UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of support program by multiple professionals for patients with interstitial pneumonia on patients' disease understanding, self-effectiveness, quality of life, and adherence.
Title of the study (Brief title)	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	Keisuke Tomii
Organization	Kobe City Medical Center, General Hospital
Division name	Department of Respiratory Medicine
Address	2-1-1 Minatojima-Minami-cho CHuo-ward Kobe
TEL	078-302-4321
Email	ktomii@kcho.jp

Public contact
Name of contact person	Ryobu Mori
Organization	Kobe City Medical Center, General Hospital
Division name	Department of Respiratory Medicine
Address	2-1-1 Minatojima-Minami-cho CHuo-ward Kobe
TEL	078-302-4321
Homepage URL
Email	ryobu126@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Department of Respiratory Medicine Kobe City Medical Center, General Hospital
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 10 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034061