Validation Of The Flemish Montreal Cognitive Assessment (MoCA) For Persons With Hearing Impairment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- MoCA-HI
研究概览
简要总结
The Montreal Cognitive Assessment (MoCA) is a screening test for detecting cognitive impairment that assesses several cognitive domains (attention and concentration, arithmetic and orientation, memory, etc.). The instructions as well as some test items of the MoCA are presented auditory (spoken). Consequently, performance on the MoCA may be co-dependent on hearing. Therefore, to rule out the possible negative influence of hearing loss on performance on the MoCA, a MoCA for individuals with hearing loss was recently developed. More specifically, the original MoCA was modified by providing the instructions audiovisually (spoken with visual support) as well as by replacing hearing-dependent items. Since replacing items may affect sensitivity and specificity, the MoCA for persons with hearing loss should be revalidated.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged 60 years or older
- •Individuals with normal vision (with lenses or glasses if needed)
- •Individuals with age-related hearing loss
- •Dutch-speaking individuals
- •Individuals capable of giving consent to participate in the study themselves
- •Individuals still residing in their own homes
- •Individuals with an official diagnosis of dementia (Alzheimer's, vascular, or mixed) or mild cognitive impairment. This inclusion criterion applies only to the group with cognitive impairment.
排除标准
- •For individuals without cognitive impairment, the following exclusion criteria apply:
- •(History of) neurological problems (brain tumor, epilepsy, history of stroke, etc.)
- •Use of influencing medication (e.g., Ritalin and antidepressants)
结局指标
主要结局
MoCA-HI
时间窗: This parameter will be assessed once (during the first study visit) or twice (during the second study visit 4 weeks later), depending on the random selection for the test-retest group. Test duration is approximately 15 minutes.
The result (max 30) on the MoCA-HI will be calculated.
Hearing status
时间窗: This parameter will be assessed once during the first study visit of the patient. Test duration is approximately 20 minutes.
Based on the results of the tympanometry and pure-tone audiometry the hearing status of the participant will be classified as normal or abnormal. In case of abnormal hearing, the type and severity will be specified.
Hearing-related quality of life
时间窗: This parameter will be assessed once during the first study visit of the patient. Test duration is approximately 15 minutes.
Mean scores will be calculated for each subdomain separately (auditory-visual, cognitive, and psychosocial functioning) as well as combined within a total score. The scores can range from 0 to 100 whereby the worse one's hearing-related quality of life, the lower the score.
次要结局
未报告次要终点