UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000039658 |
| Receipt No. | R000045149 |
| Scientific Title | A cohort study on patient-reported outcomes (PRO) in patients with lifestyle disease who have used Welby My-Karte |
| Date of disclosure of the study information | 2020/03/02 |
| Last modified on | 2021/03/03 (Ver. 5) |
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| Basic information | ||
| 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 |
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| Condition | |||||
| Condition | Those with a lifestyle disease (diabetes, hypertension, or hyperlipidemia) | ||||
| Classification by specialty |
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| Classification by malignancy | Others | ||||
| Genomic information | NO | ||||
| Objectives | |
| 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 |
| Assessment | |
| 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 |
| 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 |
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| Age-upper limit |
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| 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 |
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| 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 |
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| Target sample size | 1000 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
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| 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 | ||||||
| boss@tomonaga-clinic.com | |||||||
| Public contact | |||||||
| Name of contact person |
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| 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 | |||||||
| e-promis@sa-tt.co.jp | |||||||
| Sponsor | |
| Institute | Diabetes And Lifestyle Center,Tomonaga Clinic |
| Institute | |
| Department | |
| Funding Source | |
| Organization | Welby Co., Ltd |
| Organization | |
| Division | |
| Category of Funding Organization | Profit organization |
| Nationality of Funding Organization | Japan |
| Other related organizations | |
| Co-sponsor | Welby Co., Ltd |
| Name of secondary funder(s) | |
| IRB Contact (For public release) | |
| Organization | Hattori clinic ethics review board |
| Address | 1-15-18 Hachioji, Bessho, Tokyo |
| Tel | 03-3470-3360 |
| reception-office@hattori-crb.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 | 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） |
| Other administrative information | |||||||
| Date of disclosure of the study information |
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| Related information | |
| URL releasing protocol | |
| Publication of results | Unpublished |
| Result | ||
| URL related to results and publications | ||
| Number of participants that the trial has enrolled | 675 | |
| Results | ||
| Results date posted | ||
| Results Delayed |
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| 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 |
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| 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 |
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| Plan to share IPD | None | |
| IPD sharing Plan description | None | |
| Progress | |||||||
| Recruitment status | Completed | ||||||
| Date of protocol fixation |
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| Date of IRB |
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| Anticipated trial start date |
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| Last follow-up date |
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| Date of closure to data entry | |||||||
| Date trial data considered complete | |||||||
| Date analysis concluded | |||||||
| Other | |
| 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. |
| Management information | |||||||
| Registered date |
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045149 |
