Nurse-led Clinics Training Program on Mild Cognitive Impairment Patients

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.

• cognitive training in NLCs (Behavioral): In the nurse-led clinics(NLCs) training group, CCT was given twice a week during 1-6 months and once a week during 7-12 month in nursing clinic. There is 60 minutes at a time.
• cognitive training in home (Behavioral): In the home-based training group, CCT was given four times a week during 1-6 months and twice a week during 7-12 month in nursing clinic. There is 30 minutes at a time. Nurses teach patients to acquire and carry out CCT at home during hospitalization. Nurses set the daily reminder function at 9:00am through training system.
• cognitive training in tradition (Behavioral): In the traditional training group, the Home Cognitive Training Manual for Alzheimer's Disease compiled by our research team was distributed.

Primary outcomes

• Change in Mini-Mental State Examination (MMSE) [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.

Secondary outcomes

• Change in Montreal Cognitive Assessment (MoCA) [From baseline to the 6-month and 12-month after intervention]: Montreal Cognitive Assessment in which scores range from 0 to 30, with higher scores representing better general cognitive performance.
• 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]: World Health Organization-University of California-Los Angeles Auditory Verbal Learning Test , which scores range from 0 to 45 will be used to assess memory function in which scores range from 0 to 45, with a higher value representing a better outcome.
• Change in Boston Naming Test (BNT) [From baseline to the 6-month and 12-month after intervention]: Boston Naming Test in which scores range from 0 to 30 will be used to assess language performance, specifically visual naming ability.
• Change in Instrumental activities of daily living(IADL) [From baseline to the 6-month and 12-month after intervention]: Instrumental activities of daily living in which scores range from 0 to 24 were defined as being whether able to complete Instrumental activity ability.
• Change in the barthel index（BI） [From baseline to the 6-month and 12-month after intervention]: the barthel index in which scores range from 0 to 100 were defined as being whether able to complete basic activity ability.
• Change in Hamilton Anxiety rating scale(HARS) [From baseline to the 6-month and 12-month after intervention]: Hamilton Anxiety rating scale in which scores range from 0 to 56 measures14 items, adopt Likert5 level score, the higher the score according to the more serious the degree of anxiety
• Change in Geriatric depression scale(GDS) [From baseline to the 6-month and 12-month after intervention]: Geriatric depression scale measures 30 items，in which scores range from 0 to 30. The higher the score according to the more serious the degree of depression
• Change in Cohen-Mansfield Agitation Inventory (CMAI) [From baseline to the 6-month and 12-month after intervention]: The Cohen-Mansfield Agitation Inventory measures 29 agitated or aggressive behaviors. The frequency of each symptom is rated on a seven-point scale (1-7) ranging from "never" to "several times an hour."the scores range from 29 to 203. The higher the score according to the more serious the degree of agitation
• Change in Neuropsychiatric Inventory(NPI) [From baseline to the 6-month and 12-month after intervention]: The Neuropsychiatric Inventory consists of 12 items that are assayed with questions, subquestions, and ratings of frequency and severity. the scores range from 0 to 144. The higher the score according to the more serious the degree of mental and behavioral abnormalities
• Change in Zarit caregiver burden interview (ZBI) [From baseline to the 6-month and 12-month after intervention]: Zarit caregiver burden interview contains 29 items on a four-point Likert scale, will be used to assess the burden of caregivers.
• Change in Resting EEG [From baseline to the 6-month and 12-month after intervention]: EEG was acquired using a 32-conductor electrode cap and amplifier (BioSemi, Amsterdam, Netherlands) with a 2048-Hz sampling rate. To reduce interference during signal acquisition, we ensured that the electrode resistance was<5 kΩ. During data collection, the participants were seated in a comfortable chair, relaxed, refrained from speech or voluntary movements, and kept their eyes closed. The eyes-closed state was recorded for 5 min, and the data were stored on a computer for offline analysis.

Sex: All, ages: 18 Years to any

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.

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• Study Protocol and Statistical Analysis Plan (PDF, 2024-01-03)