Clinical trial NCT06836167: +AGIL Barcelona: Integrated Care for Community-Dwelling Frail Older Adults
Official title: + AGIL Barcelona: Integrated Care for Community-Dwelling Frail Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Frailty
Older Adults
Healthy Aging
Keywords: frailty
older adults
Healthy Aging
integrated care
physical performance
intrinsic capacity
Lead sponsor: Parc Sanitari Pere Virgili
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 396
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped-Wedge Cluster Randomized Trial
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate the effectiveness of the +AGIL Barcelona program in helping older adults improve their physical abilities and delay disability. It will also explore how to adapt and expand the program to different neighborhoods in Barcelona. The main questions it aims to answer are:

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.

Detailed description: Population aging requires the implementation of sustained integrated strategies and programs to improve intrinsic capacity and delay disability in older adults. The +AGIL Barcelona program exemplifies a pragmatic, multicomponent intervention that effectively improves physical function by integrating health and community resources. This study aims to co-design, adapt, and scale up +AGIL to diverse socioeconomic areas in Barcelona, assessing its effectiveness and evaluating the process of progressive implementation.

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.

Eligibility criteria: Inclusion Criteria:

* People aged 65 or older
* Presenting with suggestive signs of frailty according to the Gérontopôle Frailty Screening Test (GFST).
* Agree to participate and sign informed consent

Exclusion Criteria:

* Requirement for hospital admission or an estimated life expectancy of less than one year.

Primary outcomes:
measure: Physical performance
timeFrame: baseline, 3 months and 6 months
Secondary outcomes:
measure: Quality of life (QoL)
timeFrame: baseline, 3 months and 6 months
measure: Cognitive impairment
timeFrame: baseline, 3 months and 6 months
measure: Social engagement
timeFrame: baseline, 3 months and 6 months
measure: Adherence to the Mediterranean diet
timeFrame: baseline, 3 months and 6 months
measure: Adverse events
timeFrame: baseline, 3 months and 6 months
measure: The total number of medications
timeFrame: baseline, 3 months and 6 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Barceloneta - Primary Care Center
city: Barcelona
country: Spain
facility: Larrad - Primary Care Center
city: Barcelona
country: Spain
facility: Vila Olimpica - Primary Care Center
Study officials:
affiliation: sbaro@perevirgili.cat
name: Sonia Baro, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.