UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046403 |
|---|---|
| Receipt number | R000052946 |
| Scientific Title | Web-based survey of pediatricians' perception on the burden of respiratory syncytial virus in Japan |
| Date of disclosure of the study information | 2022/02/01 |
| Last modified on | 2024/06/21 13:52:20 |
* 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
Web-based survey of pediatricians' perception on the burden of respiratory syncytial virus in Japan
Acronym
Web-based survey of pediatricians' perception on the burden of respiratory syncytial virus in Japan
Scientific Title
Web-based survey of pediatricians' perception on the burden of respiratory syncytial virus in Japan
Scientific Title:Acronym
Web-based survey of pediatricians' perception on the burden of respiratory syncytial virus in Japan
Region
| Japan |
Condition
Condition
respiratory syncytial virus
Classification by specialty
| Infectious disease | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate pediatricians ' perception on the burden of RSV in young children, needs in clinical management of the case, and its impact on caregivers and health care professionals in Japan
Basic objectives2
Others
Basic objectives -Others
Pediatricians' perception on the burden of disease
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pediatricians' perception on
-Burden of RSV infection among children
-Impact of RSV infection on caregivers and health care professionals
-Medical needs in the management of RSV infection among children
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.pediatricians who have treated at least 3 RSV patients in the last 12 months.
2.Pediatricians who are currently practicing in outpatient, inpatient or emergency department setting.
Key exclusion criteria
1.pediatricians who are currently employed by the pharmaceutical industry
2.pediatricians who were previously employed by the pharmaceutical industry
3.pediatricians who have less than two years of experience in clinical practice
Target sample size
340
Research contact person
Name of lead principal investigator
| 1st name | Youngju |
| Middle name | |
| Last name | Kim |
Organization
MSD K.K.
Division name
Medical Affairs
Zip code
102-8667
Address
KITANOMARU SQUARE,1-13-12 Kudan-kita, Chiyoda-ku, Tokyo 102-8667, JAPAN
TEL
+81-3-6272-1276
ldgproject@merck.com
Public contact
Name of contact person
| 1st name | Yukari |
| Middle name | |
| Last name | Ohta |
Organization
MSD K.K.
Division name
Medical Affairs
Zip code
102-8667
Address
KITANOMARU SQUARE,1-13-12 Kudan-kita, Chiyoda-ku, Tokyo 102-8667, JAPAN
TEL
+81-3-6272-1185
Homepage URL
ldgproject@merck.com
Sponsor or person
Institute
MSD K.K.
Institute
Department
Personal name
Funding Source
Organization
MSD K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
IQVIA Solution Japan K.K.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation TOUKEIKAI Kitamachi Clinic ERB
Address
1-1-3,Kichijoji-kitamachi,Musashino-shi,Tokyo,180-0001,Japan
Tel
03-6779-8116
chi-pr-ec-kitamachi@cmicgroup.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
NA
Publication of results
Published
Result
URL related to results and publications
https://www.iyaku.info/column/?id=1715320863-782085&ca=3
Number of participants that the trial has enrolled
300
Results
RSV infection is a common and severe pediatric illness. While rapid diagnostic kits are satisfactory, there is room for improvement in treating severe cases and preventing the infection in high-risk children. Caregivers and families face substantial anxiety and stress, resulting in significant economic and physical burdens. Healthcare providers are concerned about patient deterioration and the associated economic and occupational burdens. The RSV season poses a significant challenge for healthcare staff.
Results date posted
| 2024 | Year | 06 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The main survey was conducted from November 27, 2022, to December 5, 2022. Table 1 presents the background of the 300 participating physicians. Among them, 81.0% were male, with a mean age (standard deviation, SD) of 49.3 (12.3) years and a mean experience of 22.9 (10.9) years. A total of 243 (81.0%) were board-certified pediatricians by the Japan Pediatric Society, while 21 (7.0%) were certified by the Japanese Society of Pediatric Infectious Diseases. Over half, 154 (51.3%), worked primarily in general hospitals. Among the physicians, 83 (27.7%) either had no children or preferred not to answer. Of the physicians with children, 64 (21.3%), 34 (11.3%), and 106 (35.3%) reported having children aged 7-12 years, 13-15 years, and 16 years or older, respectively. Furthermore, out of the physicians with children, 108 (49.8%) reported no previous experience of their children being infected with RS virus.
Participant flow
Participants were Japanese pediatricians who had treated three or more patients with RS virus infection in the past year and currently provided medical care in outpatient clinics, inpatient settings, or emergency departments. The qualitative interviews were conducted with participants recruited from PD Research Inc.'s panel, while participants for the pilot and main surveys were recruited from Nikkei Business Publications Inc.'s panel through Rakuten Insight Inc. Physicians who participated in the pilot survey were excluded from the main survey. Nikkei Business Publications Inc.'s panel is widely used for market research and surveys related to clinical activities, with approximately 130,000 registered physicians as of July 2021, including approximately 9,500 pediatricians.
Adverse events
There were no Adverse events in this study.
Outcome measures
1.Frequency, severity, and prevention needs of RSV infection as perceived by pediatricians.
2.Needs, satisfaction, and burden of caregivers/families and healthcare providers in the management of RSV infection as perceived by pediatricians.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Pediatricians' perception on the burden of respiratory syncytial virus, random sampling prospective study
Management information
Registered date
| 2021 | Year | 12 | Month | 17 | Day |
Last modified on
| 2024 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052946
