The REMINDER, a Multidomain Dementia Risk Reduction Program for Older Adults Supported by Residential Care Facilities: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Feasibility outcomes (quantitative)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals aged 65 years and older
- •RDF users
- •Those with elementary reading and writing skills.
排除标准
- •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.
研究组 & 干预措施
REMINDER intervention
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.
干预措施: REMINDER intervention (Other)
结局指标
主要结局
Feasibility outcomes (quantitative)
时间窗: During the intervention (at the end of the sessions) and 1-week after the intervention
Recruitment rate
Feasibility outcomes (qualitative)
时间窗: 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.
次要结局
- Preliminary efficacy data (Psychosocial/ Mental Health indicators)(Baseline and 1-week post-intervention)
- Preliminary efficacy data (Cognitive functions)(Baseline and 1-week post-intervention)
- Preliminary efficacy data (screening)(Screening and 1-week post-intervention)
- Preliminary efficacy data (Perceived and performance-based functional status)(Baseline and 1-week post-intervention)
- Preliminary efficacy data (screening)(Screening)
研究者
Catarina Baptista
PhD Student
University of Coimbra