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OpenTrials
Completed

NCT Number: NCT05675137

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.

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Key information

Conditions

Cognitive Decline Aging Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Cognitive Impairment, Mild Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Silviahealth

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Change from baseline Korean version of the Repeatable Battery for the Assessment of Neuropsychological status at 12 weeks

    Time frame: baseline and after the 12-week intervention

    Cognitive function

Secondary outcomes

  1. Change from baseline Korean version of the mini-mental state examination, 2nd edition(K-MMSE-2) at 12 weeks

    Time frame: 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

    Time frame: 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

    Time frame: baseline and after the 12-week intervention

    Depression

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

    Time frame: baseline and after the 12-week intervention

    Anxiety

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

    Time frame: baseline and after the 12-week intervention

    Stress

  6. Change from baseline EuroQoL 5-Dimension 5-Level(EQ-5D-5L) at 12 weeks

    Time frame: baseline and after the 12-week intervention

    Health-related Quality of life

Sponsors and collaborators

Lead sponsor

Silvia Health

Industry

Collaborators

  • Chosun University Hospital

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 9, 2023
Registry last updated
Jan 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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