EMBRACE - From Vulnerable to Empowered: Implementation and Evaluation of a Multicomponent Program… (NCT07628686) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
EMBRACE - From Vulnerable to Empowered: Implementation and Evaluation of a Multicomponent Program to Tackling Age-related Decline
Portugal120 participantsStarted 2026-06-01
Plain-language summary
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.
Who can participate
Age range
60 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Montreal Cognitive Assessment (MoCA)
Timeframe: Baseline, post-intervention (12 months), and 6-month follow-up.
2
World Health Organization Quality of Life - Brief Version (WHOQOL-BREF)
Timeframe: Baseline, post-intervention (12 months), and 6-month follow-up.