UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031861
Receipt No. 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 2018/03/23

* 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 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
Email 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
Email 16dn002@slcn.ac.jp

Sponsor
Institute St. Luke's International University
Institute
Department

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
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

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 Preinitiation
Date of protocol fixation
2018 Year 03 Month 22 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 23 Day
Last modified on
2018 Year 03 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036345

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.