The REMINDER4Care Program for Older Adults Supported by Residential and Daycare Facilities (REMINDER4Care)

April 27, 2026 updated by: Catarina Baptista, University of Coimbra

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Portugal
    • Portugal
      • Coimbra, Portugal, Portugal, 3000-115
        • Recruiting
        • Faculty of Psychology and Education Sciences
        • Contact:
        • Principal Investigator:
          • Catarina L. B. Baptista, PhD Student

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Aged 65 years and older
  • RDF users
  • Elementary reading and writing skills

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: REMINDER4Care intervention
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.
Other: REMINDER4Care

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.
No Intervention: Waiting-list group
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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.
Screening
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.
Screening and 1-week and 3-months post-intervention
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.
Screening and 1-week and 3-months post-intervention
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.
Baseline and 1-week and 3-months post-intervention
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.
Baseline and 1-week and 3-months post-intervention
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.
Baseline and 1-week and 3-months post-intervention
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.
Baseline and 1-week and 3-months post-intervention
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).
Baseline and 1-week and 3-months post-intervention
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.
Baseline and 1-week and 3-months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Coimbra

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fundação para a Ciência e a Tecnologia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Catarina L. B. Baptista, PhD Student, University of Coimbra
  • Study Chair: Ana Rita E. S. Silva, Doctorate, University of Coimbra
  • Study Chair: Margarida P. Lima, Doctorate, University of Coimbra
  • Study Chair: Rosa M. Afonso, Doctorate, University of Beira Interior

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RCTREMINDER4Care

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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