Nurse-led Clinics Training Program on Mild Cognitive Impairment Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-15

Study Completion Date

2025-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

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.

Study Groups

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cognitive training in NLCs

computerized cognitive training (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. All the patients were capable of performing the training under the guidance of advanced practicing nurses (APNs). At the same time, according to the caregivers' feedback, APNs will give them the desired care guidance.

Group Type ACTIVE_COMPARATOR

cognitive training in NLCs

Intervention Type 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

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. The data results of each training will be automatically stored in the personal information database in the cloud. And, a training report will be generated, including training difficulty, training results and training time. Nurses can examine patients' training through the cloud.

Group Type ACTIVE_COMPARATOR

cognitive training in home

Intervention Type 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

the Home Cognitive Training Manual for Alzheimer's Disease compiled by our research team was distributed. And, the patients and their families were given detailed health education on the definition, clinical manifestations, drug and non-drug treatment, home nursing, the significance of cognitive training and the methods of cognitive training. Meanwhile, we established connection with patients for later follow-up

Group Type PLACEBO_COMPARATOR

cognitive training in tradition

Intervention Type BEHAVIORAL

In the traditional training group, the Home Cognitive Training Manual for Alzheimer's Disease compiled by our research team was distributed.

Interventions

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cognitive training in NLCs

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.

Intervention Type BEHAVIORAL

cognitive training in home

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.

Intervention Type BEHAVIORAL

cognitive training in tradition

In the traditional training group, the Home Cognitive Training Manual for Alzheimer's Disease compiled by our research team was distributed.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No