UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045932 |
|---|---|
| Receipt number | R000052432 |
| Scientific Title | Relationships of self-efficacy, physical function, and health-related quality of life among patients with interstitial lung disease |
| Date of disclosure of the study information | 2021/11/01 |
| Last modified on | 2023/05/09 18:51:44 |
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Basic information
Public title
Relationships of self-efficacy, physical function, and health-related quality of life among patients with interstitial lung disease
Acronym
Self-efficacy in ILD patients
Scientific Title
Relationships of self-efficacy, physical function, and health-related quality of life among patients with interstitial lung disease
Scientific Title:Acronym
Self-efficacy in ILD patients
Region
| Japan |
Condition
Condition
interstitial lung disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We assess self-efficacy in patients with interstitial lung disease (ILD), and to determine its relationship with disease-specific factors of ILD such as physical function and HRQOL.
Basic objectives2
Others
Basic objectives -Others
clinical characteristics
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Self-efficacy for health behaviors in chronically ill patients
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
stable patients with ILD
Key exclusion criteria
1) patients who are inability to complete questionnaires
2) patients who have had a recent exacerbation (within 4 weeks)
3) patients are not ambulant
4) severe comorbidities (active cancer, neurological or orthopedic disorders limiting exercise performance and self management)
5) those who cannot give their consent to participate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Kozu |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Physical Therapy Science
Zip code
852-8520
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7963
ryokozu@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Kozu |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Physical Therapy Science
Zip code
852-8520
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7963
Homepage URL
ryokozu@nagasaki-u.ac.jp
Sponsor or person
Institute
Department of Physical Therapy Science, Nagasaki University Graduate School of Biomedical Sciences
Institute
Department
Personal name
Funding Source
Organization
Department of Physical Therapy Science, Nagasaki University Graduate School of Biomedical Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital (Clinical Research Ethics Review Committee)
Address
1-7-1 Sakamoto, Nagasaki
Tel
095-819-7229
gaibushikin@ml.nagasaki-u.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
| 2021 | Year | 11 | 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
50
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
Completed
Date of protocol fixation
| 2021 | Year | 10 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We examine association of self-efficacy and physical function and HRQOL in patients with ILD.
Management information
Registered date
| 2021 | Year | 10 | Month | 30 | Day |
Last modified on
| 2023 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052432
