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

Not Applicable

Completed

• Conditions: Dementia; Cognitive Decline; Cognitive Impairment, Mild; Aging
• Interventions: Device: mobile-based; Other: paper-based

• Registration Number: NCT05675137
• Lead Sponsor: Silvia Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-10
• Primary Completion: 2022-10-28
• Study Completion: 2022-10-28
• Study First Submitted: 2022-12-30
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-05
• Last Update Submitted: 2023-01-05
• Study First Posted: 2023-01-09
• Last Update Posted: 2023-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mobile-based multidomain intervention	mobile-based	-
paper-based intervention group	paper-based	-

Primary Outcome Measures

Name	Time	Method
Change from baseline Korean version of the Repeatable Battery for the Assessment of Neuropsychological status at 12 weeks	baseline and after the 12-week intervention	Cognitive function

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Silviahealth; 🇰🇷 Seoul, Korea, Republic of