EMBRACE - From Vulnerable to Empowered: Implementation and Evaluation of a Multicomponent Program to Tackling Age-related Decline

Обзор

EMBRACE is a randomized, controlled, multi-domain, blinded clinical trial involving 120 community-dwelling older adults at risk of cognitive decline, lasting 12 months. Participants are randomized 1:1 to either a multicomponent intervention group, including cognitive and language training, physical activity, nutritional counseling with oral health support, and financial and digital literacy education, or to a control group receiving regular health counseling. The trial evaluates the effects of the intervention on cognitive performance, quality of life, functionality, financial literacy, digital inclusion, and other health-related outcomes.

Подробное описание

The EMBRACE program is a research initiative designed to address the increasing challenges of aging, particularly the risk of cognitive decline and dementia, vulnerability to economic fraud, and digital exclusion. The EMBRACE intervention is a multicomponent, non-pharmacological approach that includes cognitive training, linguistic stimulation, physical activity guidance, nutritional counseling, and education on financial and digital literacy. Through a carefully designed randomized controlled trial, this research project aims to evaluate the effectiveness of the EMBRACE program in improving the quality of life, functionality, and overall well-being of older adults.

By combining various aspects of health and well-being, the project aligns with the emphasis of the World Health Organization (WHO) on developing and implementing preventive strategies to reduce the risk of dementia. The innovative aspect of integrating financial and digital literacy education into the intervention recognizes the evolving challenges faced by the aging population, who are among the primary victims of economic fraud and particularly vulnerable to digital exclusion.

The primary beneficiaries of the EMBRACE program will be older adults who are at risk of developing cognitive decline or dementia. By equipping participants with tools and strategies to maintain cognitive health and physical well-being, the project aims to enhance quality of life. Moreover, the program's findings could inform public health policies and eldercare practices, potentially benefiting a broader spectrum of older adults by promoting strategies for active and healthy aging. In addition to direct participants, the project's outcomes are expected to benefit healthcare professionals, caregivers, and policymakers by providing validated approaches to prevent or delay cognitive decline among older adults. Furthermore, if the EMBRACE program proves successful, the investigators plan to integrate it into the curriculum of national senior universities and adapt it for digital platforms. This would enable global dissemination, extending its benefits to a broader audience worldwide.

Вмешательства

• Комбинированный продукт EMBRACE Intervention
  This intervention will last 12 months and will consist of four components. The nutritional intervention includes 5 individual sessions (at the beginning of the study and at 3, 6, 9, and 12 months) and 12 group sessions (1 per month) based on the Mediterranean diet, with support for oral health. Financial and digital literacy will be addressed in monthly sessions, covering topics such as retirement, investments, and fraud prevention. Cognitive and linguistic training will take place twice a week

Первичные конечные точки

• Montreal Cognitive Assessment (MoCA) [Срок оценки: Baseline, post-intervention (12 months), and 6-month follow-up.]
• World Health Organization Quality of Life - Brief Version (WHOQOL-BREF) [Срок оценки: Baseline, post-intervention (12 months), and 6-month follow-up.]

Вторичные конечные точки (12)

• d2 Test [Срок оценки: Baseline, post-intervention (12 months), and 6-month follow-up.]
• INECO Frontal Screening (IFS) [Срок оценки: Baseline, post-intervention (12 months), and 6-month follow-up.]
• Stroop Test [Срок оценки: Baseline, post-intervention (12 months), and 6-month follow-up.]
• Trail Making Test (TMT) [Срок оценки: Baseline, post-intervention (12 months), and 6-month follow-up.]
• Spatial Span Subtest of the Wechsler Memory Scale - Third Edition (WMS-III) [Срок оценки: Baseline, post-intervention (12 months), and 6-month follow-up.]
• Logical Memory Subtest of the Wechsler Memory Scale - Third Edition (WMS-III) [Срок оценки: Baseline, post-intervention (12 months), and 6-month follow-up.]
• Rey Auditory Verbal Learning Test (RAVLT) [Срок оценки: Baseline, post-intervention (12 months), and 6-month follow-up.]
• Boston Naming Test (BNT) [Срок оценки: Baseline, post-intervention (12 months), and 6-month follow-up.]
• Phonemic and Semantic Verbal Fluency Tests [Срок оценки: Baseline, post-intervention (12 months), and 6-month follow-up.]
• Instrumental Activities of Daily Living (IADL) [Срок оценки: Baseline, post-intervention (12 months), and 6-month follow-up.]
• Hospital Anxiety and Depression Scale (HADS) [Срок оценки: Baseline, post-intervention (12 months), and 6-month follow-up.]
• Numerical Activities of Daily Living - Financial (NADL-F) [Срок оценки: Baseline, post-intervention (12 months), and 6-month follow-up.]

Критерии участия

Критерии включения

• MoCA ≥ 17 (Portuguese cutoff point to differentiate between mild cognitive impairment and dementia);
• Bedside ≥ 20 for literate individuals or 12 for illiterate individuals.

Критерии исключения

• Malignant diseases;
• Diagnosed major depressive disorder;
• Dementia/substantial cognitive decline (MoCA < 17);
• Symptomatic cardiovascular disease;
• Revascularization within the last year;
• Active malignancy;
• Severe loss of vision, hearing, or communication;
• Contraindications for physical activity;
• Neuromuscular diseases;
• Severe musculoskeletal pathology;
• Inability to walk independently;
• Neurological disease affecting language functions;
• Simultaneous participation in any intervention trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Португалия · 1 центр

• University Fernando Pessoa — Porto

Публикации

• Vaz Serra et al. (2006). Estudos psicométricos do instrumento de avaliação da qualidade de vida da Organização Mundial de Saúde (WHOQOL-Bref) para português de Portugal. Psiquiatria Clínica, 27(1), 41-49
• Araújo et al. (2008). Validação da escala de Lawton e Brody numa amostra de idosos não institucionalizados. In I. Pais-Ribeiro et al. (Eds.), Actas do 7º Congresso Nacional de Psicologia da Saúde (pp. 217-220). ISPA.
• Cruz & Pais (2012). Cogweb-sistema integrado de estimulação cognitiva: Manual de formação para profissionais. Gaia: Neuroinova.
• Fernandes C, Pasion R, Goncalves AR, Ferreira-Santos F, Barbosa F, Martins IP, Marques-Teixeira J. Age differences in neural correlates of feedback processing after economic decisions under risk. Neurobiol Aging. 2018 May;65:51-59. doi: 10.1016/j.neurobiolaging.2018.01.003. Epub 2018 Jan 17. PMID 29407466
• Kibby MY, Schmitter-Edgecombe M, Long CJ. Ecological validity of neuropsychological tests: focus on the California Verbal Learning Test and the Wisconsin Card Sorting Test. Arch Clin Neuropsychol. 1998 Aug;13(6):523-34. PMID 14590636
• Williams, N. 2017. The Borg Rating of Perceived Exertion (RPE) scale. Occupational Medicine, 67 (5), 404-5.
• Tavares J, Faria A, Goncalves D, Mendes D, Silva S, Sousa L. Validation of the Portuguese version of the social isolation scale with a sample of community-dwelling older adults. Int J Nurs Sci. 2023 Mar 10;10(2):151-157. doi: 10.1016/j.ijnss.2023.03.002. eCollection 2023 Apr. PMID 37128493
• Wei, L., Peng, M., & Wu, W. 2021. Financial literacy and fraud detection--Evidence from China. International Review of Economics & Finance, 76, 478-94.

Идентификаторы

NCT: NCT07628686 · COMPETE2030-FEDER-00892100

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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