UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011404 |
|---|---|
| Receipt number | R000013349 |
| Scientific Title | Development of the self-management education program for COPD patients using iPad |
| Date of disclosure of the study information | 2013/08/08 |
| Last modified on | 2013/08/07 15:30:46 |
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Basic information
Public title
Development of the self-management education program for COPD patients
using iPad
Acronym
Development of the self-management education program for COPD patients
using iPad
Scientific Title
Development of the self-management education program for COPD patients
using iPad
Scientific Title:Acronym
Development of the self-management education program for COPD patients
using iPad
Region
| Japan |
Condition
Condition
COPD
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the adherence to the educational program provided by the application software of iPad and to assess the effect of the program on dyspnea, HRQL, physical activities, and actions when patients had exacerbations
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adherence to the educational program, dyspnea, HRQL, physical activities, and actions when patients had exacerbations
Key secondary outcomes
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
| Device,equipment |
Interventions/Control_1
After the two-week observational period, the self-management education is conducted at home for six week. The educational program is provided by the application software of iPad which was newly-developed for the study. The program consists of self-monitoring of symptoms and amount of exercise, motion pictures of stretching exercise, and educational contents for self-management of COPD. Assessments such as HRQL, lung information needs(LINQ), 6MWT will be conducted before and after the intervention. Program-adherence and entered six-week information such as changes of symptoms, amount of exercise, actions when patients had exacerbations will also be evaluated.
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
moderate to severe COPD (stage II - IV:JRS COPD guideline)
Key exclusion criteria
Attendee on pulmonary rehabilitation session within a year. Patients who had exacerbation within 30 days. Patients with bronchial asthma, ischemic heart disease, uncontrolled hypertension, gait disturbance due to orthopedic or cerebrovascular disease, cognitive impairment. The individual who is assessed as a non-candidate for the study by a physician due to other disease conditions.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Ueki |
Organization
Juntendo University Graduate School of Health Care and Nursing
Division name
Clinical Research Unit of Respiratory Pathophysiology
Zip code
Address
2-5-1, Takasu, Urayasu City, Chiba 279-0023
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Juntendo University Graduate School of Health Care and Nursing
Division name
Clinical Research Unit of Respiratory Pathophysiology
Zip code
Address
TEL
Homepage URL
junueki@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Graduate School of Health Care and Nursing
Institute
Department
Personal name
Funding Source
Organization
Environmental Restoration and Conservation Agency
Organization
Division
Category of Funding Organization
Other
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
| 2013 | Year | 08 | Month | 08 | 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
| 2013 | Year | 03 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 12 | 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
| 2013 | Year | 08 | Month | 07 | Day |
Last modified on
| 2013 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013349
