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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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05675137
Enrollment
80
Registered
2023-01-09
Start date
2022-04-10
Completion date
2022-10-28
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Cognitive Decline, Cognitive Impairment, Mild, Dementia

Brief 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. We compare its effects to a conventional paper-based multidomain program on various health indicators related to risk factors of dementia.

Interventions

DEVICEmobile-based

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.

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.

Sponsors

Chosun University Hospital
CollaboratorOTHER
Silvia Health
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1. experiencing subjective cognitive decline, 2. had a smart phone and could use it, and 3. understood the purpose and process of this study.

Exclusion criteria

1. major psychiatric disorders 2. dementia, 3. degenerative brain diseases 4. severe or unstable heart diseases 5. neurological or psychological diseases that affected cognitive functioning 6. severe vision or hearing impairment, 7. current participation in a cognitive training program 8. does not know how to use mobile devices.

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline Korean version of the Repeatable Battery for the Assessment of Neuropsychological status at 12 weeksbaseline and after the 12-week interventionCognitive function

Secondary

MeasureTime frameDescription
Change form baseline Korean version of the prospective and retrospective memory questionnaire(K-PRMQ) at 12 weeksbaseline and after the 12-week interventionSelf-reported memory failures
Change from baseline Center for Epidemiological Studies Depression (CES-D) questionnaire at 12 weeksbaseline and after the 12-week interventionDepression
Change from baseline Korean version of the mini-mental state examination, 2nd edition(K-MMSE-2) at 12 weeksbaseline and after the 12-week interventionCognitive function
Change from baseline Perceived Stress Scale (PSS) at 12 weeksbaseline and after the 12-week interventionStress
Change from baseline EuroQoL 5-Dimension 5-Level(EQ-5D-5L) at 12 weeksbaseline and after the 12-week interventionHealth-related Quality of life
Change from baseline State-Trait Anxiety Inventory-X-1(STAI-X-1) at 12 weeksbaseline and after the 12-week interventionAnxiety

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026