UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047890 |
|---|---|
| Receipt number | R000050704 |
| Scientific Title | Development of a telepsychological service to maximize the quality of life for patients with epilepsy |
| Date of disclosure of the study information | 2022/06/03 |
| Last modified on | 2022/06/03 13:53:48 |
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Basic information
Public title
Development of a telepsychological service to maximize the quality of life for patients with epilepsy
Acronym
Development of a telepsychological service to maximize the quality of life for patients with epilepsy
Scientific Title
Development of a telepsychological service to maximize the quality of life for patients with epilepsy
Scientific Title:Acronym
Development of a telepsychological service to maximize the quality of life for patients with epilepsy
Region
| Japan |
Condition
Condition
epilepsy
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of a telepsychological service to maximize the quality of life for patients with epilepsy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time: post 1-month and 1-year
Outcomes: seizure-related factors, QOL, Depression
Key secondary outcomes
self-stigma
acceptance of disability
social support
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Psychological interview
Interventions/Control_2
Telepsychology services
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria as follows: admission to the Epilepsy Monitoring Unit for diagnostic and presurgical evaluation; diagnosis of epilepsy; age 20 years or older; ability to answer the self-reported questionnaire; and informed consent on the study.
Key exclusion criteria
Excluded criteria as follows: patients who were younger than 20 years, had incomplete self-reported questionnaires due to lack of understanding or Japanese language fluency, had missing values invariables used for the analysis, and did not consent to the participation of the study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Nobukazu |
| Middle name | |
| Last name | Nakasato |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Epileptology
Zip code
980-8575
Address
2-1 Seiryo-mach, Aoba-ku, Sendai, Japan
TEL
0227177343
nkst@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Maimi |
| Middle name | |
| Last name | Ogawa |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Epileptology
Zip code
980-8575
Address
2-1 Seiryo-mach, Aoba-ku, Sendai, Japan
TEL
0227177343
Homepage URL
maimi.ogawa.a7@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Tohoku University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-mach, Aoba-ku, Sendai, Japan
Tel
0227177343
maimi.ogawa.a7@tohoku.ac.jp
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
| 2022 | Year | 06 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 06 | Month | 03 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 19 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 05 | Month | 30 | Day |
Last modified on
| 2022 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050704
