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

Official title

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

Overview

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.

Interventions

• Behavioral 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.
• Drug 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.
• Behavioral promoting healthy aging
  b) Non-pharmacological interventions, including nutritional guidance for a Mediterranean diet, dysphagia and cognitive impairment screening, and sleep hygiene counselling.
• Other against social isolation
  Support against social isolation by activating community resources.

Primary outcome measures

• Physical performance [Time frame: baseline, 3 months and 6 months]

Secondary outcome measures (6)

• Quality of life (QoL) [Time frame: baseline, 3 months and 6 months]
• Cognitive impairment [Time frame: baseline, 3 months and 6 months]
• Social engagement [Time frame: baseline, 3 months and 6 months]
• Adherence to the Mediterranean diet [Time frame: baseline, 3 months and 6 months]
• Adverse events [Time frame: baseline, 3 months and 6 months]
• The total number of medications [Time frame: baseline, 3 months and 6 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Sequential

Masking

Open label

Primary purpose

Treatment

Study locations

Spain · 3 centers

• Barceloneta - Primary Care Center — Barcelona
• Larrad - Primary Care Center — Barcelona
• Vila Olimpica - Primary Care Center — Barcelona

Publications

• 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
• 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
• 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
• 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 202 PMID 37064681
• 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

Identifiers

NCT: NCT06836167 · +AGIL Barcelona · BDNS 604045

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗