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

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 Overview

• Status: Completed
• Conditions: Dementia; Aging; Cognitive Decline; Cognitive Impairment, Mild
• Intervention / Treatment: Device: mobile-based; Other: paper-based

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Silviahealth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mobile-based multidomain intervention	Device: mobile-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.
Active Comparator: paper-based intervention group	Other: paper-based; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Silvia Health
• Collaborators: Chosun University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2022
• Primary Completion (Actual): October 28, 2022
• Study Completion (Actual): October 28, 2022

Study Registration Dates

• First Submitted: December 30, 2022
• First Submitted That Met QC Criteria: January 5, 2023
• First Posted (Estimate): January 9, 2023

Study Record Updates

• Last Update Posted (Estimate): January 9, 2023
• Last Update Submitted That Met QC Criteria: January 5, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Cognition Disorders; Dementia; Cognitive Dysfunction
• Other Study ID Numbers: 2022-03-013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No