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

April 17, 2025 updated by: Catarina Baptista, University of Coimbra

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.

Study Overview

Status

Completed

Intervention / Treatment

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:

  1. To evaluate the acceptance rate of RDF and participants to join the research;
  2. To determine the suitability of participant eligibility criteria by estimating feasible eligibility and recruitment rates;
  3. To measure participant adherence and retention through attendance rates across all intervention sessions and trends over time;
  4. 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 Type

Interventional

Enrollment (Actual)

25

Phase

  • 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 Locations

      • Coimbra, Portugal, 3000-115
        • Faculty of Psychology and Education Sciences

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

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Individuals aged 65 years and older
  • RDF users
  • Those with elementary reading and writing skills.

Exclusion Criteria:

  • 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.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: REMINDER intervention
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.
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.
Other Names:
  • REMINDER and my brain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility outcomes (quantitative)
Time Frame: During the intervention (at the end of the sessions) and 1-week after the intervention
Recruitment rate
During the intervention (at the end of the sessions) and 1-week after the intervention
Feasibility outcomes (quantitative)
Time Frame: During the intervention (at the end of the sessions) and 1-week after the intervention
Adherence
During the intervention (at the end of the sessions) and 1-week after the intervention
Feasibility outcomes (quantitative)
Time Frame: During the intervention (at the end of the sessions) and 1-week after the intervention
Retention
During the intervention (at the end of the sessions) and 1-week after the intervention
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.
During the intervention (at the end of the sessions) and 1-week after the intervention
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.
During the intervention (at the end of the sessions) and 1-week after the intervention
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.
During the intervention (at the end of the sessions) and 1-week after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preliminary efficacy data (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
Preliminary efficacy data (screening)
Time Frame: Screening and 1-week 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 post-intervention
Preliminary efficacy data (screening)
Time Frame: Screening and 1-week post-intervention
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.
Screening and 1-week post-intervention
Preliminary efficacy data (Cognitive functions)
Time Frame: Baseline and 1-week post-intervention
Working Memory: Assessed with the Month Ordering task, scored by the number of correct sequences, where higher scores indicate better working memory.
Baseline and 1-week post-intervention
Preliminary efficacy data (Cognitive functions)
Time Frame: Baseline and 1-week 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 post-intervention
Preliminary efficacy data (Psychosocial/ Mental Health indicators)
Time Frame: Baseline and 1-week 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.
Baseline and 1-week post-intervention
Preliminary efficacy data (Psychosocial/ Mental Health indicators)
Time Frame: Baseline and 1-week 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 post-intervention
Preliminary efficacy data (Psychosocial/ Mental Health indicators)
Time Frame: Baseline and 1-week 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 post-intervention
Preliminary efficacy data (Psychosocial/ Mental Health indicators)
Time Frame: Baseline and 1-week post-intervention
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.
Baseline and 1-week post-intervention
Preliminary efficacy data (Psychosocial/ Mental Health indicators)
Time Frame: Baseline and 1-week post-intervention
Life Satisfaction: This is measured using the Satisfaction with Life Scale (SWLS), scored from 5 to 25. Higher scores reflect greater life satisfaction.
Baseline and 1-week post-intervention
Preliminary efficacy data (screening)
Time Frame: Screening
Participants' sociodemographic (age in years).
Screening
Preliminary efficacy data (screening)
Time Frame: Screening
Participants' sociodemographic (marital status).
Screening
Preliminary efficacy data (screening)
Time Frame: Screening
Participants' sociodemographic (education level).
Screening
Preliminary efficacy data (screening)
Time Frame: Screening
Participants' clinical information (presence of medical diagnosis).
Screening
Preliminary efficacy data (screening)
Time Frame: Screening
Participants' clinical information (current medication).
Screening
Preliminary efficacy data (screening)
Time Frame: Screening
Participants' clinical information (sensory issues).
Screening
Preliminary efficacy data (screening)
Time Frame: Screening
Participants' clinical information (mobility deficits).
Screening
Preliminary efficacy data (screening)
Time Frame: Screening
Participants' clinical information (substance use).
Screening
Preliminary efficacy data (screening)
Time Frame: Screening
Participants' clinical information (hospitalization).
Screening
Preliminary efficacy data (Cognitive functions)
Time Frame: Baseline and 1-week post-intervention
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.
Baseline and 1-week post-intervention
Preliminary efficacy data (Cognitive functions)
Time Frame: Baseline and 1-week post-intervention
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.
Baseline and 1-week post-intervention
Preliminary efficacy data (Perceived and performance-based functional status)
Time Frame: Baseline and 1-week post-intervention
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.
Baseline and 1-week post-intervention

Collaborators and Investigators

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

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)

July 20, 2023

Primary Completion (Actual)

July 31, 2024

Study Completion (Actual)

October 26, 2024

Study Registration Dates

First Submitted

November 29, 2024

First Submitted That Met QC Criteria

December 9, 2024

First Posted (Actual)

December 13, 2024

Study Record Updates

Last Update Posted (Actual)

April 23, 2025

Last Update Submitted That Met QC Criteria

April 17, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • FSREMINDERRDFIORG0011881
  • University of Coimbra (Other Identifier: University of Coimbra)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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