+AGIL Barcelona: Integrated Care for Community-Dwelling Frail Older Adults
NCT ID: NCT06836167
Last Updated: 2025-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
396 participants
INTERVENTIONAL
2022-11-02
2025-07-31
Brief Summary
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Does the +AGIL program improve physical abilities, as measured by a simple physical performance test (SPPB)? How well can the program be adapted and implemented in different community health centers? Researchers will conduct the study in three community health centers in Barcelona, following a stepped approach to gradually introduce the program at each site.
Participants will:
Participate in up to 10 weekly group exercise sessions led by a physiotherapist. Focus on strength, balance, flexibility, and endurance. Exercises will be tailored to individual needs and supported with easy-to-understand materials.
Receive advice on healthy habits like eating a Mediterranean diet, improving sleep, and managing swallowing or memory issues.
Get support to connect with local activities and resources to reduce loneliness and stay active, such as community centers or fitness programs.
Have their medications reviewed by healthcare professionals to ensure they are appropriate and safe.
The program will be personalized based on each participant's needs. This study will provide valuable information on implementing practical programs that help older adults stay healthy and independent.
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Detailed Description
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Methods: Multicenter, pragmatic, Stepped-Wedge Cluster Randomized Trial, performed in three Primary Care Centers in Barcelona (PCCs), involving older adults screened as frail by the Gérontopôle Frailty Screening Tool (total sample size=396, 198 per arm). After a co-design phase to adapt the protocol to each local context, the intervention will be introduced sequentially at each site, according to a randomly determined schedule, until all PCCs are exposed. The intervention, previously piloted in a different PCC, is based on a Comprehensive Geriatric Assessment followed by a 10-week tailored boost multicomponent intervention aligned with the Integrated Care for Older People (ICOPE) framework of the World Health Organization - WHO - (physical exercise being the core element). After three months, continuity of activation is pursued through the integration of community resources (public or private gyms, civic centers etc). The primary outcome will be. The investigators designed a mixed-methods evaluation, measuring physical performance improvement using the Short Physical Performance Battery (SPPB) as the primary quantitative outcome, plus a qualitative assessment of participants' experience and program implementation.
Discussion: This study will provide relevant information on the implementation and impact of pragmatic, real-life interventions to improve intrinsic capacity and prevent disability in older adults.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Control
During the adaptation phase of the program, all participating centers will begin by recruiting participants to the control group until they are transitioned to the recruitment of the intervention group. The control group will receive standard care plus educational materials focused on promoting a healthy lifestyle (videos or written materials, along with a weekly phone call to encourage viewing or address any questions). This is to avoid a bias related to the potential benefits of stricter follow-up in the intervention arm.
No interventions assigned to this group
Intervention
The +AGIL program aligns with the World Health Organization's framework for Integrated Care for Older People (Ferrara MC et al., J Intern Med. 2023). It includes:
1. Up to 10 weekly 1-hour group exercise sessions led by a physiotherapist, focusing on resistance, endurance, balance, and flexibility. Materials are adapted for low literacy or cognitive impairment, and Vivifrail® may be used to prevent frailty and falls.
2. Non-pharmacological measures, such as guidance on the Mediterranean diet, screening for swallowing difficulties and cognitive decline, and advice on improving sleep.
3. Support to reduce social isolation by connecting participants with community resources.
4. A medication review to optimize treatments and deprescribe unnecessary drugs. The program has demonstrated significant improvements in physical performance and intrinsic capacity at three and six months, maintained through empowerment and ongoing connection to community resources.
exercise promotion
a) Up to 10 weekly 1-hour group sessions of multicomponent exercise guided by a physiotherapist, incorporating resistance, endurance, balance, and flexibility. Supported by materials adapted for low literacy or cognitive impairment, it empowers participants to maintain physical activity. Vivifrail may be used to prevent frailty and falls.
review medication
d) Comprehensive medication review for optimization and deprescribing. Results show significant improvements in physical performance and intrinsic capacity at three and six months, sustained through empowerment and community resource connections.
promoting healthy aging
b) Non-pharmacological interventions, including nutritional guidance for a Mediterranean diet, dysphagia and cognitive impairment screening, and sleep hygiene counselling.
against social isolation
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Interventions
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exercise promotion
a) Up to 10 weekly 1-hour group sessions of multicomponent exercise guided by a physiotherapist, incorporating resistance, endurance, balance, and flexibility. Supported by materials adapted for low literacy or cognitive impairment, it empowers participants to maintain physical activity. Vivifrail may be used to prevent frailty and falls.
review medication
d) Comprehensive medication review for optimization and deprescribing. Results show significant improvements in physical performance and intrinsic capacity at three and six months, sustained through empowerment and community resource connections.
promoting healthy aging
b) Non-pharmacological interventions, including nutritional guidance for a Mediterranean diet, dysphagia and cognitive impairment screening, and sleep hygiene counselling.
against social isolation
Support against social isolation by activating community resources.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Presenting with suggestive signs of frailty according to the Gérontopôle Frailty Screening Test (GFST).
* Agree to participate and sign informed consent
Exclusion Criteria
65 Years
ALL
No
Sponsors
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Parc Sanitari Pere Virgili
OTHER
Responsible Party
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Principal Investigators
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Locations
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Barceloneta - Primary Care Center
Barcelona, , Spain
Larrad - Primary Care Center
Barcelona, , Spain
Vila Olimpica - Primary Care Center
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Inzitari M, Perez LM, Enfedaque MB, Soto L, Diaz F, Gual N, Martin E, Orfila F, Mulero P, Ruiz R, Cesari M. Integrated primary and geriatric care for frail older adults in the community: Implementation of a complex intervention into real life. Eur J Intern Med. 2018 Oct;56:57-63. doi: 10.1016/j.ejim.2018.07.022. Epub 2018 Aug 23.
Perez LM, Enfedaque-Montes MB, Cesari M, Soto-Bagaria L, Gual N, Burbano MP, Tarazona-Santabalbina FJ, Casas RM, Diaz F, Martin E, Gomez A, Orfila F, Inzitari M. A Community Program of Integrated Care for Frail Older Adults: +AGIL Barcelona. J Nutr Health Aging. 2019;23(8):710-716. doi: 10.1007/s12603-019-1244-4.
Ferrara MC, Perez LM, Sole AR, Villa-Garcia L, Ars J, Soto-Bagaria L, Bellelli G, Cesari M, Enfedaque MB, Inzitari M. Sustained improvement of intrinsic capacity in community-dwelling older adults: The +AGIL Barcelona multidomain program. J Intern Med. 2023 Dec;294(6):730-742. doi: 10.1111/joim.13710. Epub 2023 Aug 21.
Canet-Velez O, Solis-Navarro L, Sitja-Rabert M, Perez LM, Roca J, Soto-Bagaria L, Torres-Castro R, Diaz-Gallego F, Vilaro J, Inzitari M. Experience, facilitators, and barriers to the implementation of a multicomponent programme in older people living in the community, +AGIL Barcelona: A qualitative study. Front Public Health. 2023 Mar 30;11:1161883. doi: 10.3389/fpubh.2023.1161883. eCollection 2023.
Arnal C, Perez LM, Soto L, Herrero AC, Ars J, Baro S, Diaz F, Abilla A, Enfedaque MB, Cesari M, Inzitari M. Impact on physical function of the +AGIL Barcelona program in community-dwelling older adults with cognitive impairment: an interventional cohort study. BMC Geriatr. 2023 Nov 13;23(1):736. doi: 10.1186/s12877-023-04292-4.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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BDNS 604045
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
+AGIL Barcelona
Identifier Type: -
Identifier Source: org_study_id
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