UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029887 |
|---|---|
| Receipt number | R000034061 |
| Scientific Title | Efficacy of support program by multiple professionals for patients with interstitial pneumonia on patients' disease understanding, self-effectiveness, quality of life, and adherence. |
| Date of disclosure of the study information | 2017/11/15 |
| Last modified on | 2017/11/08 15:43:54 |
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Basic information
Public title
Efficacy of support program by multiple professionals for patients with interstitial pneumonia on patients' disease understanding, self-effectiveness, quality of life, and adherence.
Acronym
Efficacy of support program by multiple professionals for patients with interstitial pneumonia.
Scientific Title
Efficacy of support program by multiple professionals for patients with interstitial pneumonia on patients' disease understanding, self-effectiveness, quality of life, and adherence.
Scientific Title:Acronym
Efficacy of support program by multiple professionals for patients with interstitial pneumonia.
Region
| Japan |
Condition
Condition
interstitial pneumonia
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the efficacy of our team, which consists of physicians, nurses, pharmacists, physical therapists, nutritionists and medical social workers, on patients' understanding of disease, self-effectiveness, quality of life, medication adherence.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
quality of life evaluated with EQ-5D
Key secondary outcomes
Self-effectiveness and anxiety evaluated with self-completion questionnaire. Physical activeity and body composition. Nutritional status. Adherence to therapy.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Interstitial pneumonia patients who are receiving long-term oxygen therapy take education from nurses in outpatient setting. Physical therapists conduct rehabilitation and nutritionists provide adveices on dietary habits both in outpatient setting.
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.Interstitial pneumonia patients who are receiving long-term oxygen therapy.
2.Interstitial pneumonia patients who are newly prescribed with antifibrotic agents (prifenidone or nintedanib).
Key exclusion criteria
1.Patients who are incapable of visiting hospital due to severe respiratory failure or other reasons.
2.Patients who are incapable of describing their conditions due to dimentia or mental disorders.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keisuke Tomii |
Organization
Kobe City Medical Center, General Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
2-1-1 Minatojima-Minami-cho CHuo-ward Kobe
TEL
078-302-4321
ktomii@kcho.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryobu Mori |
Organization
Kobe City Medical Center, General Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
2-1-1 Minatojima-Minami-cho CHuo-ward Kobe
TEL
078-302-4321
Homepage URL
ryobu126@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine
Kobe City Medical Center, General Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Respiratory Medicine
Kobe City Medical Center, General Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 11 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 14 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
before initiation
Management information
Registered date
| 2017 | Year | 11 | Month | 08 | Day |
Last modified on
| 2017 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034061
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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