Cognitive DeclineNCT05675137
Efficacy of a Mobile-based Multidomain Intervention to Improve Cognitive Function and Health-related Outcomes Among Older Korean Adults With a High Risk of Dementia
A study testing mobile-based and paper-based in people with Cognitive Decline and Cognitive Impairment, Mild, run by Silvia Health at 1 site in South Korea.
Trial summary
This study investigated the efficacy of the Silvia program, a mobile-based multidomain intervention, to improve cognitive function and health-related outcomes of older adults with a high risk of dementia. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Cognitive Decline, Cognitive Impairment, Mild, Aging
- What is being tested?
- mobile-based and paper-based
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Apr 2022to 28 Oct 2022
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- experiencing subjective cognitive decline,
- had a smart phone and could use it, and
- understood the purpose and process of this study.
Who cannot join
- major psychiatric disorders
- dementia,
- degenerative brain diseases
- severe or unstable heart diseases
- neurological or psychological diseases that affected cognitive functioning
- severe vision or hearing impairment,
- current participation in a cognitive training program
- does not know how to use mobile devices.
Trial locations and contacts
1 site in 1 country.
About this study
This study investigated the efficacy of the Silvia program, a mobile-based multidomain intervention, to improve cognitive function and health-related outcomes of older adults with a high risk of dementia. We compare its effects to a conventional paper-based multidomain program on various health indicators related to risk factors of dementia.
- Conditions
- Cognitive Decline, Cognitive Impairment, Mild, Aging, Dementia
- Being tested
- mobile-based, paper-based
- Medical subject headings
- Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile-basedDevice
Participants who were randomly assigned to the mobile-based intervention group were provided multidomain programs based on scientific evidence of ways to improve brain-health and reduce dementia risk for 10 minutes per day and at least 50 minutes per week.
paper-basedOther
Participants who were randomly assigned to the paper-based intervention group were provided with the Korean version of the dementia prevention booklet published by the WHO.
| Study group | Role | What they receive |
|---|---|---|
| Mobile-based multidomain intervention | Experimental | Not described Receives: Device: mobile-based |
| paper-based intervention group | Active comparator | Not described Receives: Other: paper-based |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Korean version of the Repeatable Battery for the Assessment of Neuropsychological status at 12 weeks
Cognitive function
Measured: baseline and after the 12-week intervention
Secondary outcomes (6)
Change from baseline Korean version of the mini-mental state examination, 2nd edition(K-MMSE-2) at 12 weeks
Cognitive function
Measured: baseline and after the 12-week intervention
Change form baseline Korean version of the prospective and retrospective memory questionnaire(K-PRMQ) at 12 weeks
Self-reported memory failures
Measured: baseline and after the 12-week intervention
Change from baseline Center for Epidemiological Studies Depression (CES-D) questionnaire at 12 weeks
Depression
Measured: baseline and after the 12-week intervention
Change from baseline State-Trait Anxiety Inventory-X-1(STAI-X-1) at 12 weeks
Anxiety
Measured: baseline and after the 12-week intervention
Change from baseline Perceived Stress Scale (PSS) at 12 weeks
Stress
Measured: baseline and after the 12-week intervention
Change from baseline EuroQoL 5-Dimension 5-Level(EQ-5D-5L) at 12 weeks
Health-related Quality of life
Measured: baseline and after the 12-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start10 Apr 2022
- Primary completion28 Oct 2022
- Study completion28 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeclineStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Silvia Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chosun University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05675137
- Sponsor's protocol ID
- 2022-03-013
- Status last verified
- Jan 2023
- First submitted
- 30 Dec 2022
- Last updated
- 9 Jan 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 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Mobile-based Multidomain Intervention to Improve Cognitive Function and Health-related Outcomes Among Older Korean Adults With a High Risk of Dementia
- ClinicalTrials.gov ID
- NCT05675137
- Acronym / sponsor ID
- 2022-03-013
- Conditions
- Cognitive Decline, Cognitive Impairment, Mild, Aging, Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Silvia HealthIndustry (pharma, biotech, devices)
- Collaborators
- Chosun University Hospital
- Study start
- 10 Apr 2022 (actual)
- Primary completion
- 28 Oct 2022 (actual)
- Study completion
- 28 Oct 2022 (actual)
- First posted
- 9 Jan 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 investigated the efficacy of the Silvia program, a mobile-based multidomain intervention, to improve cognitive function and health-related outcomes of older adults with a high risk of dementia. We compare its effects to a conventional paper-based multidomain program on various health indicators related to risk factors of dementia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile-based multidomain intervention | Experimental | Device: mobile-based |
| paper-based intervention group | Active comparator | Other: paper-based |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- experiencing subjective cognitive decline,
- had a smart phone and could use it, and
- understood the purpose and process of this study.
Key exclusion criteria (8 listed)
- major psychiatric disorders
- dementia,
- degenerative brain diseases
- severe or unstable heart diseases
- neurological or psychological diseases that affected cognitive functioning
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 |
|---|---|---|
| mobile-basedParticipants who were randomly assigned to the mobile-based intervention group were provided multidomain programs based on scientific evidence of ways to improve brain-health and reduce dementia risk for 10 minutes per day and at least 50 minutes per week. | Device | Mobile-based multidomain intervention |
| paper-basedParticipants who were randomly assigned to the paper-based intervention group were provided with the Korean version of the dementia prevention booklet published by the WHO. | Other | paper-based intervention group |
Primary outcome
Change from baseline Korean version of the Repeatable Battery for the Assessment of Neuropsychological status at 12 weeks
Time frame: baseline and after the 12-week intervention
Cognitive function
6 secondary outcomes
Change from baseline Korean version of the mini-mental state examination, 2nd edition(K-MMSE-2) at 12 weeks
Time frame: baseline and after the 12-week intervention
Change form baseline Korean version of the prospective and retrospective memory questionnaire(K-PRMQ) at 12 weeks
Time frame: baseline and after the 12-week intervention
Change from baseline Center for Epidemiological Studies Depression (CES-D) questionnaire at 12 weeks
Time frame: baseline and after the 12-week intervention
Change from baseline State-Trait Anxiety Inventory-X-1(STAI-X-1) at 12 weeks
Time frame: baseline and after the 12-week intervention
Change from baseline Perceived Stress Scale (PSS) at 12 weeks
Time frame: baseline and after the 12-week intervention
Change from baseline EuroQoL 5-Dimension 5-Level(EQ-5D-5L) at 12 weeks
Time frame: baseline and after the 12-week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobile-based and paper-based in people with Cognitive Decline and Cognitive Impairment, Mild, run by Silvia Health at 1 site in South Korea.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Korean version of the Repeatable Battery for the Assessment of Neuropsychological status at 12 weeks (time frame: baseline and after the 12-week intervention). 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 Jan 2023.