UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054912 |
|---|---|
| Receipt number | R000062700 |
| Scientific Title | Prognostic awareness in patients with interstitial lung diseases: A multi-center cross-sectional survey |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2025/07/09 09:05:30 |
* 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
Prognostic awareness in patients with interstitial lung diseases: A multi-center cross-sectional survey
Acronym
Prognostic awareness in patients with interstitial lung diseases: A multi-center cross-sectional survey
Scientific Title
Prognostic awareness in patients with interstitial lung diseases: A multi-center cross-sectional survey
Scientific Title:Acronym
Prognostic awareness in patients with interstitial lung diseases: A multi-center cross-sectional survey
Region
| Japan |
Condition
Condition
Interstitial lung diseases
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the reality of prognostic awareness in ILD patients and the association between prognostic awareness and disease severity and quality of life through a questionnaire survey.
Basic objectives2
Others
Basic objectives -Others
to clarify the association between prognostic awareness and depression.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of the overall population with or without prognostic awareness
Key secondary outcomes
Different prognostic perceptions when grouped by disease progression (GAP stage)
Association of prognostic awareness with quality of life (total CAT score, EQ5D5L) and degree of dyspnea (mMRS, NRS)
Association between prognosis awareness and PHQ9 scores
Association between prognostic awareness and the status of conversations with the patient's doctor
Understanding Patient Needs
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria are eligible
(1) Patients who meet the diagnosis of idiopathic pulmonary fibrosis or progressive fibrosing interstitial lung diseases (PF-ILD) by the respiratory medicine department at the facility.
(2) Patients who have been informed of the difficulty of cure and acute exacerbation of interstitial lung disease.
(3) Patients must be at least 20 years of age.
(4) Patients whose consent to participate in this study has been obtained by signing a consent form in person.
Key exclusion criteria
Patients who meet any of the following criteria will not be included in this study.
(1) Patients with complications of active malignancy requiring chemotherapy.
(2) Patients who are unable to complete the self-administered questionnaire due to dementia, mental retardation, or visual impairment.
(3) Patients who have had an acute exacerbation of interstitial lung disease within 3 months of onset.
(4) Patients who need acute treatment for pneumonia or other diseases.
(5) Implementation of the research is undesirable as a comprehensive judgment by doctors, nurses, and other multidisciplinary professionals due to strong distrust or misunderstanding of the medical care received or extremely poor relationships with medical personnel.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Suda |
Organization
Hamamatsu university school of medicine
Division name
Respiratory Medicine
Zip code
431-3192
Address
1-20-1 Handayama, Chuo Ward, Hamamatsu, Shizuoka, 431-3192, Japan
TEL
053-435-2263
suda@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Shusuke |
| Middle name | |
| Last name | Yazawa |
Organization
Hamamatsu university school of medicine
Division name
Respiratory Medicine
Zip code
431-3192
Address
1-20-1 Handayama, Chuo Ward, Hamamatsu, Shizuoka, 431-3192, Japan
TEL
053-435-2263
Homepage URL
sh.yazawa@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu university school of medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
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
the ethics board of Hamamatsu university school of medicine
Address
1-20-1 Handayama, Chuo Ward, Hamamatsu, Shizuoka, 431-3192, Japan
Tel
053-435-2263
rinri@hama-med.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
| 2024 | Year | 08 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a survey study of ILD patients: a multicenter cross-sectional study designed to evaluate the prognostic awareness of ILD patients.
Patients with ILD who meet the selection criteria are asked to complete a self-administered questionnaire after receiving a written explanation of the study and consent from the physician in charge at each site. After the questionnaires are answered by each facility, each participating facility will mail the questionnaires to the questionnaire secretariat (located at Tohoku University), and the responses will be tabulated. The questionnaires will be numbered so that they can be linked to the patient's background information obtained from the medical records at the time of analysis. The consent rate is expected to be approximately 85%. For the enrolled cases, each facility will be asked to conduct a medical record survey on patient background. A researcher at each participating facility will review the medical records and enter the information into a special survey form. No names or other personally identifiable information will be transcribed on the survey form, which will be controlled by a survey ID.
Management information
Registered date
| 2024 | Year | 07 | Month | 09 | Day |
Last modified on
| 2025 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062700
