Nurse-led Clinics Training Program on Mild Cognitive Impairment Patients

January 7, 2024 updated by: Xuanwu Hospital, Beijing

Effectiveness of Nurse-led Clinics Training Program on Mild Cognitive Impairment Patients: a Randomized Controlled Trial Protocol

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 100053
        • Recruiting
        • Xuanwu Hospital, Capital Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Behavioral: 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.
Active Comparator: 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.
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.
Placebo Comparator: 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Mini-Mental State Examination (MMSE)
Time Frame: 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.
From baseline to the 6-month and 12-month after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Montreal Cognitive Assessment (MoCA)
Time Frame: 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.
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)
Time Frame: 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.
From baseline to the 6-month and 12-month after intervention
Change in Boston Naming Test (BNT)
Time Frame: 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.
From baseline to the 6-month and 12-month after intervention
Change in Instrumental activities of daily living(IADL)
Time Frame: 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.
From baseline to the 6-month and 12-month after intervention
Change in the barthel index（BI）
Time Frame: 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.
From baseline to the 6-month and 12-month after intervention
Change in Hamilton Anxiety rating scale(HARS)
Time Frame: 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
From baseline to the 6-month and 12-month after intervention
Change in Geriatric depression scale(GDS)
Time Frame: 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
From baseline to the 6-month and 12-month after intervention
Change in Cohen-Mansfield Agitation Inventory (CMAI)
Time Frame: 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
From baseline to the 6-month and 12-month after intervention
Change in Neuropsychiatric Inventory(NPI)
Time Frame: 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
From baseline to the 6-month and 12-month after intervention
Change in Zarit caregiver burden interview (ZBI)
Time Frame: 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.
From baseline to the 6-month and 12-month after intervention
Change in Resting EEG
Time Frame: 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.
From baseline to the 6-month and 12-month after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuanwu Hospital, Beijing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 15, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

August 9, 2023

First Submitted That Met QC Criteria

January 7, 2024

First Posted (Actual)

January 10, 2024

Study Record Updates

Last Update Posted (Actual)

January 10, 2024

Last Update Submitted That Met QC Criteria

January 7, 2024

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021029

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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