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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cognitive Decline, Cognitive Impairment, Mild, Aging, Dementia

Intervention / Treatment
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* Device: mobile-based
* Other: paper-based


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: experiencing subjective cognitive decline, had a smart phone and could use it, and understood the purpose and process of this study. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile-based multidomain intervention<br> | Device: mobile-based<br>* 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.<br>|
| Active Comparator: paper-based intervention group<br> | Other: paper-based<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Korean version of the Repeatable Battery for the Assessment of Neuropsychological status at 12 weeks | Cognitive function | baseline and after the 12-week intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Korean version of the mini-mental state examination, 2nd edition(K-MMSE-2) at 12 weeks | Cognitive function | 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 | baseline and after the 12-week intervention | 
| Change from baseline Center for Epidemiological Studies Depression (CES-D) questionnaire at 12 weeks | Depression | baseline and after the 12-week intervention | 
| Change from baseline State-Trait Anxiety Inventory-X-1(STAI-X-1) at 12 weeks | Anxiety | baseline and after the 12-week intervention | 
| Change from baseline Perceived Stress Scale (PSS) at 12 weeks | Stress | 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 | baseline and after the 12-week intervention |