App-based Cognitive Training at Home

Not Applicable

• Conditions: Healthy Volunteers, Aged
• Interventions: Behavioral: Multidisciplinary prevention

• Registration Number: NCT03494699
• Lead Sponsor: Samsung Medical Center

Brief Summary

This randomized controlled trial is for investigating the effects of multidisciplinary intervention program on cognition and activity of daily living ability in community dwelling healthy elderly. The intervention consists of cognitive group training every month, daily home cognitive training using cognitive training smartphone application, record of weekly physical activity and body weight and feedback program, and alcohol and smoking cessation monitoring and feedback program. Among these interventions, app-based cognitive training at home is the major intervention in this study. The total duration of intervention is 1 year, and the tablet-based cognitive screening test and the patient-reported questionnaires to evaluate subjective memory decline, quality of life, depression, and activity of daily living are used for outcome measures.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2018-02
• Study First Submitted: 2018-02-13
• Study Start: 2018-03-22
• Study First Submitted QC: 2018-04-04
• Study First Posted: 2018-04-11
• Last Update Submitted: 2019-01-27
• Last Update Posted: 2019-01-30
• Primary Completion: 2019-10-01
• Study Completion: 2019-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• literate
• education years >= 6 years
• not demented
• mini-mental status examination >= 24
• android cellular phone users
• no significant decline in activities of daily living (Korea- Instrumental Activities of Daily Living =<5)

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Exclusion Criteria

• Who has a history of major cardiovascular diseases within 3 months of study enrollment (ex. myocardial infarction, stroke)
• Who has current illnesses that could possibly affect cognition or with anticipated life expectancy of less than 2 years (ex. end stage cancer, on chemotherapy)
• Who has a severe hearing difficulty or visual disturbance
• Who has a limitation in communication
• Who was diagnosed with dementia
• Who has a plan for immigration or move in 1.5 years after study enrollment
• Who underwent a cognitive training within 6 months of study enrollment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Multidisciplinary prevention	-

Primary Outcome Measures

Name	Time	Method
Change from Baseline Cognition at 6 month	Baseline, 6months	Table-based cognitive screening test score
Change from Baseline Cognition at 1 year	Baseline, 1year	Table-based cognitive screening test score

Secondary Outcome Measures

Name	Time	Method
Change in Depression	Baseline, 6months, 1year	Geriatric depression scale
Change in Quality of life measures	Baseline, 6months, 1year	Quality of life questionnaire
Change in Stress	Baseline, 6months, 1year	Korean version of recognized stress scale
Change in Activities of Daily Living	Baseline, 6months, 1year	Korean version of Bayer ADL (Bayer Activities of Daily Living)
Change in Dementia Screening Questionnaire score	Baseline, 6months, 1year	Korean Dementia Screening Questionnaire
Change in anxiety	Baseline, 6months, 1year	Geriatric Anxiety Inventory
Change in Subjective memory	Baseline, 6months, 1year	Multifactorial Memory Questionaire
Change in Mastery	Baseline, 6months, 1year	Mastery questionnaire
Change in Prospective and retrospective memory	Baseline, 6months, 1year	Prospective and retrospective memory questionnaire

Trial Locations

Locations (1)

Gangnam Dementia Center; 🇰🇷 Seoul, Korea, Republic of