Subjective Memory ComplaintSMCCINCT05720585
Subjective Memory Complaints' Cognitive Intervention
A study testing Intervention of mobile health application in people with Subjective Memory Complaint, run by Hongli Chen.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Subjective Memory Complaint
- What is being tested?
- Intervention of mobile health application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Subjective Memory Complaint
- Being tested
- Intervention of mobile health application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention of mobile health applicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Other: Intervention of mobile health application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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. .
Measured: 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.
Measured: 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.
Measured: Change from Baseline Quality of Life at 1 month
Secondary outcomes (1)
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.
Measured: Base line
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start15 Feb 2023 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjective Memory ComplaintStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hongli Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hongli Chen, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05720585
- Sponsor's protocol ID
- NMU-IRB-(2019)437
- Acronym
- SMCCI
- Status last verified
- Jan 2023
- First submitted
- 11 Dec 2022
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention of Mobile Health Application for Older Adults With Subjective Memory Complaints
- ClinicalTrials.gov ID
- NCT05720585
- Acronym / sponsor ID
- SMCCI / NMU-IRB-(2019)437
- Conditions
- Subjective Memory Complaint
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hongli ChenUniversity, hospital or other
- Study start
- 15 Feb 2023 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 9 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Intervention of mobile health application |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention of mobile health applicationAccording 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. | Other | Intervention group |
Primary outcome
Subjective Memory Complaint (SMC)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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.
1 secondary outcome
Demographic characteristics
Time frame: Base line
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention of mobile health application in people with Subjective Memory Complaint, run by Hongli Chen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xianwen Li, PhD (86-025-86869557, xwli0201@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Memory Complaint (SMC) (time frame: Change from Baseline Subjective Memory Complaint at 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2023.