NCT06198530

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mild Cognitive Impairment

Interventions

Type	Name	Description
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.
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.
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.

Timeline

• Start date: 2024-01-15
• Primary completion: 2024-12-31
• Completion: 2025-06-30
• First posted: 2024-01-10
• Last updated: 2024-01-10

Locations

1 site across 1 country: China