UMIN-CTR Clinical Trial

Basic information
Public title	A Survey of Satisfaction of long-term rehabilitation for outpatients with Chronic respiratory disease
Acronym	A Survey of Satisfaction of long-term rehabilitation for outpatients with Chronic respiratory disease
Scientific Title	A Survey of Satisfaction of long-term rehabilitation for outpatients with Chronic respiratory disease
Scientific Title:Acronym	A Survey of Satisfaction of long-term rehabilitation for outpatients with Chronic respiratory disease
Region	Japan

Condition
Condition	Chronic respiratory disease
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify improvement points and problems of rehabilitation to help provide better rehabilitation service.
Basic objectives2	Others
Basic objectives -Others	N/A
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Customer Satisfaction Scale based on Need Satisfaction(CSSNS)
Key secondary outcomes	Lung function, Rehabilitation history and frequency, Motivation of starting and continuing rehabilitation, COPD Assessment test(CAT), Modified MRC dyspnea scale, Satisfaction of needs, Improvement of self-awareness

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	The chronic respiratory disease patients visiting Jobu hospital for respiratory diseases more than 1-year. The patients who agreed in written to join this clinical trial.
Key exclusion criteria	The patients with dementia cannot answer questionnaire. Patients who are unable to write.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Mai Middle name Last name Yumoto
Organization	Jobu hospital for respiratory diseases
Division name	Department of rehabilitation
Zip code	371-0048
Address	586-1, taguchi, Maebashi, Gunma, Japan
TEL	027-232-5000
Email	y.20200817@gmail.com

Public contact
Name of contact person	1st name Mai Middle name Last name Yumoto
Organization	Jobu hospital for respiratory diseases
Division name	Department of rehabilitation
Zip code	371-0048
Address	586-1, taguchi, Maebashi, Gunma, Japan
TEL	027-232-5000
Homepage URL
Email	y.20200817@gmail.com

Sponsor
Institute	Jobu hospital for respiratory diseases
Institute
Department

Funding Source
Organization	Non
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	Jobu hospital for respiratory diseases
Address	586-1, taguchi, Maebashi, Gunma, Japan
Tel	027-232-5000
Email	ichiyokai-jkn@mvd.biglobe.ne.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	2020 Year 08 Month 25 Day

Related information
URL releasing protocol	Non
Publication of results	Unpublished

Result
URL related to results and publications	Non
Number of participants that the trial has enrolled	13
Results	Significant correlations were found between CSSNS and satisfaction with instruction on breathlessness and satisfaction with instruction on how to cope with breathlessness.
Results date posted	2022 Year 03 Month 23 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Patients with chronic respiratory disease who have been regularly attending outpatient rehabilitation for more than 1 year.
Participant flow	At the end of the outpatient rehabilitation, a different therapist from the one in charge explained the study and distributed questionnaires to the patients who gave their consent to answer the questions. After the responses were received, they were collected in a collection box.
Adverse events	Non
Outcome measures	Age, gender, name and severity of disease, rehabilitation history, frequency and contents, COPD assessment test, mMRC, CSSNS, self-made questionnaire.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2020 Year 08 Month 19 Day
Date of IRB	2020 Year 08 Month 26 Day
Anticipated trial start date	2020 Year 09 Month 01 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry	2022 Year 03 Month 23 Day
Date trial data considered complete
Date analysis concluded	2021 Year 04 Month 30 Day

Other
Other related information	Non

Management information
Registered date	2020 Year 08 Month 25 Day
Last modified on	2022 Year 03 Month 23 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047439