UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040890 |
|---|---|
| Receipt number | R000046686 |
| Scientific Title | Effectiveness and safety evaluation of online dementia medical care |
| Date of disclosure of the study information | 2020/06/25 |
| Last modified on | 2024/12/28 09:03:41 |
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Basic information
Public title
Effectiveness and safety evaluation of dementia medical care using online medical care
Acronym
Effectiveness and safety evaluation of dementia medical care using online medical care
Scientific Title
Effectiveness and safety evaluation of online dementia medical care
Scientific Title:Acronym
Effectiveness and safety evaluation of online dementia medical care
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Neurology | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluating the effectiveness and safety of online medical care for patients with dementia
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
The main endpoints in this study are measured at the start of the study (0 weeks), 24 weeks, and 48 weeks by the three-time evaluation Zarit care burden scale.
Key secondary outcomes
Cognitive function(MMSE), clinical dementia rating(CDR), questionnaire version Neuropsychiatric Inventory-Brief Questionnaire Form (NPI-Q), Geriatric depression scale 15 (GDS15) at the start of the study (0weeks), 24 weeks, 48weeks 3evaluations.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Face-to-face consultation period
Interventions/Control_2
online medical treatment combination period
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 50 | years-old | <= |
Age-upper limit
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who visit our memory clinic.
Patients with dementia or mild cognitive impairment between the ages of 50 and under 95.
Person who can determine that necessary inspection can be performed on the specified date after obtaining consent
Study partners have at least 7 hours of contact with the subject per week and can accompany all consultations during the observation period.
Person who obtained consent in writing from the research participant and study partner
Person who can use online medical care.
Key exclusion criteria
Person with a history of substance use disorder other than smoking or being treated
Person who has a history of epilepsy or is being treated
Persons receiving antidepressants, antipsychotics, hypnotics including long-term sleeping pills
Persons with a history of psychiatric/neurological disorders that affect cognitive function
Persons with serious complications
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Ito |
Organization
Keio University School of Medicine
Division name
Department of Neurology
Zip code
1608582
Address
Tokyo
TEL
0353633788
dito@keio.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Ito |
Organization
Keio University School of Medicine
Division name
Department of Neurology
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku,Tokyo 160-8582, Japan
TEL
0353633788
Homepage URL
dito@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku,Tokyo 160-8582, Japan
Tel
0333531211
keio@esct.bvits.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 25 | Day |
Related information
URL releasing protocol
https://keio-memory-clinic.com/
Publication of results
Unpublished
Result
URL related to results and publications
https://keio-memory-clinic.com/
Number of participants that the trial has enrolled
13
Results
The study is currently being analysed and published, but analysis was difficult due to drop-outs and discontinuations: 6 (2 withdrawals, 2 COVID infections at the date of assessment, 2 difficulties in attending our hospital from mid-course). No significant results were obtained and no publication is planned.
Results date posted
| 2024 | Year | 06 | Month | 28 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
The study is currently being analysed and published, but analysis was difficult due to drop-outs and discontinuations: 6 (2 withdrawals, 2 COVID infections at the date of assessment, 2 difficulties in attending our hospital from mid-course). No significant results were obtained and no publication is planned.
Date of the first journal publication of results
Baseline Characteristics
Among the patients who visit our memory clinic, those who are selected by the principal investigator, practising director and sub-director as appropriate for this study, satisfying all of the following conditions will be included.
Patients with dementia aged between 50 and 95 years (age at obtaining consent).
The study partner must be able to carry out the necessary tests on the specified date after consent is obtained.
Study partners must have contact with the subjects for at least 7 hours per week and be able to accompany them to all consultations during the observation period.
The study partner must be in contact with the subject for at least 7 hours per week and must be able to accompany the subject for all visits during the observation period.
Translated with DeepL.com (free version)
Participant flow
Patients attending our outpatient memory department for treatment of dementia are asked to cooperate in research during their outpatient visits.
Adverse events
non
Outcome measures
The primary endpoint in this study will be measured by the Zarit care burden scale assessed three times at the beginning of the study (0 weeks), 24 weeks and 48 weeks. A range of +-7 weeks from the scheduled assessment date will be allowed for the evaluation of the intervention period.
Plan to share IPD
N/A
IPD sharing Plan description
N/A
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 25 | Day |
Last modified on
| 2024 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046686
