UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050076 |
|---|---|
| Receipt number | R000056958 |
| Scientific Title | Demonstration experiment on improving communication with patients using ePRO in atopic dermatitis |
| Date of disclosure of the study information | 2023/01/25 |
| Last modified on | 2024/02/05 15:57:52 |
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Basic information
Public title
Demonstration experiment on improving communication with patients using ePRO in atopic dermatitis
Acronym
Demonstration experiment on improving communication with patients using ePRO in atopic dermatitis
Scientific Title
Demonstration experiment on improving communication with patients using ePRO in atopic dermatitis
Scientific Title:Acronym
Demonstration experiment on improving communication with patients using ePRO in atopic dermatitis
Region
| Japan |
Condition
Condition
Atopic dermatitis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will examine the feasibility of using ePRO for disease management of atopic dermatitis patients to activate communication between patients and doctors, increase patient satisfaction with treatment, and improve treatment effects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patients' satisfaction and challenges with using ePRO will be assessed using patient questionnaires at the beginning and after 8 weeks.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The ePRO system uses Integrity Healthcare's YaDoc. After obtaining consent for participation in this study from the research subject patient, install the application on the smartphone owned by the research subject according to the YaDoc operation manual. The research subjects are at home during the treatment days, and periodically, once a week, use YaDoc to answer medical questions and record symptoms. POEM and ADCT, which are self-assessment tools for atopic dermatitis, are used for interviews and symptom records. For pruritus, respond using the pruritus NRS (Numerical Rating Scale) to answer the mean of pruritus for a week on an 11-point scale from 0 (no pruritus) to 10 (unbearable pruritus). Optionally, and if possible, record exacerbations using YaDoc's photography function. The recording period shall be 8 weeks. Before the start and at the end of the study, a questionnaire survey will be conducted on the research subjects to examine the usefulness of medical care using ePRO.
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1 Patients with atopic dermatitis who are 18 years of age or older at the time of informed consent
2 Patients judged by the investigator that patient data collection by ePRO is effective
3 Smartphone (iOS, Android) users
Key exclusion criteria
1 Cases where it is difficult to see, operate, and understand YaDoc and smartphones
2 Patients participating in a clinical study with other interventions at the start of this study
3 Other patients who are judged by doctors to be unfavorable subjects
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Motoi |
| Middle name | |
| Last name | Takenaka |
Organization
Nagasaki University Hospital
Division name
Dermatology and Allergology
Zip code
8528501
Address
1-7-1 sakamoto, Nagasaki-city
TEL
0958197200
m-take@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Motoi |
| Middle name | |
| Last name | Takenaka |
Organization
Nagasaki University Hospital
Division name
Dermatology and Allergology
Zip code
8528501
Address
1-7-1 sakamoto, Nagasaki-city
TEL
0958197200
Homepage URL
m-take@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital Clinical Research Ethics Committee
Address
1-7-1 sakamoto, Nagasaki-city
Tel
0958192503
gaibushikin@ml.nagasaki-u.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
| 2023 | Year | 01 | Month | 25 | 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
Completed
Date of protocol fixation
| 2023 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 08 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 18 | Day |
Last modified on
| 2024 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056958
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
