- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06922071
The REMINDER4Care Program for Older Adults Supported by Residential and Daycare Facilities (REMINDER4Care)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Catarina L. B. Baptista, PhD Student
- Phone Number: +351 963 031 318
- Email: catarinalbbaptista23@gmail.com
Study Locations
-
-
Portugal
-
Coimbra, Portugal, Portugal, 3000-115
- Recruiting
- Faculty of Psychology and Education Sciences
-
Contact:
- Catarina L. B. Baptista, PhD student
- Phone Number: +351 963 031 318
- Email: catarinallbaptista23@gmail.com
-
Principal Investigator:
- Catarina L. B. Baptista, PhD Student
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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
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
Sponsor
Collaborators
Investigators
- 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
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- RCTREMINDER4Care
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
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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