UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052798 |
|---|---|
| Receipt number | R000057316 |
| Scientific Title | Development of online support program for Chronic obstructive pulmonary disease patients- Feasibility study- |
| Date of disclosure of the study information | 2023/11/15 |
| Last modified on | 2024/01/25 19:33:47 |
* 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
Development of online support program for Chronic obstructive pulmonary disease patients - Feasibility study-
Acronym
Development of online support program for Chronic obstructive pulmonary disease patients- Feasibility study-
Scientific Title
Development of online support program for Chronic obstructive pulmonary disease patients- Feasibility study-
Scientific Title:Acronym
Development of online support program for Chronic obstructive pulmonary disease patients- Feasibility study-
Region
| Japan |
Condition
Condition
Chronic obstractive pulmonary disease
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess participants' acceptability (usefulness, ease of engagement and satisfaction) with the programme and delivery methods.
Basic objectives2
Others
Basic objectives -Others
(i) To identify the participants' needs for self-management education in order to improve the programme.
(ii) To identify practical strategies to increase participants' self-efficacy with a view to improving the programme.
(iii) To assess the acceptability (usefulness, ease of engagement and satisfaction) of the remote self-monitoring system.
(iv) To conduct a preliminary test of the questionnaire.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Qualitative description focusing on acceptance to videoconferencing software (Teams) and changes in awareness and behaviour as a result of self-monitoring system.
Key secondary outcomes
(i) Qualitative description about the content of self-management education needed by COPD patients.
(ii) Qualitative description about self-efficacy and the process of obtaining self-management behavior for COPD patients.
(iii) Scores on the questionnaire on the acceptability of the self-monitoring system, response rate (percentage of valid responses registered), transmission rate (percentage of days data were transmitted during the period), presence and nature of problems that occurred during the period.
(iv) the Hospital and depression scale (HADS), the Generalised Self-Efficacy Scale (GSES) and the St' George's Respiratory Questionnaire (SGRQ)
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants measure their temperature, pulse rate and transcutaneous oxygen saturation at home by using an electronic thermometer and pulse oximeter.
In addition, the COPD assessment score, the presence and nature of sputum and a free description of their physical condition are entered into a self-monitoring system through a tablet device and transmitted to the researcher.
Program will be conducted twice preliminary with providing information and participant interaction. Participants attend online at home.
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
(1) Those who have been diagnosed with chronic obstructive pulmonary disease (COPD) by a physician.
(2) COPD is the main cause of the disease and physical co-morbidities do not affect ADLs.
3) Shortness of breath that interferes with daily activities (mMRC 1 or higher)
4) Those with a respiratory condition that allows for a 60-minute discussion, either in person or online
5) Those whose cognitive and physical functioning is maintained and does not interfere with participation in the needs assessment survey. Those who have family members or other support persons around them even if they have declined.
6) Those who wish to have the opportunity to speak with other patients and whose attending physician has determined that the person is receptive to the current situation to the extent that he/she is able to listen to other patients.
Key exclusion criteria
(1) Persons who have been judged by their physician to be inappropriate to participate in the research
(2) Patients who are terminally ill.
(3) Patients whose cognitive function has declined to the extent that it is difficult to communicate with other patients, as judged by the attending physician or the resercher during normal consultation hours and during conversations.
(4) Patients who have a concomitant psychiatric disorder or are being examined by a palliative care team.
(5) Those who cannot read and write Japanese.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Mihoko |
| Middle name | |
| Last name | FUJII |
Organization
National College of Nursing, Japan
Division name
Doctral program student
Zip code
204-8575
Address
Umezono 1-2-1, Kiyose, Tokyo, Japan
TEL
042-495-2211
fujiim@d20.ncn.ac.jp
Public contact
Name of contact person
| 1st name | Mihoko |
| Middle name | |
| Last name | Fujii |
Organization
National College of Nursing, Japan
Division name
Doctral program student
Zip code
204-8575
Address
Umezono 1-2-1, Kiyose, Tokyo, Japan
TEL
042-495-2211
Homepage URL
fujiim@d20.ncn.ac.jp
Sponsor or person
Institute
National College of Nursing, Japan
Institute
Department
Personal name
Mihoko FUJII
Funding Source
Organization
This study was funded by the funding of Sasakawa hoken fundation.
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
National health center for global health and medicine, National College of Nursing, Japan
Address
Umezono 1-2-1, Kiyose, Tokyo, Japan
Tel
042-495-2211
fujiim@d20.ncn.ac.jp
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
| 2023 | Year | 11 | Month | 15 | 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
7
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
| 2023 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 14 | Day |
Last modified on
| 2024 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057316
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
