UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057034 |
|---|---|
| Receipt number | R000065189 |
| Scientific Title | Observational study on the use of ePRO (electronic patient reported outcomes) to assess depressive symptoms |
| Date of disclosure of the study information | 2025/02/14 |
| Last modified on | 2025/02/14 16:27:57 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Observational study on the use of ePRO (electronic patient reported outcomes) to assess depressive symptoms
Acronym
Observational study on the use of ePRO to assess depressive symptoms
Scientific Title
Observational study on the use of ePRO (electronic patient reported outcomes) to assess depressive symptoms
Scientific Title:Acronym
Observational study on the use of ePRO to assess depressive symptoms
Region
| Japan |
Condition
Condition
Depression, anxiety
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Currently, the usual method for measuring the mental symptoms of depression in patients is to assess their symptoms using a paper-based self-administered questionnaire, but this is difficult for patients and makes it difficult to objectively assess changes in their symptoms. Therefore, by using ePRO (electronic patient-reported outcomes) via smartphones and other devices, patients can enter their own symptom assessments, which reduces the burden on them and makes it possible for them to understand their own symptom changes. By enabling healthcare professionals to understand the content of the entries, it becomes possible to share information about the progress of symptoms. We aim to construct an outcome database by collecting and analyzing epidemiological data that makes it possible to understand changes in symptoms of depression and anxiety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient Health Questionnaire-9 (PHQ-9)
Generalized Anxiety Disorder -7 (GAD-7)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Persons aged 18 years or older
2) Patients with symptoms of depression or anxiety (due to the nature of the research, which involves the construction of a database for the voluntary registration of patients' subjective symptoms, the diagnosis will not be strictly limited to a narrow sense of the term, but will be broadly defined as depression or anxiety)
3) Persons who, after receiving sufficient written and verbal explanations regarding participation in this research, provide written consent through their own free will, with sufficient understanding
4) Those who can use information terminals such as smartphones and tablet PCs independently and who can continuously register data on the web by themselves for at least one year.
Key exclusion criteria
A person who the principal investigator or a sub-investigator deems unsuitable for conducting this study safely
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | eiji |
| Middle name | |
| Last name | shimizu |
Organization
Chiba University
Division name
Center for Cognitive Behavioral Therapy, Chiba University Hospital
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
043-222-7171
yoichi-seki@chiba-u.jp
Public contact
Name of contact person
| 1st name | yoichi |
| Middle name | |
| Last name | seki |
Organization
Chiba University
Division name
Research Center for Child Development
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
043-226-2975
Homepage URL
yoichi-seki@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Chiba University
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
Chiba University Hospital Clinical Trials Department
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
Tel
043-222-7171
hsp-kansaturinri@chiba-u.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
| 2025 | Year | 02 | Month | 14 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 07 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 13 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2025 | Year | 02 | Month | 14 | Day |
Last modified on
| 2025 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065189
