UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048488 |
|---|---|
| Receipt number | R000055255 |
| Scientific Title | Verification of the Practicality of a Telehealth Support System to Realize Health Management and Lifestyle Guidance for COPD Patients at Home |
| Date of disclosure of the study information | 2022/07/27 |
| Last modified on | 2024/01/29 09:41:25 |
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Basic information
Public title
Verification of the Practicality of a Telehealth Support System to Realize Health Management and Lifestyle Guidance for COPD Patients at Home
Acronym
Verification of the Practicality of a Telehealth Support System to Realize Health Management and Lifestyle Guidance for COPD Patients at Home
Scientific Title
Verification of the Practicality of a Telehealth Support System to Realize Health Management and Lifestyle Guidance for COPD Patients at Home
Scientific Title:Acronym
Verification of the Practicality of a Telehealth Support System to Realize Health Management and Lifestyle Guidance for COPD Patients at Home
Region
| Japan |
Condition
Condition
chronic obstructive pulmonary disease(COPD)
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Elderly patients with chronic obstructive pulmonary disease (COPD) have a very high incidence of frailty, which falls somewhere between healthy and in need of care, and is a major factor in defining the prognosis of COPD patients. Approaches from the aspects of nutrition, exercise, and social participation are important for preventing frailty, and it has become clear that social participation is particularly effective in reducing the risk of frailty in the elderly.
The purpose of this study is to examine the effects of long-term use of a system that utilizes the functions of health observation using a tablet device and automatic acquisition of health-related data using a smartwatch on patients' physical activity and health-related quality of life.
Basic objectives2
Others
Basic objectives -Others
The goal of the project is to construct a support system that can guide COPD patients, most of whom are elderly in Japan, to change their behavior in order to continue exercise therapy at home, and to provide opportunities for social participation to elderly patients who have difficulty going out from the viewpoint of preventing frailty.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Physical activity (2 weeks before system use, 6 months during system use, 2 weeks after system use)
2.Health-related QOL (before and after system use)
3.Walking for 6 minutes
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
Institution is not considered as adjustment factor.
Blocking
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The data of the patient's health observation transmitted from the tablet device and acquired from the smartwatch will be evaluated by the principal investigator, and the results and advice will be sent to the patient via email.(6 months)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Male and female COPD patients over 20 years old.
2.Stable COPD patients (at home) who visit East-Nagano Hospital or Iizuna Hospital about once a month.
3.Patients with stable COPD (at home) who attend East-Nagano Hospital or Iizuna Hospital about once a month.
4.Patients who are interested in and willing to participate in health promotion and exercise, and who are capable of consenting to cooperate in the research.
Key exclusion criteria
1.Those whose COPD condition is not stable even if they are at home.
2.Those who have dyspnea on exertion in daily life with or without home oxygen therapy.
3.Who have significant limitations in their daily activities of daily livng.
4.Who have difficulty in walking or physical activity for more than 6 minutes continuously.
5.Who need to be monitored or chaperoned when exercising.
6.Who are restricted from exercise due to an injury or disease other than COPD.
7.Who are willing to exercise, but whose physician determines that participation in the study is not feasible.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Chisato |
| Middle name | |
| Last name | Ohashi |
Organization
National Institute of Technology, Toyama College
Division name
Department of General Education
Zip code
9330293
Address
Ebieneriya 1-2, Imizu, Toyama, Japan
TEL
+81766865201
c-ohashi@nc-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Chisato |
| Middle name | |
| Last name | Ohashi |
Organization
National Institute of Technology, Toyama College
Division name
Department of General Education
Zip code
9330293
Address
Ebieneriya 1-2, Imizu, Toyama, Japan
TEL
+81766865201
Homepage URL
c-ohashi@nc-toyama.ac.jp
Sponsor or person
Institute
National Institute of Technology, Toyama College
Institute
Department
Personal name
Funding Source
Organization
National Institute of Technology, Toyama College
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
National Institute of Technology, Toyama College
Address
Ebieneriya 1-2, Imizu, Toyama, Japan
Tel
+81766865100
c-ohashi@nc-toyama.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
| 2022 | Year | 07 | Month | 27 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2022 | Year | 07 | Month | 27 | Day |
Last modified on
| 2024 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055255
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