UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039808
Receipt number R000045368
Scientific Title Research on system development for integrating medical information with life-log information of atopic dermatitis patients and applying it to medical care
Date of disclosure of the study information 2020/03/15
Last modified on 2020/12/04 15:04:55

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Basic information

Public title

Research to establish a system to utilize life-log information of patients with atopic dermatitis for medical treatment

Acronym

Skin-diary cloud research for atopic dermatitis patients

Scientific Title

Research on system development for integrating medical information with life-log information of atopic dermatitis patients and applying it to medical care

Scientific Title:Acronym

Clinical application study of life-log information of patients with atopic dermatitis

Region

Japan


Condition

Condition

Atopic dermatitis

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1


Using the smartphone application "Skin Diary Cloud", we will build a personalized analysis method for life log data, and establish a patient / medical viewer.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Input history and data to Skin-diary app

Key secondary outcomes

Evaluation of usability by questionnaire after implementation


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

Other

Interventions/Control_1

As a rule, use the skin diary app daily for one year

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

16 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who have their own smartphone and go to the atopy outpatient clinic at Keio University Hospital. The patients do not meet the following exclusion criteria. The nature of treatment and the degree of symptoms are not involved in patient selection.

Key exclusion criteria

1) Patients who cannot use smartphone.
2) Patients who are judged to be difficult to cooperate with this study by the investigator or the doctor based on past visits to the hospital.
3) Those who do not have a smartphone running on the OS that guarantees the operation of the skin diary app. (iOS11.0 or higher / Android6.0 or higher)

Target sample size

120


Research contact person

Name of lead principal investigator

1st name Keishi
Middle name
Last name Tanese

Organization

Keio University School of Medicine

Division name

Dermatology department

Zip code

1608582

Address

35 Shinanomachi Shinjuku-ku, Tokyo

TEL

03-3353-1211

Email

tanese@keio.jp


Public contact

Name of contact person

1st name HIroshi
Middle name
Last name Kawasaki

Organization

Keio University School of Medicine

Division name

Dermatology department

Zip code

160-8582

Address

35 Shinanomachi Shinjuku-ku, Tokyo

TEL

03-3353-1211

Homepage URL


Email

hiroshi.z5@keio.jp


Sponsor or person

Institute

Keio University

Institute

Department

Personal name



Funding Source

Organization

Cabinet Office

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



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

Tel

03-3353-1211

Email

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

東京都


Other administrative information

Date of disclosure of the study information

2020 Year 03 Month 15 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

2019 Year 12 Month 10 Day

Date of IRB

2020 Year 03 Month 16 Day

Anticipated trial start date

2020 Year 04 Month 01 Day

Last follow-up date

2021 Year 07 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 03 Month 13 Day

Last modified on

2020 Year 12 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045368


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name