Impact of the Digital Multi-domain Cognitive Intervention in High-risk Populations for Dementia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Global cognitive function
研究概览
简要总结
Dementia is a chronic, progressive neurodegenerative disease characterized by acquired cognitive impairment as its core manifestation. The most common type of dementia is Alzheimer's Disease (AD), also known as "Senile Dementia," accounting for 60-80% of all dementia cases. Currently, there are approximately 10 million AD patients in China, with the number showing an increasing trend year by year, imposing a heavy economic and caregiving burden on families and society. Studies have shown that AD has a clinically silent period of 15 to 20 years (SCD\MCI), where the risk of developing dementia is ten times higher than that of healthy elderly individuals. Nearly 50% of MCI patients progress to dementia within 5 years, and about 14.1% of SCD patients develop dementia within the same timeframe. Early detection, diagnosis, and intervention are currently the most effective strategies for preventing and treating AD. Therefore, this study aims to verify the intervention effect of integrated cognitive intervention in high-risk populations for senile dementia (SCD, MCI) based on the cognitive rehabilitation model through randomized controlled trials, and to analyze attrition rates, participation rates, etc., which have good research and application value.
详细描述
Based on the cognitive rehabilitation model, this study aims to develop a digital multimodal cognitive intervention program, and conduct feasibility studies and randomized controlled trials. The intervention includes health knowledge education, exercise intervention, art intervention, and cognitive training, etc. The feasibility, effectiveness, and safety of this intervention approach will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MCI (refer to Peterson's diagnostic criteria) or SCD (refer to the diagnostic framework proposed by Jak bondi and Jessen et al.);
- •Able to communicate normally in Mandarin;
- •Certain level of comprehension and judgment abilities, aware of the purpose of the survey and consents to participate.
排除标准
- •Patients with dementia exhibiting abnormal mental behavior;
- •Individuals with severe hearing or speech impairments;
- •Those with serious physical illnesses who are unable to cooperate and complete the survey.
研究组 & 干预措施
Intervention group
Participants in the intervention group received the digtal multi-domain cognitive intervention. The digital multi-domain cognitive intervention system is used to carry out various intervention activities. The activities include learning about health knowledge once a week; home-based exercise three times per week, for 30 minutes each time; art therapy once a week, for 90 minutes at a time; and cognitive training, which includes memory, attention, executive function, and visuospatial training, conducted three times per week, with each session lasting 30 minutes.
干预措施: Multi-domain Cognitive Intervention (Behavioral)
Control group
Participant in the control group reveived the health education , once a week, covering the prevention and treatment of chronic diseases in the elderly, as well as healthy lifestyles for the elderly
干预措施: Multi-domain Cognitive Intervention (Behavioral)
结局指标
主要结局
Global cognitive function
时间窗: Baseline (pre-intervention), six-month follow-up (post-intervention)
The Chinese version of Montreal Cognitive Assessment will be used to assess the global cognitive function.The scale has a total score of 30 points, encompassing eight assessment sections: visual-spatial and executive function, naming, memory, attention, language, abstraction, delayed recall, and orientation. It involves multiple cognitive domains. A higher score indicates better cognitive functioning.
次要结局
- Naming difficulty(Baseline (pre-intervention), six-month follow-up (post-intervention))
- Lonliness(Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention))
- Anxiety(Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention))
- Self-esteem(Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention))
- Social network(Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention))
- Memory(Baseline (pre-intervention), six-month follow-up (post-intervention))
- Verbal fluency(Baseline (pre-intervention), six-month follow-up (post-intervention))
- Visuospatial skills(Baseline (pre-intervention), six-month follow-up (post-intervention))
- Health-Promoting Lifestyle(Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention))
- Abilities for health practices(Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention))
- Quality of life of Alzheimer's disease(Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention))
- Depression(Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention))
- Executive function(Baseline (pre-intervention), six-month follow-up (post-intervention))
- Self-efficacy(Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention))
- Sleep quality(Baseline (pre-intervention), six-month follow-up (post-intervention))
- Subjective cognitive function(Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention))
研究者
Yuanjiao Yan
Principal Investigator
Fujian Provincial Hospital