+AGIL Barcelona: Integrated Care for Community-Dwelling Frail Older Adults

Parc Sanitari Pere Virgili

Status: Enrolling

Conditions: Older Adults; Frailty; Healthy Aging

Treatments: Drug: review medication; Behavioral: promoting healthy aging; Other: against social isolation; Behavioral: exercise promotion

Study type: Interventional

Funder types: Other

Identifiers

NCT06836167

+AGIL Barcelona

BDNS 604045 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 396 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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396 participants in 2 patient groups

Control

No Intervention group

Description:

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.

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: exercise promotion

Other: against social isolation

Behavioral: promoting healthy aging

Drug: review medication