Nurse-led Clinics Training Program on Mild Cognitive Impairment Patients

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06198530
• Other study ID #: 2021029
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: August 2023
• Source: Xuanwu Hospital, Beijing
• Contact: yuchen Qiao
• Phone: 01083192331
• Email: qiaoyc2015[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
China	Xuanwu Hospital, Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

References & Publications (5)

Benedict 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. — View Citation

How 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.

Jia 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. — View Citation

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. — View Citation

Wang 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Montreal Cognitive Assessment (MoCA)	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
Secondary	Change in World Health Organization-University of California-Los Angeles Auditory Verbal Learning Test (WHO-UCLA AVLT)	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
Secondary	Change in Boston Naming Test (BNT)	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
Secondary	Change in Instrumental activities of daily living(IADL)	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
Secondary	Change in the barthel index(BI)	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
Secondary	Change in Hamilton Anxiety rating scale(HARS)	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
Secondary	Change in Geriatric depression scale(GDS)	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
Secondary	Change in Cohen-Mansfield Agitation Inventory (CMAI)	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
Secondary	Change in Neuropsychiatric Inventory(NPI)	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
Secondary	Change in Zarit caregiver burden interview (ZBI)	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
Secondary	Change in Resting EEG	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 kO. 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