SMCCI: Subjective Memory Complaints' Cognitive Intervention

Sponsor

Hongli Chen (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05720585

Collaborator

(none)

Enrollment

Arm

10.5

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Subjective Memory Complaint	Other: Intervention of mobile health application	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Feb 15, 2023

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Hongli Chen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hongli Chen, Research assistant, Nanjing Medical University

ClinicalTrials.gov Identifier:

NCT05720585

Other Study ID Numbers:

NMU-IRB-(2019)437

First Posted:

Feb 9, 2023

Last Update Posted:

Feb 9, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Feb 9, 2023