UMIN-CTR Clinical Trial

Public title

A cohort study on patient-reported outcomes (PRO) in patients with lifestyle disease who have used Welby My-Karte

Acronym

e-PROMIS

Scientific Title

A cohort study on patient-reported outcomes (PRO) in patients with lifestyle disease who have used Welby My-Karte

Scientific Title:Acronym

e-PROMIS

Region

Japan

Condition

Those with a lifestyle disease (diabetes, hypertension, or hyperlipidemia)

Classification by specialty

Medicine in general	Gastroenterology	Cardiology
Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The percentage of those who continue using Welby My-Karte (continuation rate), the distribution of the duration of use of Welby My-Karte (duration of use) and the reasons for discontinuation of use of Welby My-Karte (reasons for discontinuation) will be investigated in patients with lifestyle disease aged 40 years or more who are receiving treatment and who are using, have used, or will use Welby My-Karte to collect information on PRO.

Basic objectives2

Others

Basic objectives -Others

To identify factors related to preferable disease control and occurrences of new complications in those who are enrolled in the present study (subjects) and evaluate the effects of PRO-based treatment in those subjects, the following information will be collected:
- Subject characteristics
- Results of a questionnaire survey conducted at enrollment
- Retrospective data
- Prospective data
- Condition of subjects at the end of study
Furthermore, to plan a clinical study for examining the factors related to control and progression of primary diseases and examining the effects of clinical inertia on these factors, on the basis of the transition of the obtained research data.

Trial characteristics_1

Others

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

1) The continuation rate
2) The duration of use: the mean duration of use and the distribution of the duration of use
3) The reasons for discontinuation

Key secondary outcomes

- Subject characteristics
- Results of a questionnaire survey conducted at enrollment
- Retrospective data
- Prospective data
- Condition of subjects at the end of screening

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

40

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Those who fulfill the following criteria:
- Those with a lifestyle disease (diabetes, hypertension, or hyperlipidemia) diagnosed six months or more before participation in the present study, or those who have smoking habits (including electronic cigarettes and heated tobacco products) for six months or more before participation in the present study
- Those who have been receiving drug therapy for diabetes, hypertension, or hyperlipidemia for six months or more at the medical institution participating in the present study
- Those who had used Welby My-Karte before participation in the present study (regardless of whether they use it or not when they participate in the present study) and those who started using it before December 31, 2019 (the start date refers to the date when they are registered as users.)
- Those aged 40 years or more
- Those who provide written consent to participation in the present study

Key exclusion criteria

Those who meet any of the following criteria:
- Those who the principal investigator or sub-investigator considers to have other serious diseases
- Those who the principal investigator or sub-investigator considers to be ineligible for the present study
- Those with type 1 diabetes

Target sample size

1000

Name of lead principal investigator

1st name	Osamu
Middle name
Last name	Tomonaga

Organization

Diabetes And Lifestyle Center,Tomonaga Clinic

Division name

Diabetes And Lifestyle Center,Tomonaga Clinic

Zip code

160-0022

Address

9F,Shinyon-curumu Bld.4-2-23,Shinjuku-ku,Tokyo,160-0022,JAPAN

TEL

03-3351-0032

Email

boss@tomonaga-clinic.com

Name of contact person

1st name	Yuko
Middle name
Last name	Ishikawa

Organization

Satt Co., Ltd

Division name

Clinical research group

Zip code

160-0022

Address

ACN Shinjuku Bld. 5F, 2-12-8 Shinjuku, Shinjuku-ku, Tokyo, Japan

TEL

03-5312-5026

Homepage URL

Email

e-promis@sa-tt.co.jp

Institute

Diabetes And Lifestyle Center,Tomonaga Clinic

Institute

Department

Personal name

Organization

Welby Co., Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Welby Co., Ltd

Name of secondary funder(s)

Organization

Hattori clinic ethics review board

Address

1-15-18 Hachioji, Bessho, Tokyo

Tel

03-3470-3360

Email

reception-office@hattori-crb.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人社団ライフスタイルともながクリニック糖尿病・生活習慣病センター（東京都）、ふくだ内科クリニック（大阪府）、高橋医院（大阪府）、天神田中内科クリニック（大阪府）、泉岡医院（大阪府）、しぶや医院（埼玉県）、細田診療所（東京都）、医療法人社団三碧会はるクリニック（東京都）、医療法人社団晴英会西東京ペインクリニック（東京都）、医療法人敬寿会やすい内科（愛知県）、高橋内科医院（秋田県）、医療法人社団柊風会阿部内科医院（兵庫県）、医療法人社団菅沼会腎内科クリニック世田谷（東京都）、医療法人内科・消化器科みつはし医院（福島県）、医療法人爽陽会鳴瀬病院（福島県）、医療法人社団安寿厚生会らいふライフサイエンス内科クリニック（東京都）、医療法人社団椰子の実会たかざわ医院（千葉県）、メディカルクリニック渋谷（東京都）、医療法人社団福寿会武田医院（福島県）、すみた内科・循環器内科（神奈川県）、はとりクリニック（神奈川県）、佐久間クリニック（神奈川県）

Date of disclosure of the study information

2020

Year

03

Month

02

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

675

Results

Results date posted

Results Delayed

Delay expected

Results Delay Reason

Analyzing

Date of the first journal publication of results

Baseline Characteristics

Patients with lifestyle disease aged 40 years or more who are receiving treatment and who are using,　or have used Welby My-Karte.

Participant flow

FPI: March 18, 2020
LPO: November 4, 2020

Adverse events

None

Outcome measures

1) The continuation rate
2) The duration of use: the mean duration of use and the distribution of the duration of　use
3) The reasons for discontinuation

Plan to share IPD

None

IPD sharing Plan description

None

Recruitment status

Completed

Date of protocol fixation

2019

Year

12

Month

16

Day

Date of IRB

2019

Year

12

Month

20

Day

Anticipated trial start date

2020

Year

03

Month

01

Day

Last follow-up date

2020

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

1) Changes in patients awareness of treatments for lifestyle diseases are important in the treatment, and help the patients improve their dietary and exercise habits.
2) The collection of information on PRO might contribute to changes in patients awareness of lifestyle diseases.
3) Information on PRO has not been used to investigate the factors affecting the continuous use of Welby My-Karte, but it is considered that analyses of information on PRO may contribute to reduction of the number of patients who discontinue use of Welby My-Karte.
4) Appropriate early treatment of lifestyle diseases might be useful to prevent the diseases from becoming more severe and other diseases from occurring in elderly patients.
5) One of the problems related to the existing treatments for lifestyle diseases is that no treatment is provided in consideration of patients condition. This problem is referred to as clinical inertia. To resolve the problem, it is important to collect information on PRO and share it among patients and physicians.

Registered date

2020

Year

03

Month

02

Day

Last modified on

2021

Year

03

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045149