Healthy Volunteers, Aged Clinical Trial
— ACTHOfficial title:
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.
| Status | Recruiting |
| Enrollment | 400 |
| Est. completion date | December 1, 2019 |
| Est. primary completion date | October 1, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 60 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Gangnam Dementia Center | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Samsung Medical Center | Gangnam-gu Center for Dementia, Gangnam-gu Community Health Center |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from Baseline Cognition at 6 month | Table-based cognitive screening test score | Baseline, 6months | |
| Primary | Change from Baseline Cognition at 1 year | Table-based cognitive screening test score | Baseline, 1year | |
| Secondary | Change in Quality of life measures | Quality of life questionnaire | Baseline, 6months, 1year | |
| Secondary | Change in Depression | Geriatric depression scale | Baseline, 6months, 1year | |
| Secondary | Change in anxiety | Geriatric Anxiety Inventory | Baseline, 6months, 1year | |
| Secondary | Change in Stress | Korean version of recognized stress scale | Baseline, 6months, 1year | |
| Secondary | Change in Subjective memory | Multifactorial Memory Questionaire | Baseline, 6months, 1year | |
| Secondary | Change in Activities of Daily Living | Korean version of Bayer ADL (Bayer Activities of Daily Living) | Baseline, 6months, 1year | |
| Secondary | Change in Dementia Screening Questionnaire score | Korean Dementia Screening Questionnaire | Baseline, 6months, 1year | |
| Secondary | Change in Prospective and retrospective memory | Prospective and retrospective memory questionnaire | Baseline, 6months, 1year | |
| Secondary | Change in Mastery | Mastery questionnaire | Baseline, 6months, 1year |