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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 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

120

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Kombinationsprodukt: 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.
Kein Eingriff: Control Group
60 participants in the control group will not undergo the EMBRACE intervention; they will only receive regular health advice.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Montreal Cognitive Assessment (MoCA)
Zeitfenster: 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)
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
d2 Test
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University Fernando Pessoa

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juni 2026

Primärer Abschluss (Geschätzt)

31. Mai 2028

Studienabschluss (Geschätzt)

31. Mai 2029

Studienanmeldedaten

Zuerst eingereicht

12. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. Juni 2026

Zuerst gepostet (Tatsächlich)

5. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

5. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • COMPETE2030-FEDER-00892100

Plan für individuelle Teilnehmerdaten (IPD)

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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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