UMIN-CTR Clinical Trial

Basic information
Public title	Effects of nurse-led self-management support for persons with mild-severe chronic obstructive pulmonary disease at outpatient department: a randomized controlled trial
Acronym	Effects of nurse-led self-management support for persons with mild-severe chronic obstructive pulmonary disease at outpatient department: a randomized controlled trial
Scientific Title	Effects of nurse-led self-management support for persons with mild-severe chronic obstructive pulmonary disease at outpatient department: a randomized controlled trial
Scientific Title:Acronym	Effects of nurse-led self-management support for persons with mild-severe chronic obstructive pulmonary disease at outpatient department: a randomized controlled trial
Region	Japan

Condition
Condition	chronic obstructive pulmonary disease
Classification by specialty	Pneumology Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate of effectiveness of nurse-led self-management support for persons with mild-severe chronic obstructive pulmonary disease at outpatient department: a randomized controlled trial.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	St. George's Respiratory Questionnaire
Key secondary outcomes	Implementation of self-management and self-efficacy of self-management, BMI, grip strength, EQ-5D-5L, Medical bills, Number of hospitalizations, hospitalization days

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	self-management support through individual interview with a nurse(Intervention is an individual interview for 30 minutes, 3 interventions every two months, total intervention period is 4 months)
Interventions/Control_2	First phase: comparison period of 4 months. second phase: After the comparison period, self-management support through individual interview with a nurse(Intervention is an individual interview for 30 minutes, 3 interventions every two months, total intervention period is 4 months)
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 with COPD should satisfy the following conditions.(1)patients with stage I to stage III COPD without home oxygen therapy , (2)have consent and intention to participate in research, (3)Hospital visits intervals of 1 to 2 months and expectation of outpatient visit over 6 month, (4) can fill in questionnaires.
Key exclusion criteria	It does not satisfy the above criteria.
Target sample size	120

Research contact person
Name of lead principal investigator	1st name TAKAMI Middle name Last name TANAKA TAKAMI
Organization	Japanese Red Cross College of Nurisng
Division name	Nursing
Zip code	1500012
Address	4-1-3 Hiroo Shibuya-ku Tokyo
TEL	03-3409-0170
Email	t-tanaka@redcross.ac.jp

Public contact
Name of contact person	1st name TAKAMI Middle name Last name TANAKA TAKAMI
Organization	Japanese Red Cross College of Nurisng
Division name	Nursing
Zip code	1500012
Address	4-1-3 Hiroo Shibuya-ku Tokyo
TEL	03-3409-0170
Homepage URL
Email	t-tanaka@redcross.ac.jp

Sponsor
Institute	Japanese Red Cross College of Nurisng
Institute
Department

Funding Source
Organization	JSPS KAKENHI Grant Number JP16K12041
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	Japanese Red Cross College of Nursing
Address	4-1-3 Hiroo Shibuya-ku Tokyo
Tel	0334090170
Email	t-tanaka@redcross.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	地方独立行政法人大阪府立病院機構 大阪はびきの医療センター（大阪府） 沖縄県立中部病院（沖縄県） 新潟勤労者医療協会下越病院（新潟県） 日本赤十字社医療センター（東京都） 砂川市立病院（北海道） 芳賀赤十字病院（栃木県） 聖マリアンナ医科大学病院（神奈川県） 独立行政法人 国立病院機構 東京病院（東京都） 長岡赤十字病院（新潟県）

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 07 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	Completed
Date of protocol fixation	2017 Year 04 Month 09 Day
Date of IRB	2017 Year 01 Month 25 Day
Anticipated trial start date	2017 Year 06 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry	2020 Year 05 Month 28 Day
Date trial data considered complete	2020 Year 05 Month 28 Day
Date analysis concluded	2020 Year 05 Month 28 Day

Other
Other related information

Management information
Registered date	2017 Year 05 Month 28 Day
Last modified on	2020 Year 05 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031541