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

NCT06922071 | Recruiting DMC

• 1 other identifier: RCTREMINDER4Care
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dementia Risk Factors; Prevention; Cognitive Health

Keywords

Dementia Risk Factors; Prevention; Health; Aging; Residential and Daycare Facilities; Lifestyle

Outcome Measures

Primary Outcomes (10)

• 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

  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

  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

  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

  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

  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

  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

  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

  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

  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

Study Arms (2)

REMINDER4Care intervention

EXPERIMENTAL

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

Waiting-list group

NO INTERVENTION

In this arm, participants will be a waiting-list group and receive the REMINDER4Care interventions after the study ends (after the post-interventions).

Interventions

REMINDER4Care OTHER

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.

REMINDER4Care intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundação para a Ciência e a Tecnologia: collaborator
• University of Coimbra: lead

Study Sites (1)

Faculty of Psychology and Education Sciences

Coimbra, Portugal, 3000-115, Portugal

RECRUITING

Related Links

• Website REMINDER

Study Officials

• Catarina L. B. Baptista, PhD Student

  University of Coimbra

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Central Study Contacts

Catarina L. B. Baptista, PhD Student

CONTACT

+351 963 031 318; catarinalbbaptista23@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 10, 2025
• Study Start: May 1, 2025
• Primary Completion: July 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 1, 2026

Record last verified: 2025-04

Locations

PT (1)