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

NCT06836167 | Recruiting

• 2 other identifiers: +AGIL BarcelonaBDNS 604045
• Study Type: interventional
• Target: 396
• Locations: 1 country
• Sites: 3

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.

Conditions

Frailty; Older Adults; Healthy Aging

Keywords

frailty; older adults; Healthy Aging; integrated care; physical performance; intrinsic capacity

Outcome Measures

Primary Outcomes (1)

• Physical performance

  measured using the Spanish-validated version of the Short Physical Performance Battery (SPPB). consistently with the previous demonstrator study, The SPPB includes sub-tests for balance, strength, and gait speed. Each sub-item is scored from 0 to 4 points, resulting in a maximum total score of 12, indicating optimal physical function. The SPPB is widely recognized as a predictor of disability in older adults. and serves as a primary indicator of frailty in this population. To assess the effectiveness of the +AGIL Barcelona program, we will use the total SPPB score and walking speed sub-item, which is also a strong predictor of adverse health outcomes in older populations. Scores range from 0 (worse) to 12 (maximum), values under 10 indicates frailty.

  baseline, 3 months and 6 months

Secondary Outcomes (6)

• Quality of life (QoL)

  baseline, 3 months and 6 months

• Cognitive impairment

  baseline, 3 months and 6 months

• Social engagement

  baseline, 3 months and 6 months

• Adherence to the Mediterranean diet

  baseline, 3 months and 6 months

• Adverse events

  baseline, 3 months and 6 months

Study Arms (2)

Control

NO INTERVENTION

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

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.

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

Interventions

exercise promotion BEHAVIORAL

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.

Intervention

review medication DRUG

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.

Also known as: person centered review medication

Intervention

promoting healthy aging BEHAVIORAL

b) Non-pharmacological interventions, including nutritional guidance for a Mediterranean diet, dysphagia and cognitive impairment screening, and sleep hygiene counselling.

Intervention

against social isolation OTHER

Support against social isolation by activating community resources.

Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Parc Sanitari Pere Virgili: lead

Study Sites (3)

Barceloneta - Primary Care Center

Barcelona, Spain

RECRUITING

Larrad - Primary Care Center

Barcelona, Spain

RECRUITING

Vila Olimpica - Primary Care Center

Barcelona, Spain

RECRUITING

Related Publications (5)

• 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.

  PMID: 30145055 BACKGROUND

• 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.

  PMID: 31560028 BACKGROUND

• 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.

  PMID: 37574781 BACKGROUND

• 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.

  PMID: 37064681 BACKGROUND

• 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.

  PMID: 37957601 BACKGROUND

MeSH Terms

Conditions

Frailty

Interventions

Medication Review

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Medication Systems; Organization and Administration; Health Services Administration; Patient Care Management

Study Officials

• Sonia Baro, MD

  sbaro@perevirgili.cat

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joan Sanabria

CONTACT

0034-932594000; jsanabria@perevirgili.cat

Aida Ribera, PhD

CONTACT

0034-932594000; ariberas@perevirgili.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stepped-Wedge Cluster Randomized Trial

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: February 20, 2025
• Study Start: November 2, 2022
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: February 20, 2025

Record last verified: 2025-01

Locations

ES (3)