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

2 juni 2026 bijgewerkt door: Carina Fernandes, University Fernando Pessoa
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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

120

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Portugal
    • Porto District
      • Porto, Porto District, Portugal, 4249-004

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Experimental Group
60 participants in the experimental group (EG) will receive an intensive multicomponent intervention consisting of nutrition and oral medicine; physical activity; cognitive training (or compensation in those cases in which participants revealed mild cognitive impairment at the baseline assessment); and financial and digital literacy education.
Combinatie product: 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 (80 sessions), with activities adapted through the COGWEB platform and support from a speech therapist. Physical training will also be conducted twice a week, including aerobic exercise, strength training, balance training, and dual-task training, with intensity adjusted using the Borg scale.
Geen tussenkomst: Control Group
60 participants in the control group will not undergo the EMBRACE intervention; they will only receive regular health advice.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Montreal Cognitive Assessment (MoCA)
Tijdsspanne: Baseline, post-intervention (12 months), and 6-month follow-up.
General cognitive functions will be assessed using the MoCA. The MoCA is a cognitive screening instrument used to evaluate multiple cognitive domains, with scores ranging from 0 to 30, where higher scores indicate better cognitive performance.
Baseline, post-intervention (12 months), and 6-month follow-up.
World Health Organization Quality of Life - Brief Version (WHOQOL-BREF)
Tijdsspanne: Baseline, post-intervention (12 months), and 6-month follow-up.
Quality of life will be assessed using the WHOQOL-BREF. The WHOQOL-BREF is a questionnaire used to evaluate quality of life across physical, psychological, social relationships, and environmental domains, with scores ranging from 0 to 100, where higher scores indicate better quality of life.
Baseline, post-intervention (12 months), and 6-month follow-up.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
d2 Test
Tijdsspanne: Baseline, post-intervention (12 months), and 6-month follow-up.
Selective attention and concentration ability will be assessed using the d2 Test. The d2 Test is a neuropsychological instrument used to evaluate selective attention, concentration, and processing speed through a timed cancellation task consisting of 14 lines to be completed in a maximum of 20 seconds per line. Performance is measured through task execution indices, concentration, processing speed, and error percentage. Higher scores on task execution and concentration indices, and lower error percentages, indicate better attentional performance.
Baseline, post-intervention (12 months), and 6-month follow-up.
INECO Frontal Screening (IFS)
Tijdsspanne: Baseline, post-intervention (12 months), and 6-month follow-up.
Executive functions will be assessed using the IFS. The IFS is a cognitive screening instrument used to evaluate executive functioning, including inhibitory control, cognitive flexibility, working memory, and abstraction ability, with scores ranging from 0 to 30, where higher scores indicate better executive functioning.
Baseline, post-intervention (12 months), and 6-month follow-up.
Stroop Test
Tijdsspanne: Baseline, post-intervention (12 months), and 6-month follow-up.
Inhibitory control, cognitive flexibility, and resistance to interference will be assessed using the Stroop Test. The Stroop Test consists of three tasks (word, color, and color-word), each administered within a maximum time of 45 seconds. Performance is measured by the number of words, colors, and stimuli correctly identified, where higher scores indicate better cognitive performance.
Baseline, post-intervention (12 months), and 6-month follow-up.
Trail Making Test (TMT)
Tijdsspanne: Baseline, post-intervention (12 months), and 6-month follow-up.
Alternating attention, visual attention, and processing speed will be assessed using the TMT. The TMT is a neuropsychological instrument used to evaluate visual attention, alternating attention, and processing speed through a timed task requiring participants to connect a sequence of numbers and letters. Performance is measured by completion time in seconds, where shorter completion times indicate better cognitive performance.
Baseline, post-intervention (12 months), and 6-month follow-up.
Spatial Span Subtest of the Wechsler Memory Scale - Third Edition (WMS-III)
Tijdsspanne: Baseline, post-intervention (12 months), and 6-month follow-up.
Working memory will be assessed using the Spatial Span Subtest of the WMS-III. The Spatial Span Subtest is a neuropsychological instrument used to evaluate visuospatial working memory through forward and backward span tasks, with scores ranging from 0 to 32, where higher scores indicate better working memory performance.
Baseline, post-intervention (12 months), and 6-month follow-up.
Logical Memory Subtest of the Wechsler Memory Scale - Third Edition (WMS-III)
Tijdsspanne: Baseline, post-intervention (12 months), and 6-month follow-up.
Immediate and delayed verbal episodic memory will be assessed using the Logical Memory Subtest of the WMS-III. The Logical Memory Subtest is a neuropsychological instrument used to evaluate the recall and recognition of verbally presented information, with scores ranging from 0 to 75 for immediate recall, 0 to 30 for delayed recall, and 0 to 30 for recognition, where higher scores indicate better memory performance.
Baseline, post-intervention (12 months), and 6-month follow-up.
Rey Auditory Verbal Learning Test (RAVLT)
Tijdsspanne: Baseline, post-intervention (12 months), and 6-month follow-up.
Verbal learning and memory will be assessed using the RAVLT. The RAVLT is a neuropsychological instrument used to evaluate verbal learning, immediate recall, delayed recall, and recognition memory through repeated presentation of a 15-word list. Performance is measured by the number of correctly recalled or recognized words across the assessment trials, where higher scores indicate better verbal learning and memory performance.
Baseline, post-intervention (12 months), and 6-month follow-up.
Boston Naming Test (BNT)
Tijdsspanne: Baseline, post-intervention (12 months), and 6-month follow-up.
Naming ability will be assessed using the BNT. The BNT is a neuropsychological instrument used to evaluate confrontation naming ability through the identification of visually presented objects, with scores ranging from 0 to 60, where higher scores indicate better naming performance.
Baseline, post-intervention (12 months), and 6-month follow-up.
Phonemic and Semantic Verbal Fluency Tests
Tijdsspanne: Baseline, post-intervention (12 months), and 6-month follow-up.
Verbal fluency and executive functions will be assessed through Phonemic and Semantic Verbal Fluency Tests. These neuropsychological tests are used to evaluate information retrieval from memory, executive functions (such as cognitive flexibility, planning, and inhibitory control), and language production through word generation within a maximum time frame of 1 minute for each task, where higher scores indicate better performance in verbal fluency.
Baseline, post-intervention (12 months), and 6-month follow-up.
Instrumental Activities of Daily Living (IADL)
Tijdsspanne: Baseline, post-intervention (12 months), and 6-month follow-up.
Functionality in instrumental activities of daily living will be assessed using the IADL scale. The IADL scale is used to evaluate independence in everyday functional activities, with scores ranging from 8 to 31, where lower scores indicate greater functional independence.
Baseline, post-intervention (12 months), and 6-month follow-up.
Hospital Anxiety and Depression Scale (HADS)
Tijdsspanne: Baseline, post-intervention (12 months), and 6-month follow-up.
Symptoms of anxiety and depression will be assessed using the HADS. The HADS is a self-report questionnaire used to evaluate symptoms of anxiety and depression, with scores ranging from 0 to 21 for each subscale, where higher scores indicate greater symptom severity.
Baseline, post-intervention (12 months), and 6-month follow-up.
Numerical Activities of Daily Living - Financial (NADL-F)
Tijdsspanne: Baseline, post-intervention (12 months), and 6-month follow-up.
Financial literacy and functionality in numerical activities of daily living will be assessed using the NADL-F assessment. The NADL-F is used to evaluate financial abilities and numerical functioning in everyday activities across domains including money counting (scores ranging from 0 to 5), reading abilities (0 to 8), purchasing articles (0 to 14), percentages (0 to 9), financial concepts (0 to 14), bill payment (0 to 6), and financial judgment (0 to 6), where higher scores indicate better financial functioning and autonomy in daily life.
Baseline, post-intervention (12 months), and 6-month follow-up.
Bedside Language Test
Tijdsspanne: Baseline, post-intervention (12 months), and 6-month follow-up.
Language abilities will be assessed using the Bedside Language Test. The Bedside Language Test is a language assessment tool used to evaluate speech, language comprehension, repetition, reading, and writing abilities, with scores ranging from 0 to 25, where higher scores indicate better language performance.
Baseline, post-intervention (12 months), and 6-month follow-up.
PREDIMED
Tijdsspanne: Baseline, post-intervention (12 months), and 6-month follow-up.
Adherence to the Mediterranean diet will be assessed using the PREDIMED questionnaire. The PREDIMED questionnaire is used to evaluate adherence to Mediterranean dietary patterns, with scores ranging from 0 to 14, where higher scores indicate greater adherence to the Mediterranean diet.
Baseline, post-intervention (12 months), and 6-month follow-up.
International Physical Activity Questionnaire (IPAQ)
Tijdsspanne: Baseline, post-intervention (12 months), and 6-month follow-up.
Physical activity level will be assessed using the IPAQ. The IPAQ is used to evaluate the frequency, duration, and intensity of physical activity performed in daily life. Physical activity levels are calculated in MET-minutes per week based on the frequency and duration of walking and moderate- and vigorous-intensity activities, with higher scores indicating higher levels of physical activity.
Baseline, post-intervention (12 months), and 6-month follow-up.
Timed Up and Go Test (TUG)
Tijdsspanne: Baseline, post-intervention (12 months), and 6-month follow-up.
Functional mobility and dynamic balance ability will be assessed using the TUG. The TUG is used to evaluate functional mobility and dynamic balance through the time required to stand up from a chair, walk a short distance, return, and sit down, with performance measured in seconds, where shorter completion times indicate better functional mobility and balance.
Baseline, post-intervention (12 months), and 6-month follow-up.
Blood Pressure
Tijdsspanne: Baseline, post-intervention (12 months), and 6-month follow-up
Systolic and diastolic blood pressure will be measured in millimeters of mercury (mmHg). Scores range from approximately (for diastolic) 60-120 and (for systolic) 100-180 mmHg, with higher scores indicating higher blood pressure.
Baseline, post-intervention (12 months), and 6-month follow-up
Body Mass Index (BMI)
Tijdsspanne: Baseline, post-intervention (12 months), and 6-month follow-up
Body mass index (BMI) will be calculated using body weight and height and expressed in kilograms per square meter (kg/m²). BMI is a measure of body size based on weight relative to height.
Baseline, post-intervention (12 months), and 6-month follow-up
Handgrip Strength
Tijdsspanne: Baseline, post-intervention (12 months), and 6-month follow-up
Handgrip strength will be assessed using a hand dynamometer. Performance is measured in kilograms-force (kgf), where higher values indicate greater muscular strength.
Baseline, post-intervention (12 months), and 6-month follow-up
Blood Count
Tijdsspanne: Baseline, post-intervention (12 months), and 6-month follow-up
Hematological status will be assessed using a blood count performed through blood analysis. Results will be reported according to standard laboratory reference units.
Baseline, post-intervention (12 months), and 6-month follow-up
Serum Magnesium
Tijdsspanne: Baseline, post-intervention (12 months), and 6-month follow-up
Serum magnesium levels will be assessed through blood analysis and reported according to standard laboratory reference units.
Baseline, post-intervention (12 months), and 6-month follow-up
Serum Iron
Tijdsspanne: Baseline, post-intervention (12 months), and 6-month follow-up
Serum iron levels will be assessed through blood analysis and reported according to standard laboratory reference units.
Baseline, post-intervention (12 months), and 6-month follow-up
Vitamin B12
Tijdsspanne: Baseline, post-intervention (12 months), and 6-month follow-up
Vitamin B12 levels will be assessed through blood analysis and reported according to standard laboratory reference units.
Baseline, post-intervention (12 months), and 6-month follow-up
Decayed, Missing, and Filled Teeth Index (CPO-D)
Tijdsspanne: Baseline, post-intervention (12 months), and 6-month follow-up.
Oral health status will be assessed using the Decayed, Missing, and Filled Teeth Index (CPO-D). The CPO-D index is used to evaluate oral health status based on the number of decayed, missing, and filled teeth, where higher scores indicate poorer oral health status.
Baseline, post-intervention (12 months), and 6-month follow-up.
Salivary pH Analysis
Tijdsspanne: Baseline, post-intervention (12 months), and 6-month follow-up.
Salivary condition and oral health status will be assessed using salivary pH analysis. Salivary pH values will be measured to evaluate salivary condition and oral health status, and will be reported according to standard pH units.
Baseline, post-intervention (12 months), and 6-month follow-up.
Dental Prosthesis Status
Tijdsspanne: Baseline, post-intervention (12 months), and 6-month follow-up.
Dental prosthesis status will be assessed through clinical oral examination. The assessment will evaluate the presence, type, functional status, and need for adjustment or replacement of dental prostheses.
Baseline, post-intervention (12 months), and 6-month follow-up.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University Fernando Pessoa

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juni 2026

Primaire voltooiing (Geschat)

31 mei 2028

Studie voltooiing (Geschat)

31 mei 2029

Studieregistratiedata

Eerst ingediend

12 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

2 juni 2026

Eerst geplaatst (Werkelijk)

5 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

2 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • COMPETE2030-FEDER-00892100

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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