Nurse-led Clinics Training Program on Mild Cognitive Impairment Patients
Effectiveness of Nurse-led Clinics Training Program on Mild Cognitive Impairment Patients: a Randomized Controlled Trial Protocol
1 other identifier
interventional
96
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2023
CompletedFirst Posted
Study publicly available on registry
January 10, 2024
CompletedStudy Start
First participant enrolled
January 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedJanuary 10, 2024
August 1, 2023
12 months
August 9, 2023
January 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Mini-Mental State Examination (MMSE)
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 Outcomes (11)
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 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 the barthel index（BI）
From baseline to the 6-month and 12-month after intervention
- +6 more secondary outcomes
Study Arms (3)
cognitive training in NLCs
ACTIVE COMPARATORcomputerized 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.
cognitive training in home
ACTIVE COMPARATORCCT 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.
cognitive training in tradition
PLACEBO COMPARATORthe 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
Interventions
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.
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.
In the traditional training group, the Home Cognitive Training Manual for Alzheimer's Disease compiled by our research team was distributed.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xuanwu Hospital, Capital Medical University
Beijing, 100053, China
Related Publications (5)
Sanford AM. Mild Cognitive Impairment. Clin Geriatr Med. 2017 Aug;33(3):325-337. doi: 10.1016/j.cger.2017.02.005. Epub 2017 May 17.
PMID: 28689566BACKGROUNDJia L, Du Y, Chu L, Zhang Z, Li F, Lyu D, Li Y, Li Y, Zhu M, Jiao H, Song Y, Shi Y, Zhang H, Gong M, Wei C, Tang Y, Fang B, Guo D, Wang F, Zhou A, Chu C, Zuo X, Yu Y, Yuan Q, Wang W, Li F, Shi S, Yang H, Zhou C, Liao Z, Lv Y, Li Y, Kan M, Zhao H, Wang S, Yang S, Li H, Liu Z, Wang Q, Qin W, Jia J; COAST Group. Prevalence, risk factors, and management of dementia and mild cognitive impairment in adults aged 60 years or older in China: a cross-sectional study. Lancet Public Health. 2020 Dec;5(12):e661-e671. doi: 10.1016/S2468-2667(20)30185-7.
PMID: 33271079BACKGROUNDWang Q, Zhang Z, Li L, Wen H, Xu Q. Assessment of cognitive impairment in patients with Parkinson's disease: prevalence and risk factors. Clin Interv Aging. 2014 Feb 12;9:275-81. doi: 10.2147/CIA.S47367. eCollection 2014.
PMID: 24550669BACKGROUNDBenedict RHB, Amato MP, DeLuca J, Geurts JJG. Cognitive impairment in multiple sclerosis: clinical management, MRI, and therapeutic avenues. Lancet Neurol. 2020 Oct;19(10):860-871. doi: 10.1016/S1474-4422(20)30277-5. Epub 2020 Sep 16.
PMID: 32949546BACKGROUNDHow Many People Have Dementia and What Is the Cost of Dementia Care? Alzheimer's Society.2019. URL: https://www. alzheimers.org.uk/about-us/policy-and-influencing/dementia-scale-impact-numbers.
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- 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.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2023
First Posted
January 10, 2024
Study Start
January 15, 2024
Primary Completion
December 31, 2024
Study Completion
June 30, 2025
Last Updated
January 10, 2024
Record last verified: 2023-08