UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054844 |
|---|---|
| Receipt number | R000061730 |
| Scientific Title | A Single-Center Prospective Intervention Study Using Wearable Devices on Interstitial Lung Disease study |
| Date of disclosure of the study information | 2024/07/14 |
| Last modified on | 2024/07/16 12:17:41 |
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Basic information
Public title
A Single-Center Prospective Intervention Study Using Wearable Devices on Interstitial Lung Disease study
Acronym
WILD study
Scientific Title
A Single-Center Prospective Intervention Study Using Wearable Devices on Interstitial Lung Disease study
Scientific Title:Acronym
WILD study
Region
| Japan |
Condition
Condition
interstitial lung disease
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluating the feasibility of daily condition monitoring for patients with interstitial lung disease and healthy individuals using wearable devices.
Basic objectives2
Others
Basic objectives -Others
To evaluating the feasibility of daily condition monitoring for patients with interstitial lung disease and healthy individuals using wearable devices.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Compliance rate of wearable devices in patients with interstitial lung disease and healthy subjects.
Key secondary outcomes
In patients with interstitial lung disease and healthy individuals, the following comparisons will be made.
1. The relationship between self reported Quality of Life during activity and fluctuations in oxygen saturation and heart rate.
2. The amount of activity during physical exertion.
3. The relationship between daily activity and self reported Quality of Life.
4. Long term individual variability in wearable device data.
5. Variations in heart rate variability and oxygen saturation during sleep.
6. The relationship between auscultation data and physicians' auscultation findings.
7. Exercise adherence rate.
8. Completion rate and results of the questionnaire regarding subjective symptoms and the use of wearable devices.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Participants will wear a wrist-worn wearable device and a pulse oximeter for two months from the start of the study. During the study period, participants will perform the 1-minute sit-to-stand test at least three times a week at their homes. Participants will have be their auscultation sounds recorded using a stethoscope-type microphone at the time of enrollment, one month later, and two months later.
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- Individuals diagnosed with interstitial lung disease at the time of enrollment, who are expected to survive for the duration of the study and are capable of exercising at home, or individuals judged to be healthy based on the results of a health check-up.
- Individuals who are 40 years or older at the time of enrollment.
- Individuals who own and can use a smartphone capable of installing the wearable device's app.
- Individuals who have consented to participate in this study, or participants of a previously conducted study by TechDoctor Inc. who have consented to the secondary use of their data.
Key exclusion criteria
(1) Individuals who are not scheduled to undergo various tests, such as pulmonary function tests, conducted in this study.
(2) Individuals who are undergoing home oxygen therapy or who may require it during the study period.
(3) Individuals who have undergone lung resection surgery greater than a lobectomy by the time of enrollment.
(4) Individuals for whom sufficient consultation and examinations to diagnose interstitial lung disease are not planned.
(5) Individuals who cannot continuously wear wearable devices due to skin diseases or similar conditions.
(6) Individuals whom the attending physician has deemed inappropriate for participation in this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Taiki |
| Middle name | |
| Last name | Furukawa |
Organization
Nagoya University Hospital
Division name
Medical IT Center
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
+81-52-744-1977
furukawa.taiki.u7@f.mail.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Taiki |
| Middle name | |
| Last name | Furukawa |
Organization
Nagoya University Hospital
Division name
Medical IT Center
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
+81-52-744-1977
Homepage URL
furukawa.taiki.u7@f.mail.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
TECH DOCTOR Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Clinical Research Review Board
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
Tel
+81-52-744-2111
ethics@med.nagoya-u.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
名古屋大学医学部附属病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 14 | 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
| 2024 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 14 | Day |
Last follow-up date
| 2025 | Year | 01 | 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
| 2024 | Year | 07 | Month | 01 | Day |
Last modified on
| 2024 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061730
