UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031861 |
|---|---|
| Receipt number | R000036345 |
| Scientific Title | Evaluation of a program on dignity-centered care for idiopathic pulmonary fibrosis (DIGNITY-IPF): A mixed methods study |
| Date of disclosure of the study information | 2018/04/19 |
| Last modified on | 2020/03/11 14:39:44 |
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Basic information
Public title
Evaluation of a program on dignity-centered care for idiopathic pulmonary fibrosis (DIGNITY-IPF): A mixed methods study
Acronym
Evaluation of program on DIGNITY-IPF using mix methods study
Scientific Title
Evaluation of a program on dignity-centered care for idiopathic pulmonary fibrosis (DIGNITY-IPF): A mixed methods study
Scientific Title:Acronym
Evaluation of program on DIGNITY-IPF using mix methods study
Region
| Japan |
Condition
Condition
Idiopathic pulmonary fibrosis
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the relationship between the change in self-esteem (quantitative data) and the recognition of living with IPF (qualitative data) using a mixed research method based on a convergent design.
Basic objectives2
Others
Basic objectives -Others
To evaluate the change in self-esteem, quality of life, anxiety, depression, symptoms.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Japanese version of Rosenberg's self-esteem scale
Key secondary outcomes
Japanese version of the hospital anxiety and depression scale
Japanese version of SGRQ-I
Scores of modified MRC scale
Scores of COPD assessment test cough domain
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Intervention frequency of program:
three times/month
Interventions/Control_2
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
Patients diagnosed as having idiopathic pulmonary fibrosis based on the guidelines of an official ATS/ERS/JRS/ALAT statement, and stages 2-4 in the classification of disease severity of idiopathic pulmonary fibrosis.
Key exclusion criteria
Patients with IPF and lung cancer, or patients with declining cognitive function
Target sample size
31
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoko Kamei |
Organization
St. Luke's International University
Division name
Graduate School of Nursing Science Division of Gerontological Nursing
Zip code
Address
10-1 Akashi-cho, Chuo-ku, Tokyo 104-0044, Japan
TEL
03-3543-6391
Kamei@slcn.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuko Igai |
Organization
St. Luke's International University
Division name
Graduate School of Nursing Science, Gerontological Nursing
Zip code
Address
10-1 Akashi-cho, Chuo-ku, Tokyo 104-0044, Japan
TEL
03-3543-6391
Homepage URL
16dn002@slcn.ac.jp
Sponsor or person
Institute
St. Luke's International University
Institute
Department
Personal name
Funding Source
Organization
The Yuumi Memorial Foundation for Home Health Care
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 04 | Month | 19 | 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
| 2018 | Year | 03 | Month | 22 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 24 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 14 | Day |
Date of closure to data entry
| 2019 | Year | 07 | Month | 08 | Day |
Date trial data considered complete
| 2019 | Year | 09 | Month | 17 | Day |
Date analysis concluded
| 2019 | Year | 09 | Month | 17 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 23 | Day |
Last modified on
| 2020 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036345
