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临床试验/NCT06733181
NCT06733181
已完成
不适用

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

University of Coimbra1 个研究点 分布在 1 个国家目标入组 25 人2023年7月20日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Aging, Healthy
发起方
University of Coimbra
入组人数
25
试验地点
1
主要终点
Feasibility outcomes (quantitative)
状态
已完成
最后更新
去年

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: 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.

注册库
clinicaltrials.gov
开始日期
2023年7月20日
结束日期
2024年10月26日
最后更新
去年
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

责任方
Principal Investigator
主要研究者

Catarina Baptista

PhD Student

University of Coimbra

入排标准

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.

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

Retention

Feasibility outcomes (qualitative)

时间窗: 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.

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 (Perceived and performance-based functional status)(Baseline and 1-week post-intervention)
  • Preliminary efficacy data (screening)(Screening and 1-week post-intervention)

研究点 (1)

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