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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000011404
Receipt No. 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

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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
Email

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
Email junueki@juntendo.ac.jp

Sponsor
Institute Juntendo University Graduate School of Health Care and Nursing
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013349

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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