UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027515 |
|---|---|
| Receipt number | 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 | 2020/05/28 20:49:59 |
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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
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
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
t-tanaka@redcross.ac.jp
Sponsor or person
Institute
Japanese Red Cross College of Nurisng
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031541
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
