Mild Cognitive ImpairmentNCT06198530
Nurse-led Clinics Training Program on Mild Cognitive Impairment Patients
A study testing cognitive training in NLCs, cognitive training in home and cognitive training in tradition in people with Mild Cognitive Impairment, run by Xuanwu Hospital, Beijing at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- cognitive training in NLCs, cognitive training in home and cognitive training in tradition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, 100053
Qiao yu chen, master, 01083192331, qiaoyc2015@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- cognitive training in NLCs, cognitive training in home, cognitive training in tradition
- Keywords
- nurse-led clinics, computerized cognitive training, randomized controlled clinical trial
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive training in NLCsBehavioural
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 homeBehavioural
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 traditionBehavioural
In the traditional training group, the Home Cognitive Training Manual for Alzheimer's Disease compiled by our research team was distributed.
| Study group | Role | What they receive |
|---|---|---|
| cognitive training in NLCs | Active comparator | 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. Receives: Behavioral: cognitive training in NLCs |
| cognitive training in home | Active comparator | 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. Receives: Behavioral: cognitive training in home |
| cognitive training in tradition | Placebo comparator | 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 Receives: Behavioral: cognitive training in tradition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to the 6-month and 12-month after intervention
Secondary outcomes (11)
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.
Measured: 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)
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.
Measured: From baseline to the 6-month and 12-month after intervention
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.
Measured: From baseline to the 6-month and 12-month after intervention
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.
Measured: From baseline to the 6-month and 12-month after intervention
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.
Measured: From baseline to the 6-month and 12-month after intervention
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
Measured: From baseline to the 6-month and 12-month after intervention
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
Measured: From baseline to the 6-month and 12-month after intervention
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
Measured: From baseline to the 6-month and 12-month after intervention
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
Measured: From baseline to the 6-month and 12-month after intervention
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.
Measured: From baseline to the 6-month and 12-month after intervention
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 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.
Measured: From baseline to the 6-month and 12-month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start15 Jan 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198530
- Sponsor's protocol ID
- 2021029
- Status last verified
- Aug 2023
- First submitted
- 9 Aug 2023
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28689566Jia 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.
PubMed 33271079Wang 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.
PubMed 24550669Benedict 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.
PubMed 32949546How 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Nurse-led Clinics Training Program on Mild Cognitive Impairment Patients: a Randomized Controlled Trial Protocol
- ClinicalTrials.gov ID
- NCT06198530
- Acronym / sponsor ID
- 2021029
- Conditions
- Mild Cognitive Impairment
- Keywords
- nurse-led clinics, computerized cognitive training, randomized controlled clinical trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 15 Jan 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cognitive training in NLCs | Active comparator | Behavioral: cognitive training in NLCscomputerized 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 comparator | Behavioral: cognitive training in homeCCT 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 comparator | Behavioral: cognitive training in traditionthe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive training in NLCsIn 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. | Behavioural | cognitive training in NLCs |
| cognitive training in homeIn 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. | Behavioural | cognitive training in home |
| cognitive training in traditionIn the traditional training group, the Home Cognitive Training Manual for Alzheimer's Disease compiled by our research team was distributed. | Behavioural | cognitive training in tradition |
Primary outcome
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.
11 secondary outcomes
Change in Montreal Cognitive Assessment (MoCA)
Time frame: 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
Change in Boston Naming Test (BNT)
Time frame: 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
Change in the barthel index（BI）
Time frame: 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
Change in Geriatric depression scale(GDS)
Time frame: 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
Change in Neuropsychiatric Inventory(NPI)
Time frame: 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
Change in Resting EEG
Time frame: From baseline to the 6-month and 12-month after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Background: PubMed 28689566Sanford 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.
- Background: PubMed 33271079Jia 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.
- Background: PubMed 24550669Wang 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.
- Background: PubMed 32949546Benedict 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.
- BackgroundHow 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive training in NLCs, cognitive training in home and cognitive training in tradition in people with Mild Cognitive Impairment, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yuchen Qiao (01083192331, qiaoyc2015@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mini-Mental State Examination (MMSE) (time frame: From baseline to the 6-month and 12-month after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06198530, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024; AzTrials last refreshed its copy on 31 Oct 2026.