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App-based Cognitive Training at Home (ACTH)

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ClinicalTrials.gov Identifier: NCT03494699
Recruitment Status : Unknown
Verified February 2018 by Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : April 11, 2018
Last Update Posted : January 30, 2019
Sponsor:
Collaborators:
Gangnam Community Health Center
Gangnam-gu Center for Dementia
Information provided by (Responsible Party):
Samsung Medical Center

Tracking Information
First Submitted Date  ICMJE February 13, 2018
First Posted Date  ICMJE April 11, 2018
Last Update Posted Date January 30, 2019
Actual Study Start Date  ICMJE March 22, 2018
Estimated Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2018)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2018)
  • Change in Quality of life measures [ Time Frame: Baseline, 6months, 1year ]
    Quality of life questionnaire
  • Change in Depression [ Time Frame: Baseline, 6months, 1year ]
    Geriatric depression scale
  • Change in anxiety [ Time Frame: Baseline, 6months, 1year ]
    Geriatric Anxiety Inventory
  • Change in Stress [ Time Frame: Baseline, 6months, 1year ]
    Korean version of recognized stress scale
  • Change in Subjective memory [ Time Frame: Baseline, 6months, 1year ]
    Multifactorial Memory Questionaire
  • Change in Activities of Daily Living [ Time Frame: Baseline, 6months, 1year ]
    Korean version of Bayer ADL (Bayer Activities of Daily Living)
  • Change in Dementia Screening Questionnaire score [ Time Frame: Baseline, 6months, 1year ]
    Korean Dementia Screening Questionnaire
  • Change in Prospective and retrospective memory [ Time Frame: Baseline, 6months, 1year ]
    Prospective and retrospective memory questionnaire
  • Change in Mastery [ Time Frame: Baseline, 6months, 1year ]
    Mastery questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE App-based Cognitive Training at Home
Official Title  ICMJE Effects of App-based Cognitive Training on Cognition in Community Dwelling Elderly Using: A Randomized Controlled Trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Healthy Volunteers, Aged
Intervention  ICMJE Behavioral: Multidisciplinary prevention
group cognitive training (every month) App-based Cognitive Training at Home (using smartphone application) physical activity/body weight/smoking & alcohol cessation monitoring and feedback
Study Arms  ICMJE
  • Experimental: Intervention group
    Intervention: Behavioral: Multidisciplinary prevention
  • No Intervention: Control group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 4, 2018)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2019
Estimated Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03494699
Other Study ID Numbers  ICMJE 2018-02-050
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Samsung Medical Center
Study Sponsor  ICMJE Samsung Medical Center
Collaborators  ICMJE
  • Gangnam Community Health Center
  • Gangnam-gu Center for Dementia
Investigators  ICMJE Not Provided
PRS Account Samsung Medical Center
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP