Subjective Memory Complaints' Cognitive Intervention (SMCCI)

Intervention of Mobile Health Application for Older Adults With Subjective Memory Complaints

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Subjective Memory Complaint
• Intervention / Treatment: Other: Intervention of mobile health application

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xianwen Li, PhD; Phone Number: 86-025-86869557; Email: xwli0201@njmu.edu.cn
• Study Contact Backup: Name: Hongli Chen, Master; Phone Number: 86-13260702093; Email: chenhl@njmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention group	Other: Intervention of mobile health application; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic characteristics	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.	Base line

Collaborators and Investigators

• Sponsor: Hongli Chen

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 15, 2023
• Primary Completion (ANTICIPATED): June 30, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: December 11, 2022
• First Submitted That Met QC Criteria: February 8, 2023
• First Posted (ESTIMATE): February 9, 2023

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: February 8, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: NMU-IRB-(2019)437

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No