Effectiveness of Non-pharmacological Interventions for Dementia Among Elderly in Hai Duong Province, Vietnam
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Changes from Clinical Dementia Rating Questionnaire at 3, and 6 months
研究概览
简要总结
This is a randomized controlled intervention aimed at improving cognitive decline in patients with dementia. The program includes exercise, cognitive training, and dementia education. The output index is expected to be an improvement in cognition, accompanied by an improvement in fitness, sleep quality, reduction in depression levels, and an improvement in quality of life. This is a program that is expected to be effective, inexpensive, easy to apply and does not require high expertise. A total of 50 dementia patients diagnosed and managed by the National Geriatric Hospital, Hai Duong Province General Hospital will be included in the study for 6 months. Patients were randomly assigned to an intervention group and received a program of physical exercise, cognitive training, dementia lecture, and long-term follow-up, or entered a control group to hear a lecture. about dementia. Cognition and fitness will be assessed after follow-up at 0, 3, and 6 months. This work is sponsored by Vingroup Joint Stock Company and supported by domestic Masters/Ph.D. The scholarship program of Vingroup Innovation Fund (VINIF), Vingroup Big Data Institute (VINBIGDATA).
详细描述
Dementia is a syndrome including memory impairment and other cognitive disorders; that interfere with social and/or professional functioning. The number of people with dementia globally is estimated to increase from 25 million in 2000 to 63 million in 2030. In 2016, dementia was the fifth leading cause of death globally, with approximately 2.4 million people, and one of the leading causes of disability and dependency in the elderly. This affects not only people with dementia but also carers, families, communities, and society; thus, it increases the financial burden on the health system. Healthcare costs for dementia amounted to about $800 billion (accounting for 1% of global GDP) in 2015 and are expected to reach $2 trillion by 2030. Study design: Cluster randomized controlled trial
Study location, time, and subject:
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Location: communes of Thanh Mien district and Gia Loc district of Hai Duong province, Vietnam - the exact location of the REACH Project.
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Time: From 1st January 2021 to 12th December 2022. The investigators started the intervention 6 months after the end of the care capacity-building arm of the REACH project.
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Participants: elderly who are diagnosed with mild and moderate dementia from the aim 1
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Inclusive criteria: (1) elderly (aged 60 years or above) who are living in Thanh Mien district and Gia Loc district of Hai Duong province; (2) Diagnosed with very mild, mild, and moderate dementia by the Clinical Dementia Assessment (CDR) Questionnaire, corresponding to CDR = 0.5, CDR = 1 and CDR = 2.
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Exclusive criteria: (1) Not physically fit to participate in physical exercises; (2) Having cardiovascular diseases.
Sample size and sampling process:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elderly (aged 60 years or above).
- •Living in Thanh Mien district and Gia Loc district of Hai Duong province.
- •Diagnosed with very mild, mild and moderate dementia by the Clinical Dementia Assessment (CDR) Questionnaire, corresponding to CDR = 0.5, CDR = 1 and CDR = 2.
排除标准
- •Not physically fit to participate in physical exercises.
- •Having cardiovascular diseases.
结局指标
主要结局
Changes from Clinical Dementia Rating Questionnaire at 3, and 6 months
时间窗: Baseline, 3, and 6 months post intervention
The questionnaire consists of 2 parts: Part 1 is for information providers (relatives/carers), part 2 is for patients, comparing the information provided to evaluate sixaspects, including Memory, Force Orientation, Evaluation - problem-solving, Social activities, Housework - hobbies and Self-care. The study will stimulate both the component scores and the total scores for the dementia grade. The sensitivity of the CDR was 93.6%, a specificity of 100%1. The CDR scale is divided into 5 levels: 0 (No Dementia), 0.5 (Very Mild Dementia), 1 (Mild Dementia), 2 (Moderate Dementia), 3 (Severe dementia).The higher the score, the more severe the dementia
次要结局
- Changes from Geriatric Depression Scale-15 at 3, and 6 months(Baseline, 3, and 6 months post intervention)
- Changes from Pittsburgh sleep quality index at 3, and 6 months(Baseline, 3, and 6 months post intervention)
- Changes from EuroQoL-5 dimensions-5 levels at 3, and 6 months(Baseline, 3, and 6 months post intervention)
- Changes from International Physical Activity Questionnaire - Short Form at 3, and 6 months(Baseline, 3, and 6 months post intervention)
研究者
Vu Thu Huong, MD
Principal Investigator
Hanoi Medical University