Subjective Memory Complaints' Cognitive Intervention

Not Applicable

Not yet recruiting

• Conditions: Subjective Memory Complaint
• Interventions: Other: Intervention of mobile health application

• Registration Number: NCT05720585
• Lead Sponsor: Hongli Chen

Brief Summary

This study will be divided into two parts: development of the mobile medical application for older adults with subjective memory decline and the intervention application. Start by developing and optimizing the application based on the rapid prototyping model. Then, in accordance with the framework of designing and evaluating complex intervention measures proposed by the Medical Research Council of the United Kingdom, pre-experiments will be carried out to apply the developed application to the actual intervention process to test the intervention effect, feasibility, and other contents of the application.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-11
• Status Verified: 2023-01
• Study First Submitted QC: 2023-02-08
• Last Update Submitted: 2023-02-08
• Study First Posted: 2023-02-09
• Last Update Posted: 2023-02-09
• Study Start: 2023-02-15
• Primary Completion: 2023-06-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Patients with subjective memory complaints by SMCQ for 6 months and above.
• Individuals age over 60 years (depending on the characteristics of the disease, it can be relaxed to 55 years) are included.
• Older adults owning and being able to use smartphones to access the Internet, or whose caregivers can assist in the completion can also be included.
• Older adults who voluntary participate in the study and provide informed consent are also included.

Exclusion Criteria

• Older adults diagnosed with cognitive or mild cognitive impairment.
• Older adults diagnosed with other neurological disorders ( cerebrovascular disease, encephalitis, brain tumor, brain trauma, epilepsy, Parkinson 's disease, depression, mania, etc. ), metabolic diseases ( anemia, thyroid dysfunction, folic acid and vitamin B12 deficiency, etc. ), carbon monoxide poisoning and cognitive decline caused by general anesthesia
• Older adults with serious medical and surgical diseases who cannot complete the experiment are also excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention group	Intervention of mobile health application	-

Primary Outcome Measures

Name	Time	Method
The Quality of Life Rating Scale (SF-12)	Change from Baseline Quality of Life at 1 month	The Quality of Life Rating Scale (SF-12) is used. There are 12 items in total, with 8 dimensions, which are general health, physiological function, physiological function, physical pain, mental health, vitality, social function and emotional function. The eight dimensions can be summarized into two comprehensive indicators of physical health and mental health.
Cognitive Function	Change from Baseline Cognitive function at 1 month	Montreal Cognitive Assessment (MoCA) is adopted, which includes 8 aspects of cognitive domain assessment. The total score of this scale is 30 points, the higher the score is, the better the cognitive function will be. .
Memory	Change from Baseline Memory at 1 month	The Auditory Verbal Learning Test (AVLT), developed by Kwak in 2001, is used to test the verbal memory function of the older adults.
Subjective Memory Complaint (SMC)	Change from Baseline Subjective Memory Complaint at 1 month	Subjective Memory Complaint Questionnaire (SMCQ), a SMC self-assessment questionnaire designed for the elderly population, is adopted. There are 14 items in 2 dimensions. The first 4 items are used to evaluate the overall memory and the last 10 items are used to evaluate the daily memory.

Secondary Outcome Measures

Name	Time	Method
Demographic characteristics	Base line	General demographic of the older adults with memory complaints are obtained by self-made questionnaires including age, gender, education, occupation, whether they live alone, and chronic diseases.