App-based Cognitive Training at Home (ACTH)

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

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.

Study Overview

• Status: Unknown
• Conditions: Healthy Volunteers, Aged
• Intervention / Treatment: Behavioral: Multidisciplinary prevention

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Gangnam Dementia Center
    • Contact: Hyemin Jang, Dr; Phone Number: 82-70-7715-2025; Email: gangnam1819@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Cognition at 6 month	Table-based cognitive screening test score	Baseline, 6months
Change from Baseline Cognition at 1 year	Table-based cognitive screening test score	Baseline, 1year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Collaborators: Gangnam Community Health Center; Gangnam-gu Center for Dementia

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2018
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: February 13, 2018
• First Submitted That Met QC Criteria: April 4, 2018
• First Posted (Actual): April 11, 2018

Study Record Updates

• Last Update Posted (Actual): January 30, 2019
• Last Update Submitted That Met QC Criteria: January 27, 2019
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 2018-02-050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No