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出境医 / 临床实验 / Efficacy of the Cognitive Training Based on Location Information and Activity in People With Mild Cognitive Impairment
Efficacy of the Cognitive Training Based on Location Information and Activity in People With Mild Cognitive Impairment
Study Description
Brief Summary:
The purpose of this study is to examine therapeutic efficacy of cognitive Training based on location information and activity in people with mild cognitive impairment
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Mild Cognitive Impairment | Behavioral: tablet based Cognitive Training based on location information | Not Applicable |
Detailed Description:
- A single arm, open-label study.
- Cognitive Training based on location information and activity is consists of both cognitive training and exercise(walking) using objects in the participant's home. The researchers visit the participant's home and find objects that were mainly used in the real life and easy to access (table, computer, television, etc.) and attach the recognition Bluetooth Low Energy(BLE) Tag (sticker integrated). The stickers printed on the tags consist of word categories (eg animals) belonging to a particular category, so as to assist strategic recall in the stepped recall task. The participants follow the instruction from the tablet-based program to perform the task. During performing the cognitive training program, the participants are guided to walk between the tagged objects in their home.
- The participants are aged over 60 years old and diagnosed with mild cognitive impairment.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 43 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Efficacy of the Cognitive Training Based on Location Information and Activity in People With Mild Cognitive Impairment |
| Actual Study Start Date : | April 17, 2019 |
| Actual Primary Completion Date : | December 31, 2019 |
| Actual Study Completion Date : | February 28, 2020 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
Experimental: Mild Cognitive Impairment
|
Behavioral: tablet based Cognitive Training based on location information
Participants perform Tablet based Cognitive training using interactive voice services and tags three times (minimum 30 minutes per time) a week for 6 weeks
|
Outcome Measures
Primary Outcome Measures :
- Change in CERAD-TS1 score [ Time Frame: baseline and 6 weeks ]Total Score of the Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Neuropsychological Assessment Battery (CERAD-TS1) . CERAD-TS1 is generated by simply summing the scores of six tests including the 1) Verbal fluency (range 0-24), 2) Boston naming test (0-15), 3) Word List Memory (0-30), 4) Word List Recall (0-10), 5) Word list recognition (0-10), 6) Constructional Praxis (0-11). The range of CERAD-TS1 score is 0 to 100 points), and the higher score represents the better cognitive function.
Secondary Outcome Measures :
- Change in MMSE score [ Time Frame: baseline and 6 weeks ]Mini-Mental State Examination (MMSE), ranged 0-30, the higher score represents the better cognitive function
- Change in SMCQ score [ Time Frame: baseline and 6 weeks ]Subjective Memory Complaint Questionnaire (SMCQ), ranged 0-14, the higher score represents the more difficulties in memory function for everyday life
- Change in GDS score [ Time Frame: baseline and 6 weeks ]Geriatric depression scale (GDS), ranged 0-30, the higher score represents the more severe depressive symptoms
Eligibility Criteria
| Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Aged above 60
- Confirmed literacy o Diagnosed with mild cognitive impairment by International Working Group on Mild Cognitive Impairment and Clinical Dementia Rating(CDR) of 0 or 0.5.
Exclusion Criteria:
- Evidence of delirium, confusion
- Any neurological conditions causing cognitive decline such as Parkinson's disease, brain hemorrhage, brain tumor, normal pressure hydrocephalus
- Evidence of severe cerebrovascular pathology
- Presence of depressive symptoms that could influence cognitive function
- Presence of medical comorbidities that could result in any difficulties in study participation
Contacts and Locations
Locations
| Korea, Republic of | |
| Seoul National University Bundang Hospital, | |
| Seongnam-si, Gyeonggi, Korea, Republic of, 13620 | |
Sponsors and Collaborators
Seoul National University Bundang Hospital
Institute of Information & Communications Technology Planning & Evaluation, Korea
Investigators
| Principal Investigator: | Ji Won Han, M.D., Ph.D. | Seoul National University Bundang Hospital |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 24, 2019 | ||||
| First Posted Date ICMJE | April 26, 2019 | ||||
| Last Update Posted Date | March 18, 2020 | ||||
| Actual Study Start Date ICMJE | April 17, 2019 | ||||
| Actual Primary Completion Date | December 31, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Change in CERAD-TS1 score [ Time Frame: baseline and 6 weeks ] Total Score of the Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Neuropsychological Assessment Battery (CERAD-TS1) . CERAD-TS1 is generated by simply summing the scores of six tests including the 1) Verbal fluency (range 0-24), 2) Boston naming test (0-15), 3) Word List Memory (0-30), 4) Word List Recall (0-10), 5) Word list recognition (0-10), 6) Constructional Praxis (0-11). The range of CERAD-TS1 score is 0 to 100 points), and the higher score represents the better cognitive function.
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| Original Primary Outcome Measures ICMJE |
CERAD-Total Score (TS)1 [ Time Frame: 2 weeks ] CERAD-TS 1
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| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Efficacy of the Cognitive Training Based on Location Information and Activity in People With Mild Cognitive Impairment | ||||
| Official Title ICMJE | Efficacy of the Cognitive Training Based on Location Information and Activity in People With Mild Cognitive Impairment | ||||
| Brief Summary | The purpose of this study is to examine therapeutic efficacy of cognitive Training based on location information and activity in people with mild cognitive impairment | ||||
| Detailed Description |
|
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | Mild Cognitive Impairment | ||||
| Intervention ICMJE | Behavioral: tablet based Cognitive Training based on location information
Participants perform Tablet based Cognitive training using interactive voice services and tags three times (minimum 30 minutes per time) a week for 6 weeks
|
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| Study Arms ICMJE | Experimental: Mild Cognitive Impairment
Intervention: Behavioral: tablet based Cognitive Training based on location information
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
43 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | February 28, 2020 | ||||
| Actual Primary Completion Date | December 31, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 60 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Korea, Republic of | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03928613 | ||||
| Other Study ID Numbers ICMJE | B-1903-526-301 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Ji Won Han, Seoul National University Bundang Hospital | ||||
| Study Sponsor ICMJE | Seoul National University Bundang Hospital | ||||
| Collaborators ICMJE | Institute of Information & Communications Technology Planning & Evaluation, Korea | ||||
| Investigators ICMJE |
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| PRS Account | Seoul National University Bundang Hospital | ||||
| Verification Date | March 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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