Clinical trial NCT06733181: The REMINDER Program for Older Adults Supported by Residential and Daycare Facilities
Official title: The REMINDER, a Multidomain Dementia Risk Reduction Program for Older Adults Supported by Residential Care Facilities: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging, Healthy
Risk Reduction
Old Age; Dementia
Keywords: Dementia risk reduction
Older adults
Multidomain programs
Residential and Daycare Facilities
Social Isolation
Loneliness
Lead sponsor: University of Coimbra
Sponsor class: OTHER
First posted: 2024-12-13
Enrollment: 25
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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:

1. To evaluate the acceptance rate of RDF and participants to join the research;
2. To determine the suitability of participant eligibility criteria by estimating feasible eligibility and recruitment rates;
3. To measure participant adherence and retention through attendance rates across all intervention sessions and trends over time;
4. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility outcomes (quantitative)
timeFrame: During the intervention (at the end of the sessions) and 1-week after the intervention
measure: Feasibility outcomes (quantitative)
timeFrame: During the intervention (at the end of the sessions) and 1-week after the intervention
measure: Feasibility outcomes (quantitative)
timeFrame: During the intervention (at the end of the sessions) and 1-week after the intervention
measure: Feasibility outcomes (qualitative)
timeFrame: During the intervention (at the end of the sessions) and 1-week after the intervention
measure: Feasibility outcomes (qualitative)
timeFrame: During the intervention (at the end of the sessions) and 1-week after the intervention
measure: Feasibility outcomes (qualitative)
timeFrame: During the intervention (at the end of the sessions) and 1-week after the intervention
Secondary outcomes:
measure: Preliminary efficacy data (screening)
timeFrame: Screening
measure: Preliminary efficacy data (screening)
timeFrame: Screening
measure: Preliminary efficacy data (screening)
timeFrame: Screening
measure: Preliminary efficacy data (screening)
timeFrame: Screening
measure: Preliminary efficacy data (screening)
timeFrame: Screening
measure: Preliminary efficacy data (screening)
timeFrame: Screening
measure: Preliminary efficacy data (screening)
timeFrame: Screening
measure: Preliminary efficacy data (screening)
timeFrame: Screening
measure: Preliminary efficacy data (screening)
timeFrame: Screening
measure: Preliminary efficacy data (screening)
timeFrame: Screening
measure: Preliminary efficacy data (screening)
timeFrame: Screening and 1-week post-intervention
measure: Preliminary efficacy data (screening)
timeFrame: Screening and 1-week post-intervention
measure: Preliminary efficacy data (Cognitive functions)
timeFrame: Baseline and 1-week post-intervention
measure: Preliminary efficacy data (Cognitive functions)
timeFrame: Baseline and 1-week post-intervention
measure: Preliminary efficacy data (Cognitive functions)
timeFrame: Baseline and 1-week post-intervention
measure: Preliminary efficacy data (Cognitive functions)
timeFrame: Baseline and 1-week post-intervention
measure: Preliminary efficacy data (Psychosocial/ Mental Health indicators)
timeFrame: Baseline and 1-week post-intervention
measure: Preliminary efficacy data (Psychosocial/ Mental Health indicators)
timeFrame: Baseline and 1-week post-intervention
measure: Preliminary efficacy data (Psychosocial/ Mental Health indicators)
timeFrame: Baseline and 1-week post-intervention
measure: Preliminary efficacy data (Psychosocial/ Mental Health indicators)
timeFrame: Baseline and 1-week post-intervention
measure: Preliminary efficacy data (Psychosocial/ Mental Health indicators)
timeFrame: Baseline and 1-week post-intervention
measure: Preliminary efficacy data (Perceived and performance-based functional status)
timeFrame: Baseline and 1-week post-intervention
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: Faculty of Psychology and Education Sciences
Study officials:
References: