UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052698 |
|---|---|
| Receipt number | R000060071 |
| Scientific Title | Effectiveness of the educational program about the breathlessness management support for patients with chronic respiratory disease: a randomized controlled trial |
| Date of disclosure of the study information | 2023/11/07 |
| Last modified on | 2024/10/14 11:01:17 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effectiveness of the educational program about the breathlessness management support for patients with chronic respiratory disease: a randomized controlled trial
Acronym
Effectiveness of the educational program about the breathlessness management support for patients with chronic respiratory disease: a randomized controlled trial
Scientific Title
Effectiveness of the educational program about the breathlessness management support for patients with chronic respiratory disease: a randomized controlled trial
Scientific Title:Acronym
Effectiveness of the educational program about the breathlessness management support for patients with chronic respiratory disease: a randomized controlled trial
Region
| Japan |
Condition
Condition
chronic respiratory disease
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine effectiveness of the modified educational program about the breathlessness management support of patients with chronic respiratory disease in general nurses.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency of the nursing support on breathlessness management
Key secondary outcomes
Confidence of nursing support on breathlessness management
Frequency of the nursing support on breathlessness management strategy
Confidence of nursing support on breathlessness management strategy
Difficulties with breathlessness management support
Attitudes for effective listening
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Participants receive an educational program.
Interventions/Control_2
Participants do not receive an educational program.
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
Nurses providing nursing care for at least two patients with chronic respiratory disease per week
No matter whether they work full-time or part-time
Any number of years of nursing experience
Can participate in the program online (preferably on a computer)
Key exclusion criteria
Certified nurse specialist in chronic care nursing and certified nurse in chronic respiratory nursing
Target sample size
176
Research contact person
Name of lead principal investigator
| 1st name | Kikuko |
| Middle name | |
| Last name | Mori |
Organization
University of Hyogo
Division name
College of Nursing Art & Science
Zip code
673-8588
Address
13-71 Kitaoji-cho, Akashi, Hyogo, Japan
TEL
078-925-9447
kikuko_mori@cnas.u-hyogo.ac.jp
Public contact
Name of contact person
| 1st name | Kikuko |
| Middle name | |
| Last name | Mori |
Organization
University of Hyogo
Division name
College of Nursing Art & Science
Zip code
673-8588
Address
13-71 Kitaoji-cho, Akashi, Hyogo, Japan
TEL
078-925-9447
Homepage URL
kikuko_mori@cnas.u-hyogo.ac.jp
Sponsor or person
Institute
University of Hyogo
Institute
Department
Personal name
Kikuko Mori
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Institutional Review Board College of Nursing Art and Science, University of Hyogo Research Institute of Nursing Care for People and Community
Address
13-71 Kitaoji-cho, Akashi, Hyogo,Japan
Tel
078-925-0860
N/A
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
| 2023 | Year | 11 | 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
| 2023 | Year | 08 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 23 | Day |
Last follow-up date
| 2024 | Year | 07 | 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
| 2023 | Year | 11 | Month | 05 | Day |
Last modified on
| 2024 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060071
