Clinical trial NCT03494699: App-based Cognitive Training at Home
Official title: Effects of App-based Cognitive Training on Cognition in Community Dwelling Elderly Using: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Volunteers, Aged
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Gangnam Community Health Center
name: Gangnam-gu Center for Dementia
First posted: 2018-04-11
Enrollment: 400
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Change from Baseline Cognition at 6 month
timeFrame: Baseline, 6months
measure: Change from Baseline Cognition at 1 year
timeFrame: Baseline, 1year
Secondary outcomes:
measure: Change in Quality of life measures
timeFrame: Baseline, 6months, 1year
measure: Change in Depression
timeFrame: Baseline, 6months, 1year
measure: Change in anxiety
timeFrame: Baseline, 6months, 1year
measure: Change in Stress
timeFrame: Baseline, 6months, 1year
measure: Change in Subjective memory
timeFrame: Baseline, 6months, 1year
measure: Change in Activities of Daily Living
timeFrame: Baseline, 6months, 1year
measure: Change in Dementia Screening Questionnaire score
timeFrame: Baseline, 6months, 1year
measure: Change in Prospective and retrospective memory
timeFrame: Baseline, 6months, 1year
measure: Change in Mastery
timeFrame: Baseline, 6months, 1year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Dementia Center
Study officials:
References: