Effectiveness of Nurse-led Clinics Training Program on Mild Cognitive Impairment Patients: a Randomized Controlled Trial Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Change in Mini-Mental State Examination (MMSE)
研究概览
简要总结
This trail is the first study to test the efficacy of nurse-led clinics cognitive training on mild cognitive impairment (MCI) patients using a single-blind, randomized controlled trial design. The investigators hypothesize that nurse-led clinics cognitive training can (a)decelerate or ameliorate cognitive decline, (b)ameliorate anxiety and depressive symptoms, (c)increase the quality of life for both patients and family members, (d)improve the ability of daily life, (e)reduce the incidence of agitation.
详细描述
Introduction
Globally, nurse-led clinics(NLCs) have been developed to serve and follow up on patients who have just been discharged from the hospital. NLCs cognitive training program as a potentially effective and promising treatment for MCI patients.
Methods: The study is a single-blind, randomized-controlled trial. Eligible patients need to be diagnosed as MCI. Participants will be randomized into either a NLCs training group or a home-based training group. Both groups will undergo total 72hour across 12 months. The outcome measures will be assessed at baseline, at the 6 months and 12 months during the intervention. The primary outcome is global cognitive function, assessed by the 30-item the Mini-Mental State Examination (MMSE), and the secondary outcomes include changes in other neuropsychological assessments and in result of resting electroencephalography (EEG) .
Results: The trial is currently ongoing, and it is anticipated that recruitment will be completed in June 2025.
Discussion: This trial will evaluate the efficacy and safety of NLCs cognitive training in patients with MCI, and further explore the potential mechanisms by analyzing teh results of neuropsychological assessments and EEG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
Radiologists, statisticians, and neuropsychologists who measure the outcomes will be blinded to the randomization status. Blinding will also be maintained for data management, outcome assessment, and data analysis. Participants and therapists cannot be blinded to the intervention they receive or provide.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with informed consent;
- •Literate Han Chinese, above the age of 18;
- •At least 6 years of education;
- •Neither normal nor demented according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, with a Clinical Dementia Rating(CDR) ≥0.5 on at least one domain and a global score ≤0.5; a Mini-Menta State Examination score ≥20 (primary school), or ≥24 (junior school or above).
- •having normal vision and hearing with/without corrective devices.
排除标准
- •Severe aphasia, physical disabilities, or any other factor that might preclude completion of neuropsychological testing.
- •Clinically significant gastrointestinal, renal, hepatic, respiratory, infectious, endocrine, or cardiovascular system disease; cancer; alcoholism; drug addiction.
- •Illnesses affecting mobility or are unable to accept assessments or interventions that are required in this study.
结局指标
主要结局
Change in Mini-Mental State Examination (MMSE)
时间窗: From baseline to the 6-month and 12-month after intervention
The intervention will be assessed by the MMSE in which scores range from 0 to 30, with higher scores representing better general cognitive performance.
次要结局
- Change in Hamilton Anxiety rating scale(HARS)(From baseline to the 6-month and 12-month after intervention)
- Change in Zarit caregiver burden interview (ZBI)(From baseline to the 6-month and 12-month after intervention)
- Change in Resting EEG(From baseline to the 6-month and 12-month after intervention)
- Change in Montreal Cognitive Assessment (MoCA)(From baseline to the 6-month and 12-month after intervention)
- Change in World Health Organization-University of California-Los Angeles Auditory Verbal Learning Test (WHO-UCLA AVLT)(From baseline to the 6-month and 12-month after intervention)
- Change in the barthel index（BI）(From baseline to the 6-month and 12-month after intervention)
- Change in Geriatric depression scale(GDS)(From baseline to the 6-month and 12-month after intervention)
- Change in Boston Naming Test (BNT)(From baseline to the 6-month and 12-month after intervention)
- Change in Instrumental activities of daily living(IADL)(From baseline to the 6-month and 12-month after intervention)
- Change in Cohen-Mansfield Agitation Inventory (CMAI)(From baseline to the 6-month and 12-month after intervention)
- Change in Neuropsychiatric Inventory(NPI)(From baseline to the 6-month and 12-month after intervention)