NCT06733181

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 20, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 29, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 13, 2024

Completed
Last Updated

April 23, 2025

Status Verified

April 1, 2025

Enrollment Period

1 year

First QC Date

November 29, 2024

Last Update Submit

April 17, 2025

Conditions

Keywords

Dementia risk reductionOlder adultsMultidomain programsResidential and Daycare FacilitiesSocial IsolationLoneliness

Outcome Measures

Primary Outcomes (6)

  • Feasibility outcomes (quantitative)

    Recruitment rate

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

  • Feasibility outcomes (quantitative)

    Adherence

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

  • Feasibility outcomes (quantitative)

    Retention

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

  • Feasibility outcomes (qualitative)

    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)

    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)

    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 Outcomes (22)

  • Preliminary efficacy data (screening)

    Screening

  • Preliminary efficacy data (screening)

    Screening

  • Preliminary efficacy data (screening)

    Screening

  • Preliminary efficacy data (screening)

    Screening

  • Preliminary efficacy data (screening)

    Screening

  • +17 more secondary outcomes

Study Arms (1)

REMINDER intervention

EXPERIMENTAL

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: REMINDER intervention

Interventions

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.

Also known as: REMINDER and my brain
REMINDER intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Psychology and Education Sciences

Coimbra, Portugal, 3000-115, Portugal

Location

MeSH Terms

Conditions

Risk Reduction BehaviorAlzheimer DiseaseSocial Isolation

Condition Hierarchy (Ancestors)

BehaviorDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersSocial Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

November 29, 2024

First Posted

December 13, 2024

Study Start

July 20, 2023

Primary Completion

July 31, 2024

Study Completion

October 26, 2024

Last Updated

April 23, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations