UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018943 |
|---|---|
| Receipt number | R000021910 |
| Scientific Title | Intervention and evaluation of education program for dietary change in COPD patients |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2016/07/01 16:35:27 |
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Basic information
Public title
Intervention and evaluation of education program for dietary change in COPD patients
Acronym
Intervention and evaluation of program for dietary change in COPD patients
Scientific Title
Intervention and evaluation of education program for dietary change in COPD patients
Scientific Title:Acronym
Intervention and evaluation of program for dietary change in COPD patients
Region
| Japan |
Condition
Condition
COPD
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to construct, practice, and evaluate the effect of the education program for dietary change in COPD patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Anthropometric outcome (height, weight, upper arm muscle circumference, triceps part subcutaneous fat thickness)
Assessing at baseline and 12-18 weeks later.
Key secondary outcomes
Knowledge and ingenuity of dietary intake method and nutritional intake
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The individual intervention is to educate the support program. At 4-6 weeks later we support patients against influence factors. At 8-12 weeks later we support patients to acquire skills related to behavior. At 10-15 weeks later we support patients to continue dietary change. First and second intervention consists of interview for about one hour and final intervention consists of interview by telephone for about ten minutes.
Interventions/Control_2
Control group
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
COPD patients
Key exclusion criteria
Exacerbation within one month
Obesity (BMI>25)
Cognitive impairment
Oral antipsychotic drugs
Malignant diseases
Endocrinological diseases
Gastrointestinal diseases
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taichiro Arimoto |
Organization
Kyoto Prefectural University of Medicine
Division name
Pulmonary Medicine
Zip code
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566
TEL
075-251-5513
arimt@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takako Mouri |
Organization
Osaka Prefecture University
Division name
Graduate School of Nursing
Zip code
Address
3-7-30, Habikino, Habikino-Shi, Osaka 583-8555
TEL
0729-50-2111
Homepage URL
dw601004@edu.osakafu-u.ac.jp
Sponsor or person
Institute
Department of Pulmonary Medicine,
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization
Local Government
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
| 2015 | Year | 10 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 08 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | 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
| 2015 | Year | 09 | Month | 08 | Day |
Last modified on
| 2016 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021910
| 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 |
