UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052113 |
|---|---|
| Receipt number | R000059479 |
| Scientific Title | A pilot RCT of the Efficacy of Appetite monitoring in Glucocorticoid-requiring systemic Lupus Erythematosus and the Interrelationship between activity level, appetite, and mood |
| Date of disclosure of the study information | 2023/09/10 |
| Last modified on | 2025/05/09 22:46:52 |
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Basic information
Public title
Study of Appetite Monitoring among Patients with systemic Lupus Erythematosus
Acronym
SAMPLE
Scientific Title
A pilot RCT of the Efficacy of Appetite monitoring in Glucocorticoid-requiring systemic Lupus Erythematosus and the Interrelationship between activity level, appetite, and mood
Scientific Title:Acronym
EAGLE-I
Region
| Japan |
Condition
Condition
systemic lupus erythematosus
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of appetite monitoring applications in controlling the number of mealtimes and loss of appetite control.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of mealtimes on day 14 after starting the study
Key secondary outcomes
Loss of control before eating on day 14 after starting the study
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Graphical presentation of feedback of loss of control over eating and the number of eating for 14 days
Interventions/Control_2
No graphical presentation
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Patients diagnosed with SLE based on ACR 1997 classification criteria
(2) Patients scheduled to receive corticosteroid therapy
(3) Patients who have agreed to participate in this study
Key exclusion criteria
(1) Patients with neuropsychiatric lupus presenting with seizures, confusion, disorientation or delusion
(2) Patients already on corticosteroid therapy
(3) Patients who have not used the smartphone application LINE
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Noriaki |
| Middle name | |
| Last name | Kurita |
Organization
Fukushima Medical University Hospital
Division name
Department of Innovative Research and Education for Clinicians and Trainees
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima City, Fukushima Prefecture
TEL
024-547-1470
kuritan@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Noriaki |
| Middle name | |
| Last name | Kurita |
Organization
Fukushima Medical University Hospital
Division name
Department of Innovative Research and Education for Clinicians and Trainees
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima City, Fukushima Prefecture
TEL
024-547-1470
Homepage URL
kuritan@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Committee Section, Division of Medical Research Promotion, Administrative Office, Fukushima Medical University
Address
1 Hikarigaoka, Fukushima City, Fukushima Prefecture
Tel
024-547-1825
rs@fmu.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 | 09 | Month | 10 | 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
| 2023 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 05 | Day |
Last modified on
| 2025 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059479
