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

Aging Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05675137
• Other study ID #: 2022-03-013
• Status: Completed
• Phase: N/A
• Start date: April 10, 2022
• Est. completion date: October 28, 2022

Study information

• Verified date: January 2023
• Source: Silvia Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 28, 2022
• Est. primary completion date: October 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• Cognitive Decline
• Cognitive Dysfunction
• Cognitive Impairment, Mild
• Dementia

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.

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.

Locations

Country	Name	City	State
Korea, Republic of	Silviahealth	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Silvia Health	Chosun University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Change from baseline Center for Epidemiological Studies Depression (CES-D) questionnaire at 12 weeks	Depression	baseline and after the 12-week intervention
Secondary	Change from baseline State-Trait Anxiety Inventory-X-1(STAI-X-1) at 12 weeks	Anxiety	baseline and after the 12-week intervention
Secondary	Change from baseline Perceived Stress Scale (PSS) at 12 weeks	Stress	baseline and after the 12-week intervention
Secondary	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