UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053648 |
|---|---|
| Receipt number | R000061216 |
| Scientific Title | Mobile Application-based Intervention for Individuals with Type 2 Diabetes: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2024/02/20 |
| Last modified on | 2024/02/19 18:34:18 |
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Basic information
Public title
Mobile App for Type 2 Diabetes: A Randomized Controlled Trial
Acronym
MADI-T2D
Scientific Title
Mobile Application-based Intervention for Individuals with Type 2 Diabetes: A Randomized Controlled Trial
Scientific Title:Acronym
MADI-T2D: A RCT
Region
| Japan |
Condition
Condition
Type 2 Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effectiveness of a mobile app-based health intervention focused on enhancing diabetes knowledge, on health behaviors among individuals with type 2 diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Health behavior (at baseline and follow-up period)
Key secondary outcomes
Diabetes knowledge, Beliefs about diabetes management, Self-efficay, Glycated hemoglobin level, Quality of life (at baseline, follow-up period, and 3 months after)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group (WhatsApp: receive free illustrated messages through WhatsApp about diabetes knowledge, such as definition, pathophysiology, etiology, prevention of complications, foot care, etc. for approximately six weeks until a maximum of two months / Control group (standard care: receive standard care from health center).
Interventions/Control_2
Intervention group (WhatsApp: receive free illustrated messages through WhatsApp about diabetes knowledge, such as definition, pathophysiology, etiology, prevention of complications, foot care, etc. for approximately six weeks until a maximum of two months / Control group (standard care: receive standard care from health center).
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Individuals diagnosed with type 2 diabetes
2) Aged 18 and over
3) Those with smartphone ownership
4) Those actively using WhatsApp
5) Those taking diabetes medication
6) Having at least one HbA1c test higher or equal to 6.5% during the past three months
7) Those who are willing to participate
Key exclusion criteria
1) Those who experience deafness and illiteracy
2) Unable to read and speak Indonesian
3) Those with diabetes complications
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Citra |
| Middle name | Gabriella |
| Last name | Mamahit |
Organization
St. Luke's International University
Division name
Globbal Health Nursing
Zip code
104-0044
Address
10-1 Akashicho, Chuo City, Tokyo
TEL
03-3543-6391
22dn015@slcn.ac.jp
Public contact
Name of contact person
| 1st name | Citra |
| Middle name | Gabriella |
| Last name | Mamahit |
Organization
St. Luke's International University
Division name
Global Health Nursing
Zip code
104-0044
Address
10-1 Akashicho, Chuo City, Tokyo
TEL
03-3543-6391
Homepage URL
22dn015@slcn.ac.jp
Sponsor or person
Institute
St. Luke's International University
Institute
Department
Personal name
Funding Source
Organization
St. Luke's Health Science Research Fund 2023
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Sam Ratulangi University-Indonesia, Manado City Health Department-Indonesia
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Luke's International University
Address
10-1 Akashicho, Chuo City, Tokyo
Tel
03-3543-6391
22dn015@slcn.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
| 2024 | Year | 02 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 02 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 30 | 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 | 02 | Month | 19 | Day |
Last modified on
| 2024 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061216
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| Registered date | File name |
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| Registered date | File name |
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