Clinical trial NCT06198530: Nurse-led Clinics Training Program on Mild Cognitive Impairment Patients
Official title: Effectiveness of Nurse-led Clinics Training Program on Mild Cognitive Impairment Patients: a Randomized Controlled Trial Protocol
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: nurse-led clinics
computerized cognitive training
randomized controlled clinical trial
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in Mini-Mental State Examination (MMSE)
timeFrame: From baseline to the 6-month and 12-month after intervention
Secondary outcomes:
measure: Change in Montreal Cognitive Assessment (MoCA)
timeFrame: From baseline to the 6-month and 12-month after intervention
measure: Change in World Health Organization-University of California-Los Angeles Auditory Verbal Learning Test (WHO-UCLA AVLT)
timeFrame: From baseline to the 6-month and 12-month after intervention
measure: Change in Boston Naming Test (BNT)
timeFrame: From baseline to the 6-month and 12-month after intervention
measure: Change in Instrumental activities of daily living(IADL)
timeFrame: From baseline to the 6-month and 12-month after intervention
measure: Change in the barthel index（BI）
timeFrame: From baseline to the 6-month and 12-month after intervention
measure: Change in Hamilton Anxiety rating scale(HARS)
timeFrame: From baseline to the 6-month and 12-month after intervention
measure: Change in Geriatric depression scale(GDS)
timeFrame: From baseline to the 6-month and 12-month after intervention
measure: Change in Cohen-Mansfield Agitation Inventory (CMAI)
timeFrame: From baseline to the 6-month and 12-month after intervention
measure: Change in Neuropsychiatric Inventory(NPI)
timeFrame: From baseline to the 6-month and 12-month after intervention
measure: Change in Zarit caregiver burden interview (ZBI)
timeFrame: From baseline to the 6-month and 12-month after intervention
measure: Change in Resting EEG
timeFrame: From baseline to the 6-month and 12-month after intervention
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
Study officials:
References:
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