Nurse-led Clinics Training Program on Mild Cognitive Impairment Patients
- Conditions
- Mild Cognitive Impairment
- Interventions
- Behavioral: cognitive training in NLCsBehavioral: cognitive training in homeBehavioral: cognitive training in tradition
- Registration Number
- NCT06198530
- Lead Sponsor
- Xuanwu Hospital, Beijing
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 96
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description cognitive training in NLCs 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. cognitive training in home 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. cognitive training in tradition 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
- Primary Outcome Measures
Name Time Method Change in Mini-Mental State Examination (MMSE) 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.
- Secondary Outcome Measures
Name Time Method Change in Hamilton Anxiety rating scale(HARS) 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
Change in Zarit caregiver burden interview (ZBI) 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.
Change in Resting EEG 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.
Change in Montreal Cognitive Assessment (MoCA) 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.
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 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.
Change in the barthel index（BI） 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.
Change in Geriatric depression scale(GDS) 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
Change in Boston Naming Test (BNT) 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.
Change in Instrumental activities of daily living(IADL) 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.
Change in Cohen-Mansfield Agitation Inventory (CMAI) 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
Change in Neuropsychiatric Inventory(NPI) 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
Trial Locations
- Locations (1)
Xuanwu Hospital, Capital Medical University
🇨🇳Beijing, China