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Completed

NCT Number: NCT06733181

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

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.

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Key information

Conditions

Aging, Healthy Alzheimer Disease Behavior Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Old Age; Dementia Risk Reduction Risk Reduction Behavior Social Behavior Social Isolation Tauopathies

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Psychology and Education Sciences

Coimbra, Portugal, 3000-115

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

REMINDER intervention

Other

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

Primary outcomes

  1. Feasibility outcomes (quantitative)

    Time frame: During the intervention (at the end of the sessions) and 1-week after the intervention

    Recruitment rate

  2. Feasibility outcomes (quantitative)

    Time frame: During the intervention (at the end of the sessions) and 1-week after the intervention

    Adherence

  3. Feasibility outcomes (quantitative)

    Time frame: During the intervention (at the end of the sessions) and 1-week after the intervention

    Retention

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. Preliminary efficacy data (screening)

    Time frame: Screening

    Participants' sociodemographic (age in years).

  2. Preliminary efficacy data (screening)

    Time frame: Screening

    Participants' sociodemographic (marital status).

  3. Preliminary efficacy data (screening)

    Time frame: Screening

    Participants' sociodemographic (education level).

  4. Preliminary efficacy data (screening)

    Time frame: Screening

    Participants' clinical information (presence of medical diagnosis).

  5. Preliminary efficacy data (screening)

    Time frame: Screening

    Participants' clinical information (current medication).

  6. Preliminary efficacy data (screening)

    Time frame: Screening

    Participants' clinical information (sensory issues).

  7. Preliminary efficacy data (screening)

    Time frame: Screening

    Participants' clinical information (mobility deficits).

  8. Preliminary efficacy data (screening)

    Time frame: Screening

    Participants' clinical information (substance use).

  9. Preliminary efficacy data (screening)

    Time frame: Screening

    Participants' clinical information (hospitalization).

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

Sponsors and collaborators

Lead sponsor

University of Coimbra

Other

Registry information

Official study title

The REMINDER, a Multidomain Dementia Risk Reduction Program for Older Adults Supported by Residential Care Facilities: a Feasibility Study

Acronym: REMINDER

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 13, 2024
Registry last updated
Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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