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

NCT05675137 | Completed DMC

• 1 other identifier: 2022-03-013
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Decline; Cognitive Impairment, Mild; Aging; Dementia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

• Change form baseline Korean version of the prospective and retrospective memory questionnaire(K-PRMQ) at 12 weeks

  baseline and after the 12-week intervention

• Change from baseline Center for Epidemiological Studies Depression (CES-D) questionnaire at 12 weeks

  baseline and after the 12-week intervention

• Change from baseline State-Trait Anxiety Inventory-X-1(STAI-X-1) at 12 weeks

  baseline and after the 12-week intervention

• Change from baseline Perceived Stress Scale (PSS) at 12 weeks

  baseline and after the 12-week intervention

Study Arms (2)

Mobile-based multidomain intervention

EXPERIMENTAL

Device: mobile-based

paper-based intervention group

ACTIVE COMPARATOR

Other: paper-based

Interventions

mobile-based DEVICE

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.

Mobile-based multidomain intervention

paper-based OTHER

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.

paper-based intervention group

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Silvia Health: lead
• Chosun University Hospital: collaborator

Study Sites (1)

Silviahealth

Seoul, South Korea

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2022
• First Posted: January 9, 2023
• Study Start: April 10, 2022
• Primary Completion: October 28, 2022
• Study Completion: October 28, 2022
• Last Updated: January 9, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)