UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044870 |
|---|---|
| Receipt number | R000051249 |
| Scientific Title | Evaluation of a telemedicine approach in the care of patients with systemic lupus erythematosus |
| Date of disclosure of the study information | 2021/08/01 |
| Last modified on | 2023/01/15 10:10:59 |
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Basic information
Public title
Evaluation of a telemedicine approach in the care of patients with systemic lupus erythematosus
Acronym
Evaluation of a telemedicine approach in the care of patients with systemic lupus erythematosus
Scientific Title
Evaluation of a telemedicine approach in the care of patients with systemic lupus erythematosus
Scientific Title:Acronym
Evaluation of a telemedicine approach in the care of patients with systemic lupus erythematosus
Region
| Japan |
Condition
Condition
Systemic lupus erythematosus (SLE)
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To obtain initial knowledge about the significance and issues of telemedicine for SLE patients.
We will conduct a questionnaire survey of patients and physicians who have undergone medical treatment using telemedicine.
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Contents of "Questionnaire on satisfaction with and issues related to telemedicine systems (for patients)"
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
The telemedicine system will be YaDoc, an online medical system from Integrity Healthcare. Patients will install and use the systemic lupus erythematosus symptom management program (application name "YaDoc") on their smartphones.
Online medical care will be conducted at 8 weeks and 24 weeks after the start of the study. Face-to-face medical care will be conducted at 16 and 32 weeks. Patients will be asked to fill out ePROs (LupusQoL every 4 weeks and free comments on symptoms every 2 weeks) about their symptoms associated with SLE using the application between the study visits.
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
Patients must meet all of the following requirements to be considered for entry into the study:
1. Patients with SLE under treatment at Nagasaki University
2. Patients >=20 years old
3. Not concurrent use of a corticosteroid equivalent to >10 mg/day of prednisolone
4. SLEDAI less than 5
5. Patients without active organ legions
6. Patients or a family member has a smartphone
7. Ability and willingness to provide written informed consent and comply with the requirements of the study protocol
Key exclusion criteria
The exclusion criteria are as follows:
(1) Patients who are unable or unwilling to use the required online medical system.
(2) Inappropriateness for inclusion in this study as determined by the .
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Kawakami |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Immunology and Rheumatology
Zip code
8528501
Address
1-7-1 Sakamoto, Nagasaki, Nagasaki, 852-8501, Japan
TEL
095-819-7260
atsushik@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshimasa |
| Middle name | |
| Last name | Shimizu |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Immunology and Rheumatology
Zip code
8528501
Address
1-7-1 Sakamoto, Nagasaki, Nagasaki, 852-8501, Japan
TEL
095-819-7262
Homepage URL
t.shimizu@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University Graduate School of Biomedical Sciences
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital Clinical Research Ethics Committee
Address
1-7-1 Sakamoto, Nagasaki, Nagasaki, 852-8501, Japan
Tel
095-819-7229
gaibushikin@ml.nagasaki-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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 07 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2021 | Year | 07 | Month | 15 | Day |
Last modified on
| 2023 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051249
