- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06733181
The REMINDER Program for Older Adults Supported by Residential and Daycare Facilities (REMINDER)
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
Conditions
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:
- 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Coimbra, Portugal, 3000-115
- Faculty of Psychology and Education Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
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
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:
|
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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