UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049301 |
|---|---|
| Receipt number | R000054175 |
| Scientific Title | Development and valuation of a Nurse Training Program on Dignity-Centered Care of People with Idiopathic Pulmonary Fibrosis: A Mixed Method Research |
| Date of disclosure of the study information | 2022/10/24 |
| Last modified on | 2023/04/24 09:58:57 |
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Basic information
Public title
Development and valuation of a Nurse Training Program on Dignity-Centered Care of People with Idiopathic Pulmonary Fibrosis: A Mixed Method Research
Acronym
Evaluation study of a Nurse Training Program on Dignity-Centered Care of People with
Idiopathic Pulmonary Fibrosis: A Mixed Method Research
Scientific Title
Development and valuation of a Nurse Training Program on Dignity-Centered Care of People with Idiopathic Pulmonary Fibrosis: A Mixed Method Research
Scientific Title:Acronym
Evaluation study of a Nurse Training Program on Dignity-Centered Care of People with
Idiopathic Pulmonary Fibrosis: A Mixed Method Research
Region
| Japan |
Condition
Condition
idiopathic pulmonary fibrosis
Classification by specialty
| Nursing | Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether providing one month of e-learning in nursing practice of idiopathic pulmonary fibrosis can increase nursing practice opportunities for nurses using a mixed methods research based on an explanatory sequential design.
Basic objectives2
Others
Basic objectives -Others
To evaluate whether providing one month of e-learning in nursing practice of idiopathic pulmonary fibrosis can increase the self-efficacy of nurses using a mixed methods research based on an explanatory sequential design.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Nursing practice items
Key secondary outcomes
Self-efficacy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Receiving one month of e-learning in nursing practice for idiopathic pulmonary fibrosis patients
Interventions/Control_2
Not receiving e-learning in nursing practice for idiopathic pulmonary fibrosis patients
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 following comprises the inclusion criteria:
1) Those who are either a certified nurse in chronic respiratory disease or a certified nurse specialist in chronic care (subspecialty: respiratory disease nursing).
2) Those who can answer the questionnaire after their nursing practice with idiopathic pulmonary fibrosis (IPF) patients in the outpatient capacity or at home
3) Those who have obtained consent electronically
4) Those who can create an environment to connect to the Internet other than free Wi-Fi.
Key exclusion criteria
The exclusion criteria are as follows:
1) Those who have not had the opportunity to practice nursing for IPF patients.
2) Those who belong to a pediatric hospital, a children rehabilitation ryoiku center, a treatment facility specializing in other diseases, or an educational institution
3) Those who cannot procure, use, or operate the necessary equipment, such as computers, to undertake e-learning by themselves, as well as a proper communication environment.
4) Those who are deemed inappropriate for study participation by the principal investigator.
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | Yasuko |
| Middle name | |
| Last name | Igai |
Organization
St. Luke's International University
Division name
Graduate School of Nursing Science
Zip code
104-0044
Address
10-1 Akashi-cho, Chuo-ku, Tokyo
TEL
03-6226-6381
igai@slcn.ac.jp
Public contact
Name of contact person
| 1st name | Yasuko |
| Middle name | |
| Last name | Igai |
Organization
St. Luke's International University
Division name
Graduate School of Nursing Science
Zip code
104-0044
Address
10-1 Akashi-cho, Chuo-ku, Tokyo
TEL
03-6226-6381
Homepage URL
igai@slcn.ac.jp
Sponsor or person
Institute
St. Luke's International University, Graduate School of Nursing Science
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology Japan
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
St. Luke's International University Research Administration Office
Address
10-1 Akashi-cho, Chuo-ku, Tokyo
Tel
03-5550-2423
kenkyukikaku@luke.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 24 | 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
52
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
| 2022 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 20 | Day |
Date of closure to data entry
| 2023 | Year | 02 | Month | 19 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 24 | Day |
Last modified on
| 2023 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054175
