Healthy Volunteers, AgedACTHNCT03494699
App-based Cognitive Training at Home
A study testing Multidisciplinary prevention in people with Healthy Volunteers, Aged, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Aged
- What is being tested?
- Multidisciplinary prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Mar 2018to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Gangnam Dementia Center
Seoul
Hyemin Jang, Dr, 82-70-7715-2025, gangnam1819@gmail.com
About this study
Official 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.
- Conditions
- Healthy Volunteers, Aged
- Being tested
- Multidisciplinary prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary preventionBehavioural
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 group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Behavioral: Multidisciplinary prevention |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Cognition at 6 month
Table-based cognitive screening test score
Measured: Baseline, 6months
Change from Baseline Cognition at 1 year
Table-based cognitive screening test score
Measured: Baseline, 1year
Secondary outcomes (9)
Change in Quality of life measures
Quality of life questionnaire
Measured: Baseline, 6months, 1year
Change in Depression
Geriatric depression scale
Measured: Baseline, 6months, 1year
Change in anxiety
Geriatric Anxiety Inventory
Measured: Baseline, 6months, 1year
Change in Stress
Korean version of recognized stress scale
Measured: Baseline, 6months, 1year
Change in Subjective memory
Multifactorial Memory Questionaire
Measured: Baseline, 6months, 1year
Change in Activities of Daily Living
Korean version of Bayer ADL (Bayer Activities of Daily Living)
Measured: Baseline, 6months, 1year
Change in Dementia Screening Questionnaire score
Korean Dementia Screening Questionnaire
Measured: Baseline, 6months, 1year
Change in Prospective and retrospective memory
Prospective and retrospective memory questionnaire
Measured: Baseline, 6months, 1year
Change in Mastery
Mastery questionnaire
Measured: Baseline, 6months, 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start22 Mar 2018
- Primary completion1 Oct 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers, AgedStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Gangnam Community Health Center, Gangnam-gu Center for Dementia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03494699
- Sponsor's protocol ID
- 2018-02-050
- Acronym
- ACTH
- Status last verified
- Feb 2018
- First submitted
- 13 Feb 2018
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of App-based Cognitive Training on Cognition in Community Dwelling Elderly Using: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03494699
- Acronym / sponsor ID
- ACTH / 2018-02-050
- Conditions
- Healthy Volunteers, Aged
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Gangnam Community Health Center, Gangnam-gu Center for Dementia
- Study start
- 22 Mar 2018 (actual)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 11 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Multidisciplinary prevention |
| Control group | No intervention | – |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- literate
- education years >= 6 years
- not demented
- mini-mental status examination >= 24
- android cellular phone users
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidisciplinary preventiongroup cognitive training (every month) App-based Cognitive Training at Home (using smartphone application) physical activity/body weight/smoking \& alcohol cessation monitoring and feedback | Behavioural | Intervention group |
Primary outcome
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
9 secondary outcomes
Change in Quality of life measures
Time frame: Baseline, 6months, 1year
Change in Depression
Time frame: Baseline, 6months, 1year
Change in anxiety
Time frame: Baseline, 6months, 1year
Change in Stress
Time frame: Baseline, 6months, 1year
Change in Subjective memory
Time frame: Baseline, 6months, 1year
Change in Activities of Daily Living
Time frame: Baseline, 6months, 1year
Change in Dementia Screening Questionnaire score
Time frame: Baseline, 6months, 1year
Change in Prospective and retrospective memory
Time frame: Baseline, 6months, 1year
Change in Mastery
Time frame: Baseline, 6months, 1year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Individual participant dataSharing planned: No
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Healthy Volunteers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidisciplinary prevention in people with Healthy Volunteers, Aged, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Duk L. Na, MD.PhD. (82234102378, dl1018.na@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Cognition at 6 month (time frame: Baseline, 6months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2019.