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

• Sponsor: Silvia Health (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05675137
• Collaborator: Chosun University Hospital (Other)
• Enrollment: 80
• Location: 1
• Arms: 2
• Actual Duration (Months): 6.6
• Patients Per Site Per Month: 12.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cognitive Decline; Cognitive Impairment, Mild; Aging; Dementia	Device: mobile-based; Other: paper-based	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: Apr 10, 2022
• Actual Primary Completion Date: Oct 28, 2022
• Actual Study Completion Date: Oct 28, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

3. Change from baseline Center for Epidemiological Studies Depression (CES-D) questionnaire at 12 weeks [baseline and after the 12-week intervention]

   Depression

4. Change from baseline State-Trait Anxiety Inventory-X-1(STAI-X-1) at 12 weeks [baseline and after the 12-week intervention]

   Anxiety

5. Change from baseline Perceived Stress Scale (PSS) at 12 weeks [baseline and after the 12-week intervention]

   Stress

6. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Silviahealth	Seoul		Korea, Republic of

Sponsors and Collaborators

• Silvia Health
• Chosun University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Silvia Health
• ClinicalTrials.gov Identifier: NCT05675137
• Other Study ID Numbers: 2022-03-013
• First Posted: Jan 9, 2023
• Last Update Posted: Jan 9, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dementia; Cognitive Dysfunction

Study Results

No Results Posted as of Jan 9, 2023