Dementia Risk FactorsREMINDER4CareNCT06922071
The REMINDER4Care Program for Older Adults Supported by Residential and Daycare Facilities
A study testing REMINDER4Care in people with Dementia Risk Factors and Prevention, run by University of Coimbra at 1 site in Portugal.
Trial summary
Dementia incidence is rising, posing a public health challenge, but 45% of cases can be prevented by addressing modifiable risk factors. Multidomain trials show that lifestyle changes can improve cognitive function and reduce dementia risk (like the FINGER trial). Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia Risk Factors, Prevention, Cognitive Health
- What is being tested?
- REMINDER4Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePortugal
- Study dates
- 1 May 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Aged 65 years and older
- RDF users
- Elementary reading and writing skills
Who cannot join
- Have a clinical diagnosis of dementia and/or Mini-Mental State Examination (MMSE) scores below the cutoff for the presence of dementia (MMSE < 22-27, depending on education level)
- Have a psychiatric or neurological condition that impairs cognition in the long term
- Have sensory and functional deficits that compromise their participation in the neuropsychological assessment and throughout the intervention sessions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
Faculty of Psychology and Education Sciences
Coimbra, Portugal, 3000-115
Catarina L. B. Baptista, PhD student, +351 963 031 318, catarinallbaptista23@gmail.com
Catarina L. B. Baptista, PhD Student
About this study
Dementia incidence is rising, posing a public health challenge, but 45% of cases can be prevented by addressing modifiable risk factors. Multidomain trials show that lifestyle changes can improve cognitive function and reduce dementia risk (like the FINGER trial). The REMINDER program, a Portuguese-based dementia risk reduction protocol, was developed for community-dwelling older adults aged 55 and above. However, older adults in Residential and Daycare Facilities (RDF) have distinct needs that demand program adaptation to ensure its relevance and effectiveness. In addition, more studies are needed to evaluate the impact of multidomain interventions with older adults in RDF.
To address these challenges, the REMINDER4Care program was developed as a tailored, multidomain intervention to reduce dementia risk. It emphasizes social and cognitive engagement and advances its adaptation and evaluation in Residential and Daycare Facilities (RDF). To assess efficacy, the investigators will perform a Randomized Controlled Trial.
- Conditions
- Dementia Risk Factors, Prevention, Cognitive Health
- Being tested
- REMINDER4Care
- Keywords
- Dementia Risk Factors, Prevention, Health, Aging, Residential and Daycare Facilities, Lifestyle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REMINDER4CareOther
REMINDER4Care was an adapted version of the original REMINDER program, tailored to the characteristics, needs, and interests of older adults in RDF.
The REMINDER4Care intervention includes 20 face-to-face group sessions, each approximately 60 to 75 minutes, held twice a week over ten weeks. This program aims to optimize memory, attention, executive function, and emotional regulation while promoting lifestyle habits that protect the aging brain. The sessions include brain health education, cognitive exercises, compensatory memory strategies, training for managing personally relevant goals (with goal setting), and stress management techniques (compassion-based therapies, relaxation methods, and mindfulness). Social support and emotion regulation strategies (like attention management, positive cognitive reappraisal, and reframing speech) were included to address psychosocial risk factors like stress, social isolation, and depression.
| Study group | Role | What they receive |
|---|---|---|
| REMINDER4Care intervention | Experimental | In this arm, participants will receive the intervention - REMINDER4Care. REMINDER4Care is a 20-session group program that includes psychoeducation about the brain, social skills training, using cognitive aids, setting personal goals, and practicing mindfulness. Receives: Other: REMINDER4Care |
| Waiting-list group | No intervention | In this arm, participants will be a waiting-list group and receive the REMINDER4Care interventions after the study ends (after the post-interventions). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening
Participants' sociodemographic (e.g., age, marital status, education level) and clinical (presence of medical diagnosis, current medication, sensory issues, mobility deficits, substance use, and hospitalization).
Measured: Screening
Screening
Dementia risk was assessed using the Lifestyle for BRAin health (LIBRA) score, which ranges from -2.1 to 10.6, with higher scores indicating a greater risk of developing dementia.
Measured: Screening
Cognitive status
Global cognition was assessed using Addenbrooke's Cognitive Examination - Revised (ACE-R), a scale with scores ranging from 0 to 100, where higher scores indicate better cognitive functioning.
Measured: Screening and 1-week and 3-months post-intervention
Mood status
Depressive Symptoms: Assessed using the Geriatric Depression Scale (GDS-30), a 30-item scale with scores ranging from 0 to 30, where higher scores indicate greater depressive symptoms.
Measured: Screening and 1-week and 3-months post-intervention
Cognitive status
Processing Speed: Evaluated with the Symbol Search subtest of the WAIS-III, scored by correct responses within a time limit, with higher scores representing faster processing speed.
Measured: Baseline and 1-week and 3-months post-intervention
Cognitive status
Verbal Initiative: Measured with the Verbal Fluency Test (letters M, R, and alternate category), scored by the number of correct words produced, with higher scores indicating greater verbal initiative.
Measured: Baseline and 1-week and 3-months post-intervention
Perceived social isolation and loneliness
Loneliness: Measured with the UCLA Loneliness Scale (UCLA LS-3), the score was 20 to 80, with higher scores reflecting greater perceived loneliness.
Measured: Baseline and 1-week and 3-months post-intervention
Perceived social network
Social Networks: Evaluated using Lubben's Brief Social Network Scale (LSNS-6), scored from 0 to 30, where higher scores indicate a stronger social network.
Measured: Baseline and 1-week and 3-months post-intervention
Functionality status
Functional abilities: This is measured using the IAFAI (Informant Assessment of Functioning in Aging and Intellectual Disabilities).
Measured: Baseline and 1-week and 3-months post-intervention
Perceived quality of life
Psychological Well-Being: Assessed using the EBEP-R is a short version of the Psychological Well-Being Scale. Higher scores on the EBEP-R indicate better psychological well-being.
Measured: Baseline and 1-week and 3-months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start1 May 2025
- Primary completion31 Jul 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia Risk FactorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia
- Responsible party
- Principal investigator, Catarina Baptista, University of Coimbra
- Investigators
- Catarina L. B. Baptista, PhD Student, Principal investigator, University of CoimbraAna Rita E. S. Silva, Doctorate, Study chair, University of CoimbraMargarida P. Lima, Doctorate, Study chair, University of CoimbraRosa M. Afonso, Doctorate, Study chair, University of Beira Interior
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922071
- Sponsor's protocol ID
- RCTREMINDER4Care
- Acronym
- REMINDER4Care
- Status last verified
- Apr 2025
- First submitted
- 31 Mar 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Open science plans will involve sharing IPD with other researchers, clearly anonymized, to promote the study's replication. The investigators are still developing the strategy for data sharing and will update as soon as it is defined.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The REMINDER4Care Program for Older Adults Supported by Residential and Daycare Facilities
- ClinicalTrials.gov ID
- NCT06922071
- Acronym / sponsor ID
- REMINDER4Care / RCTREMINDER4Care
- Conditions
- Dementia Risk Factors, Prevention, Cognitive Health
- Keywords
- Dementia Risk Factors, Prevention, Health, Aging, Residential and Daycare Facilities, Lifestyle
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dementia incidence is rising, posing a public health challenge, but 45% of cases can be prevented by addressing modifiable risk factors. Multidomain trials show that lifestyle changes can improve cognitive function and reduce dementia risk (like the FINGER trial). The REMINDER program, a Portuguese-based dementia risk reduction protocol, was developed for community-dwelling older adults aged 55 and above. However, older adults in Residential and Daycare Facilities (RDF) have distinct needs that demand program adaptation to ensure its relevance and effectiveness. In addition, more studies are needed to evaluate the impact of multidomain interventions with older adults in RDF.
To address these challenges, the REMINDER4Care program was developed as a tailored, multidomain intervention to reduce dementia risk. It emphasizes social and cognitive engagement and advances its adaptation and evaluation in Residential and Daycare Facilities (RDF). To assess efficacy, the investigators will perform a Randomized Controlled Trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REMINDER4Care intervention | Experimental | Other: REMINDER4CareIn this arm, participants will receive the intervention - REMINDER4Care. REMINDER4Care is a 20-session group program that includes psychoeducation about the brain, social skills training, using cognitive aids, setting personal goals, and practicing mindfulness. |
| Waiting-list group | No intervention | –In this arm, participants will be a waiting-list group and receive the REMINDER4Care interventions after the study ends (after the post-interventions). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Aged 65 years and older
- RDF users
- Elementary reading and writing skills
Key exclusion criteria (3 listed)
- Have a clinical diagnosis of dementia and/or Mini-Mental State Examination (MMSE) scores below the cutoff for the presence of dementia (MMSE < 22-27, depending on education level)
- Have a psychiatric or neurological condition that impairs cognition in the long term
- Have sensory and functional deficits that compromise their participation in the neuropsychological assessment and throughout the intervention sessions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REMINDER4CareREMINDER4Care was an adapted version of the original REMINDER program, tailored to the characteristics, needs, and interests of older adults in RDF. The REMINDER4Care intervention includes 20 face-to-face group sessions, each approximately 60 to 75 minutes, held twice a week over ten weeks. This program aims to optimize memory, attention, executive function, and emotional regulation while promoting lifestyle habits that protect the aging brain. The sessions include brain health education, cognitive exercises, compensatory memory strategies, training for managing personally relevant goals (with goal setting), and stress management techniques (compassion-based therapies, relaxation methods, and mindfulness). Social support and emotion regulation strategies (like attention management, positive cognitive reappraisal, and reframing speech) were included to address psychosocial risk factors like stress, social isolation, and depression. | Other | REMINDER4Care intervention |
Primary outcome
Screening
Time frame: Screening
Participants' sociodemographic (e.g., age, marital status, education level) and clinical (presence of medical diagnosis, current medication, sensory issues, mobility deficits, substance use, and hospitalization).
Screening
Time frame: Screening
Dementia risk was assessed using the Lifestyle for BRAin health (LIBRA) score, which ranges from -2.1 to 10.6, with higher scores indicating a greater risk of developing dementia.
Cognitive status
Time frame: Screening and 1-week and 3-months post-intervention
Global cognition was assessed using Addenbrooke's Cognitive Examination - Revised (ACE-R), a scale with scores ranging from 0 to 100, where higher scores indicate better cognitive functioning.
Mood status
Time frame: Screening and 1-week and 3-months post-intervention
Depressive Symptoms: Assessed using the Geriatric Depression Scale (GDS-30), a 30-item scale with scores ranging from 0 to 30, where higher scores indicate greater depressive symptoms.
Cognitive status
Time frame: Baseline and 1-week and 3-months post-intervention
Processing Speed: Evaluated with the Symbol Search subtest of the WAIS-III, scored by correct responses within a time limit, with higher scores representing faster processing speed.
Cognitive status
Time frame: Baseline and 1-week and 3-months post-intervention
Verbal Initiative: Measured with the Verbal Fluency Test (letters M, R, and alternate category), scored by the number of correct words produced, with higher scores indicating greater verbal initiative.
Perceived social isolation and loneliness
Time frame: Baseline and 1-week and 3-months post-intervention
Loneliness: Measured with the UCLA Loneliness Scale (UCLA LS-3), the score was 20 to 80, with higher scores reflecting greater perceived loneliness.
Perceived social network
Time frame: Baseline and 1-week and 3-months post-intervention
Social Networks: Evaluated using Lubben's Brief Social Network Scale (LSNS-6), scored from 0 to 30, where higher scores indicate a stronger social network.
Functionality status
Time frame: Baseline and 1-week and 3-months post-intervention
Functional abilities: This is measured using the IAFAI (Informant Assessment of Functioning in Aging and Intellectual Disabilities).
Perceived quality of life
Time frame: Baseline and 1-week and 3-months post-intervention
Psychological Well-Being: Assessed using the EBEP-R is a short version of the Psychological Well-Being Scale. Higher scores on the EBEP-R indicate better psychological well-being.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Undecided. Open science plans will involve sharing IPD with other researchers, clearly anonymized, to promote the study's replication. The investigators are still developing the strategy for data sharing and will update as soon as it is defined.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Catarina L. B. Baptista, PhD Student principal investigator
University of Coimbra
Ana Rita E. S. Silva, Doctorate study chair
University of Coimbra
Margarida P. Lima, Doctorate study chair
University of Coimbra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REMINDER4Care in people with Dementia Risk Factors and Prevention, run by University of Coimbra at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catarina L. B. Baptista, PhD Student (+351 963 031 318, catarinalbbaptista23@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening (time frame: Screening). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.