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App-based Cognitive Training at Home (ACTH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers, Aged Behavioral: Multidisciplinary prevention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of App-based Cognitive Training on Cognition in Community Dwelling Elderly Using: A Randomized Controlled Trial
Actual Study Start Date : March 22, 2018
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : December 1, 2019

Arm Intervention/treatment
Experimental: Intervention group 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

No Intervention: Control group



Primary Outcome Measures :
  1. Change from Baseline Cognition at 6 month [ Time Frame: Baseline, 6months ]
    Table-based cognitive screening test score

  2. Change from Baseline Cognition at 1 year [ Time Frame: Baseline, 1year ]
    Table-based cognitive screening test score


Secondary Outcome Measures :
  1. Change in Quality of life measures [ Time Frame: Baseline, 6months, 1year ]
    Quality of life questionnaire

  2. Change in Depression [ Time Frame: Baseline, 6months, 1year ]
    Geriatric depression scale

  3. Change in anxiety [ Time Frame: Baseline, 6months, 1year ]
    Geriatric Anxiety Inventory

  4. Change in Stress [ Time Frame: Baseline, 6months, 1year ]
    Korean version of recognized stress scale

  5. Change in Subjective memory [ Time Frame: Baseline, 6months, 1year ]
    Multifactorial Memory Questionaire

  6. Change in Activities of Daily Living [ Time Frame: Baseline, 6months, 1year ]
    Korean version of Bayer ADL (Bayer Activities of Daily Living)

  7. Change in Dementia Screening Questionnaire score [ Time Frame: Baseline, 6months, 1year ]
    Korean Dementia Screening Questionnaire

  8. Change in Prospective and retrospective memory [ Time Frame: Baseline, 6months, 1year ]
    Prospective and retrospective memory questionnaire

  9. Change in Mastery [ Time Frame: Baseline, 6months, 1year ]
    Mastery questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494699


Contacts
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Contact: Duk L. Na, MD.PhD. 82234102378 dl1018.na@samsung.com
Contact: Hyemin Jang, MD 821063282876 hmjang57@gmail.com

Locations
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Korea, Republic of
Gangnam Dementia Center Recruiting
Seoul, Korea, Republic of
Contact: Hyemin Jang, Dr    82-70-7715-2025    gangnam1819@gmail.com   
Sponsors and Collaborators
Samsung Medical Center
Gangnam Community Health Center
Gangnam-gu Center for Dementia
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Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03494699    
Other Study ID Numbers: 2018-02-050
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No