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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027515
Receipt No. R000031541
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
Date of disclosure of the study information 2017/06/07
Last modified on 2019/03/29

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

Public contact
1st name of contact person
1st name
Middle name
Last name TANAKA TAKAMI
Organization Japanese Red Cross College of Nurisng
Division name Nursing
Zip code
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
Address
Tel
Email

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 Enrolling by invitation
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
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 05 Month 28 Day
Last modified on
2019 Year 03 Month 29 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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