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Clinical Trials/NCT03494699
NCT03494699
Unknown
Not Applicable

Effects of App-based Cognitive Training on Cognition in Community Dwelling Elderly Using: A Randomized Controlled Trial

Samsung Medical Center1 site in 1 country400 target enrollmentMarch 22, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy Volunteers, Aged
Sponsor
Samsung Medical Center
Enrollment
400
Locations
1
Primary Endpoint
Change from Baseline Cognition at 6 month
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 22, 2018
End Date
December 1, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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)

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

Outcomes

Primary Outcomes

Change from Baseline Cognition at 6 month

Time Frame: Baseline, 6months

Table-based cognitive screening test score

Change from Baseline Cognition at 1 year

Time Frame: Baseline, 1year

Table-based cognitive screening test score

Secondary Outcomes

  • Change in Depression(Baseline, 6months, 1year)
  • Change in Quality of life measures(Baseline, 6months, 1year)
  • Change in Stress(Baseline, 6months, 1year)
  • Change in Prospective and retrospective memory(Baseline, 6months, 1year)
  • Change in Activities of Daily Living(Baseline, 6months, 1year)
  • Change in Dementia Screening Questionnaire score(Baseline, 6months, 1year)
  • Change in anxiety(Baseline, 6months, 1year)
  • Change in Subjective memory(Baseline, 6months, 1year)
  • Change in Mastery(Baseline, 6months, 1year)

Study Sites (1)

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