale | Preintervention/Postintervention (0 and 6 months) |
|
The data was obtained at the end of the intervention (6 months) and 6 months after the completion of the intervention (12 months)
Adverse events were systematically assessed by study personnel at the 6-month and 12-month follow-up visits. All-cause mortality was tracked for all participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cristina Casals | University of Cadiz | 956016216 | cristina.casals@uca.es |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 24, 2025 | Sep 24, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000073496 | Frailty |
| D006266 | Health Education |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000099060 | Adherence Interventions |
| D055118 | Medication Adherence |
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|
| Derived |
| 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. |
| 39002328 | Derived | 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. |
| 38470426 | Derived | 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. |
| 38038169 | Derived | 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. |
| Institutionalized |
|
| NOT COMPLETED |
|
|
| 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. Health intervention programme: FRAGSALUD: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Fried's Frailty Criteria | 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 | Mean | Standard Deviation | scores on a scale |
|
| OG001 | 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. Health intervention programme: FRAGSALUD: The FRAGSALUD Program consists in two parts, a first part of health education that will be taught in a group in four sessions, and a second part of individual treatment and follow-up, individual consultations will have a bimonthly periodicity until reaching one year, at which time that the program ends and a final evaluation will be carried out to assess whether the changes are maintained 15 months after the start. |
|
|
| Primary | Evaluation of the Change of Baseline Fried Frailty Criteria at 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 | Older adults (>65 years) with frailty phenotype. | Posted | Mean | Standard Deviation | scores on a scale | Preintervention/Retest (0 and 12 months) |
|
|
|
| 3 |
| 117 |
| 0 |
| 117 |
| 0 |
| 117 |
| EG001 | 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. Health intervention programme: FRAGSALUD: 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. | 2 | 118 | 0 | 118 | 0 | 118 |
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| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |