Subjective Memory Complaints' Cognitive Intervention

NCT05720585 | Unknown DMC

• 1 other identifier: NMU-IRB-(2019)437
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Subjective Memory Complaint

Outcome Measures

Primary Outcomes (4)

• Subjective Memory Complaint (SMC)

  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.

  Change from Baseline Subjective Memory Complaint at 1 month

• Cognitive Function

  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. .

  Change from Baseline Cognitive function at 1 month

• Memory

  The Auditory Verbal Learning Test (AVLT), developed by Kwak in 2001, is used to test the verbal memory function of the older adults.

  Change from Baseline Memory at 1 month

• The Quality of Life Rating Scale (SF-12)

  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.

  Change from Baseline Quality of Life at 1 month

Secondary Outcomes (1)

• Demographic characteristics

  Base line

Study Arms (1)

Intervention group

EXPERIMENTAL

Other: Intervention of mobile health application

Interventions

Intervention of mobile health application OTHER

According to the contents of the Subjective Memory Complaint (SMC) application intervention program for the older adults previously formulated, the intervention time and the frequency (30min / time, once a week) of each training module and other contents were determined. The application will be implemented and lasted for a total of 1 month.

Intervention group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hongli Chen: lead

Central Study Contacts

Xianwen Li, PhD

CONTACT

86-025-86869557; xwli0201@njmu.edu.cn

Hongli Chen, Master

CONTACT

86-13260702093; chenhl@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research assistant

Study Record Dates

• First Submitted: December 11, 2022
• First Posted: February 9, 2023
• Study Start: February 15, 2023
• Primary Completion: June 30, 2023
• Study Completion: December 31, 2023
• Last Updated: February 9, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share