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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

Primary Purpose

Cognitive Decline, Cognitive Impairment, Mild, Aging

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
mobile-based
paper-based
Sponsored by
Silvia Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cognitive Decline

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Silviahealth

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mobile-based multidomain intervention

paper-based intervention group

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline Korean version of the Repeatable Battery for the Assessment of Neuropsychological status at 12 weeks
Cognitive function

Secondary Outcome Measures

Change from baseline Korean version of the mini-mental state examination, 2nd edition(K-MMSE-2) at 12 weeks
Cognitive function
Change form baseline Korean version of the prospective and retrospective memory questionnaire(K-PRMQ) at 12 weeks
Self-reported memory failures
Change from baseline Center for Epidemiological Studies Depression (CES-D) questionnaire at 12 weeks
Depression
Change from baseline State-Trait Anxiety Inventory-X-1(STAI-X-1) at 12 weeks
Anxiety
Change from baseline Perceived Stress Scale (PSS) at 12 weeks
Stress
Change from baseline EuroQoL 5-Dimension 5-Level(EQ-5D-5L) at 12 weeks
Health-related Quality of life

Full Information

First Posted
December 30, 2022
Last Updated
January 5, 2023
Sponsor
Silvia Health
Collaborators
Chosun University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05675137
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
April 10, 2022 (Actual)
Primary Completion Date
October 28, 2022 (Actual)
Study Completion Date
October 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Silvia Health
Collaborators
Chosun University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Decline, Cognitive Impairment, Mild, Aging, Dementia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mobile-based multidomain intervention
Arm Type
Experimental
Arm Title
paper-based intervention group
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
mobile-based
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
paper-based
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline Korean version of the Repeatable Battery for the Assessment of Neuropsychological status at 12 weeks
Description
Cognitive function
Time Frame
baseline and after the 12-week intervention
Secondary Outcome Measure Information:
Title
Change from baseline Korean version of the mini-mental state examination, 2nd edition(K-MMSE-2) at 12 weeks
Description
Cognitive function
Time Frame
baseline and after the 12-week intervention
Title
Change form baseline Korean version of the prospective and retrospective memory questionnaire(K-PRMQ) at 12 weeks
Description
Self-reported memory failures
Time Frame
baseline and after the 12-week intervention
Title
Change from baseline Center for Epidemiological Studies Depression (CES-D) questionnaire at 12 weeks
Description
Depression
Time Frame
baseline and after the 12-week intervention
Title
Change from baseline State-Trait Anxiety Inventory-X-1(STAI-X-1) at 12 weeks
Description
Anxiety
Time Frame
baseline and after the 12-week intervention
Title
Change from baseline Perceived Stress Scale (PSS) at 12 weeks
Description
Stress
Time Frame
baseline and after the 12-week intervention
Title
Change from baseline EuroQoL 5-Dimension 5-Level(EQ-5D-5L) at 12 weeks
Description
Health-related Quality of life
Time Frame
baseline and after the 12-week intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Silviahealth
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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