Aging, HealthyREMINDERNCT06733181
The REMINDER Program for Older Adults Supported by Residential and Daycare Facilities
A study testing REMINDER intervention in people with Aging, Healthy and Risk Reduction, run by University of Coimbra at 1 site in Portugal.
Trial summary
Dementia and mild cognitive impairment (MCI) deeply impact individuals' well-being and are expected to increase due to population aging, with global cases projected to rise to 152.8 million by 2050. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Healthy, Risk Reduction, Old Age; Dementia
- What is being tested?
- REMINDER intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 sitePortugal
- Study dates
- 20 Jul 2023to 26 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Individuals aged 65 years and older
- RDF users
- Those with elementary reading and writing skills.
Who cannot join
- Have a clinical diagnosis of dementia and/or 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 compromised their participation in the neuropsychological assessment and throughout the intervention sessions.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Faculty of Psychology and Education Sciences
Coimbra, Portugal, 3000-115
About this study
Official title: The REMINDER, a Multidomain Dementia Risk Reduction Program for Older Adults Supported by Residential Care Facilities: a Feasibility Study
Dementia and mild cognitive impairment (MCI) deeply impact individuals' well-being and are expected to increase due to population aging, with global cases projected to rise to 152.8 million by 2050. Social isolation, accounting for 4% of dementia cases, emerges as a critical modifiable risk factor, particularly in institutionalized older adults, where it significantly raises dementia risk.
To address these challenges, the REMINDER program was developed as a tailored, multidomain intervention to reduce dementia risk, emphasizing social and cognitive engagement and advancing its adaptation and evaluation in Residential and Daycare Facilities (RDF). To assess the feasibility of REMINDER in older adults supported by RDF (recruitment, adherence, retention, acceptability, accessibility, and usability) and explore potential changes in cognitive and psychosocial outcomes.
Read the detailed description
Implementing DRR programs in RDFs presents several unique challenges, including participant diversity in educational levels, physical and cognitive health, motivation, and logistical constraints within institutional settings. A feasibility study is essential to identify and determine how to overcome these barriers. Specifically, this study explores acceptability, accessibility, adherence, and usability to optimize the REMINDER intervention for RDF settings. By addressing these practical concerns, the feasibility trial will ensure the intervention is effective and implementable, laying the groundwork for a successful full-scale RCT that meets the needs of older adults in RDFs (resulting in an adapted version, the REMINDER4Care). By creating an engaging and well-accepted tool, we look forward to amplifying the RDF tools available to reduce the risk of dementia in their residents.
Objectives
The primary objectives of this study were as follows:
- To evaluate the acceptance rate of RDF and participants to join the research;
- To determine the suitability of participant eligibility criteria by estimating feasible eligibility and recruitment rates;
- To measure participant adherence and retention through attendance rates across all intervention sessions and trends over time;
- To assess the feasibility of the REMINDER program in clinical settings, including its acceptability, accessibility, and usability.
Secondary objectives included exploring preliminary changes in cognitive and psychosocial outcomes from baseline to post-intervention while acknowledging that the study was not powered to detect statistically significant effects.
- Conditions
- Aging, Healthy, Risk Reduction, Old Age; Dementia
- Being tested
- REMINDER intervention
- Keywords
- Dementia risk reduction, Older adults, Multidomain programs, Residential and Daycare Facilities, Social Isolation, Loneliness
- Medical subject headings
- Risk Reduction Behavior, Alzheimer Disease, Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REMINDER interventionOther
Also called REMINDER and my brain
The REMINDER 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). As for the structure of the sessions, each starts with a mindfulness exercise and concludes with a review of the homework assignments. Every session includes a psychoeducation component focused on a specific topic, a time for sharing and reflection, and a practical activity.
| Study group | Role | What they receive |
|---|---|---|
| REMINDER intervention | Experimental | The REMINDER 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). As for the structure of the sessions, each starts with a mindfulness exercise and concludes with a review of the homework assignments. Every session includes a psychoeducation component focused on a specific topic, a time for sharing and reflection, and a practical activity. Receives: Other: REMINDER intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility outcomes (quantitative)
Recruitment rate
Measured: During the intervention (at the end of the sessions) and 1-week after the intervention
Feasibility outcomes (quantitative)
Adherence
Measured: During the intervention (at the end of the sessions) and 1-week after the intervention
Feasibility outcomes (quantitative)
Retention
Measured: During the intervention (at the end of the sessions) and 1-week after the intervention
Feasibility outcomes (qualitative)
Acceptability (with Usefulness, Satisfaction, and Ease of use (USE) questionnaire) ranges from 7 to 49, with higher scores indicating greater acceptability.
Measured: During the intervention (at the end of the sessions) and 1-week after the intervention
Feasibility outcomes (qualitative)
Accessibility (with Usefulness, Satisfaction, and Ease of use (USE) questionnaire) ranges from 15 to 105, with higher scores indicating greater accessibility.
Measured: During the intervention (at the end of the sessions) and 1-week after the intervention
Feasibility outcomes (qualitative)
The intervention's usability (with Usefulness, Satisfaction, and Ease of use (USE) questionnaire) ranges from 8 to 56, with higher scores indicating greater usability.
Measured: During the intervention (at the end of the sessions) and 1-week after the intervention
Secondary outcomes (22)
Preliminary efficacy data (screening)
Participants' sociodemographic (age in years).
Measured: Screening
Preliminary efficacy data (screening)
Participants' sociodemographic (marital status).
Measured: Screening
Preliminary efficacy data (screening)
Participants' sociodemographic (education level).
Measured: Screening
Preliminary efficacy data (screening)
Participants' clinical information (presence of medical diagnosis).
Measured: Screening
Preliminary efficacy data (screening)
Participants' clinical information (current medication).
Measured: Screening
Preliminary efficacy data (screening)
Participants' clinical information (sensory issues).
Measured: Screening
Preliminary efficacy data (screening)
Participants' clinical information (mobility deficits).
Measured: Screening
Preliminary efficacy data (screening)
Participants' clinical information (substance use).
Measured: Screening
Preliminary efficacy data (screening)
Participants' clinical information (hospitalization).
Measured: Screening
Preliminary efficacy data (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
Preliminary efficacy data (screening)
Perceived Social Isolation: This was evaluated using the Questionnaire of Perceived Social Isolation (QPSI), which is scored on a scale of 1 to 5 per item, with higher scores indicating greater perceived social isolation.
Measured: Screening and 1-week post-intervention
Preliminary efficacy data (screening)
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 post-intervention
Preliminary efficacy data (Cognitive functions)
Episodic Memory: Measured with Word Lists I and II from the Wechsler Memory Scale-III (WMS-III), scored based on correct recalls, with higher scores reflecting better memory performance.
Measured: Baseline and 1-week post-intervention
Preliminary efficacy data (Cognitive functions)
Processing Speed: Evaluated with the Symbol Search subtest of the Wechsler Adult Intelligence Scale-III (WAIS-III), scored by correct responses within a time limit, with higher scores representing faster processing speed.
Measured: Baseline and 1-week post-intervention
Preliminary efficacy data (Cognitive functions)
Working Memory: Assessed with the Month Ordering task, scored by the number of correct sequences, where higher scores indicate better working memory.
Measured: Baseline and 1-week post-intervention
Preliminary efficacy data (Cognitive functions)
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 post-intervention
Preliminary efficacy data (Psychosocial/ Mental Health indicators)
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: Baseline and 1-week post-intervention
Preliminary efficacy data (Psychosocial/ Mental Health indicators)
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 post-intervention
Preliminary efficacy data (Psychosocial/ Mental Health indicators)
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 post-intervention
Preliminary efficacy data (Psychosocial/ Mental Health indicators)
Quality of Life: This is assessed using the World Health Organization Quality of Life (WHOQOL-BREF-7), scored on a scale of 1 to 5 for each item, with higher scores indicating better quality of life.
Measured: Baseline and 1-week post-intervention
Preliminary efficacy data (Psychosocial/ Mental Health indicators)
Life Satisfaction: This is measured using the Satisfaction with Life Scale (SWLS), scored from 5 to 25. Higher scores reflect greater life satisfaction.
Measured: Baseline and 1-week post-intervention
Preliminary efficacy data (Perceived and performance-based functional status)
Functional capacity: This is assessed using the UPSA-2-PT (UCSD Performance-Based Skills Assessment - 2nd version), scored from 0 to 100 points, with higher scores indicating better functionality.
Measured: Baseline and 1-week post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start20 Jul 2023
- Primary completion31 Jul 2024
- Study completion26 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aging, HealthyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catarina Baptista, University of Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06733181
- Sponsor's protocol ID
- FSREMINDERRDFIORG0011881
- Other IDs
- University of Coimbra
- Acronym
- REMINDER
- Status last verified
- Apr 2025
- First submitted
- 29 Nov 2024
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The REMINDER, a Multidomain Dementia Risk Reduction Program for Older Adults Supported by Residential Care Facilities: a Feasibility Study
- ClinicalTrials.gov ID
- NCT06733181
- Acronym / sponsor ID
- REMINDER / FSREMINDERRDFIORG0011881
- Conditions
- Aging, Healthy, Risk Reduction, Old Age; Dementia
- Keywords
- Dementia risk reduction, Older adults, Multidomain programs, Residential and Daycare Facilities, Social Isolation, Loneliness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 26 Oct 2024 (actual)
- First posted
- 13 Dec 2024 (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 and mild cognitive impairment (MCI) deeply impact individuals' well-being and are expected to increase due to population aging, with global cases projected to rise to 152.8 million by 2050. Social isolation, accounting for 4% of dementia cases, emerges as a critical modifiable risk factor, particularly in institutionalized older adults, where it significantly raises dementia risk.
To address these challenges, the REMINDER program was developed as a tailored, multidomain intervention to reduce dementia risk, emphasizing social and cognitive engagement and advancing its adaptation and evaluation in Residential and Daycare Facilities (RDF). To assess the feasibility of REMINDER in older adults supported by RDF (recruitment, adherence, retention, acceptability, accessibility, and usability) and explore potential changes in cognitive and psychosocial outcomes.
Detailed description
Implementing DRR programs in RDFs presents several unique challenges, including participant diversity in educational levels, physical and cognitive health, motivation, and logistical constraints within institutional settings. A feasibility study is essential to identify and determine how to overcome these barriers. Specifically, this study explores acceptability, accessibility, adherence, and usability to optimize the REMINDER intervention for RDF settings. By addressing these practical concerns, the feasibility trial will ensure the intervention is effective and implementable, laying the groundwork for a successful full-scale RCT that meets the needs of older adults in RDFs (resulting in an adapted version, the REMINDER4Care). By creating an engaging and well-accepted tool, we look forward to amplifying the RDF tools available to reduce the risk of dementia in their residents.
Objectives
The primary objectives of this study were as follows:
- To evaluate the acceptance rate of RDF and participants to join the research;
- To determine the suitability of participant eligibility criteria by estimating feasible eligibility and recruitment rates;
- To measure participant adherence and retention through attendance rates across all intervention sessions and trends over time;
- To assess the feasibility of the REMINDER program in clinical settings, including its acceptability, accessibility, and usability.
Secondary objectives included exploring preliminary changes in cognitive and psychosocial outcomes from baseline to post-intervention while acknowledging that the study was not powered to detect statistically significant effects.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| REMINDER intervention | Experimental | Other: REMINDER interventionThe REMINDER 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). As for the structure of the sessions, each starts with a mindfulness exercise and concludes with a review of the homework assignments. Every session includes a psychoeducation component focused on a specific topic, a time for sharing and reflection, and a practical activity. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Individuals aged 65 years and older
- RDF users
- Those with elementary reading and writing skills.
Key exclusion criteria (3 listed)
- Have a clinical diagnosis of dementia and/or 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 compromised 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 |
|---|---|---|
| REMINDER interventionAlso: REMINDER and my brainThe REMINDER 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). As for the structure of the sessions, each starts with a mindfulness exercise and concludes with a review of the homework assignments. Every session includes a psychoeducation component focused on a specific topic, a time for sharing and reflection, and a practical activity. | Other | REMINDER intervention |
Primary outcome
Feasibility outcomes (quantitative)
Time frame: During the intervention (at the end of the sessions) and 1-week after the intervention
Recruitment rate
Feasibility outcomes (quantitative)
Time frame: During the intervention (at the end of the sessions) and 1-week after the intervention
Adherence
Feasibility outcomes (quantitative)
Time frame: During the intervention (at the end of the sessions) and 1-week after the intervention
Retention
Feasibility outcomes (qualitative)
Time frame: During the intervention (at the end of the sessions) and 1-week after the intervention
Acceptability (with Usefulness, Satisfaction, and Ease of use (USE) questionnaire) ranges from 7 to 49, with higher scores indicating greater acceptability.
Feasibility outcomes (qualitative)
Time frame: During the intervention (at the end of the sessions) and 1-week after the intervention
Accessibility (with Usefulness, Satisfaction, and Ease of use (USE) questionnaire) ranges from 15 to 105, with higher scores indicating greater accessibility.
Feasibility outcomes (qualitative)
Time frame: During the intervention (at the end of the sessions) and 1-week after the intervention
The intervention's usability (with Usefulness, Satisfaction, and Ease of use (USE) questionnaire) ranges from 8 to 56, with higher scores indicating greater usability.
22 secondary outcomes
Preliminary efficacy data (screening)
Time frame: Screening
Preliminary efficacy data (screening)
Time frame: Screening
Preliminary efficacy data (screening)
Time frame: Screening
Preliminary efficacy data (screening)
Time frame: Screening
Preliminary efficacy data (screening)
Time frame: Screening
Preliminary efficacy data (screening)
Time frame: Screening
Preliminary efficacy data (screening)
Time frame: Screening
Preliminary efficacy data (screening)
Time frame: Screening
Preliminary efficacy data (screening)
Time frame: Screening
Preliminary efficacy data (screening)
Time frame: Screening
Preliminary efficacy data (screening)
Time frame: Screening and 1-week post-intervention
Preliminary efficacy data (screening)
Time frame: Screening and 1-week post-intervention
Preliminary efficacy data (Cognitive functions)
Time frame: Baseline and 1-week post-intervention
Preliminary efficacy data (Cognitive functions)
Time frame: Baseline and 1-week post-intervention
Preliminary efficacy data (Cognitive functions)
Time frame: Baseline and 1-week post-intervention
Preliminary efficacy data (Cognitive functions)
Time frame: Baseline and 1-week post-intervention
Preliminary efficacy data (Psychosocial/ Mental Health indicators)
Time frame: Baseline and 1-week post-intervention
Preliminary efficacy data (Psychosocial/ Mental Health indicators)
Time frame: Baseline and 1-week post-intervention
Preliminary efficacy data (Psychosocial/ Mental Health indicators)
Time frame: Baseline and 1-week post-intervention
Preliminary efficacy data (Psychosocial/ Mental Health indicators)
Time frame: Baseline and 1-week post-intervention
Preliminary efficacy data (Psychosocial/ Mental Health indicators)
Time frame: Baseline and 1-week post-intervention
Preliminary efficacy data (Perceived and performance-based functional status)
Time frame: Baseline and 1-week post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REMINDER intervention in people with Aging, Healthy and Risk Reduction, 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: finished, as of the sponsor's last update on 23 Apr 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility outcomes (quantitative) (time frame: During the intervention (at the end of the sessions) and 1-week after the intervention). The study lists 6 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 23 Apr 2025; AzTrials last refreshed its copy on 6 Nov 2026.