UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062882 |
|---|---|
| Receipt number | R000071995 |
| Scientific Title | Effectiveness of Telenursing for Self-management Education focused on Diabetes Mellitus: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/09/11 |
| Last modified on | 2026/09/11 18:24:25 |
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Basic information
Public title
Effectiveness of Telenursing for Self-management Education focused on Diabetes Mellitus.
Acronym
Telenursing SELF_DM RCT
Scientific Title
Effectiveness of Telenursing for Self-management Education focused on Diabetes Mellitus:
A Randomized Controlled Trial
Scientific Title:Acronym
TEL-SMED DM RCT
Region
| Asia(except Japan) |
Condition
Condition
A tailored health education program is planned to provide health education to the participants. The inclusion criteria will be strictly followed.
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study aims to evaluate the effectiveness of telenursing self-management education for people living with diabetes at primary care settings in Bangladesh.
Basic objectives2
Others
Basic objectives -Others
Improvement of self-management behaviors.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in health management behavior (baseline, 3 months and 6 months)
Key secondary outcomes
Knowledge (baseline, 3 months and 6 months)
Self-efficacy(baseline, 3 months and 6 months)
Physiological Parameters; Height, Weight, Body Mass Index, HbA1c (baseline, 3 months and 6 months)
Qualitative data regarding satisfaction and barrier ( 6th month)
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
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention- At the baseline, group education will be provided using education materials. 1st month weekly telenursing education, 2nd-3rd month bi-weekly and end of the 3rd month another group education will be provided. For next 3 months (4, 5, and 6M) phone call will be provided bi-weekly. End of 6th month group education will be provided (total 6 months intervention).
Interventions/Control_2
The control group will receive no intervention. However, they will receive one group education at the baseline with education booklet.
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Who has been diagnosed with type 2 diabetes (have diabetes for at least 3 months)
2.Both sexes (male and female)
3.Age18-60 years old
4.Who will have a smartphone or mobile phone
5.Who are willing to participate/give us the consent
Key exclusion criteria
1.Patients who have been diagnosed as Type 1 and gestational diabetes
2.Patients whose diabetes are secondary causes
3.Patients who have Sign/symptoms of severe complication of CKD (stage 4) (oedema, on dialysis)
4.Disabled person who need other person support for daily living
5.Who has physical (deaf, blind, unable to speak) and cognitive disability
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | LUCY |
| Middle name | |
| Last name | MONDOL |
Organization
Graduate School of Biomedical and Health Sciences, Hiroshima University, Japan
Division name
Chronic Care and Family Nursing Lab, Integrated Health Sciences
Zip code
734-8553
Address
Kasumi 1-2-3, Minami-ku, Hiroshima City, Japan
TEL
+81-82-257-5367
gccn.lucymondol@gmail.com
Public contact
Name of contact person
| 1st name | LUCY |
| Middle name | |
| Last name | MONDOL |
Organization
Graduate School of Biomedical and Health Sciences, Hiroshima University, Japan
Division name
Chronic Care and Family Nursing Lab, Integrated Health Sciences
Zip code
734-8553
Address
Kasumi 1-2-3 , Minami-ku, Hiroshima City, Japan
TEL
+81-82-257-5367
Homepage URL
gccn.lucymondol@gmail.com
Sponsor or person
Institute
Graduate School of Biomedical and Health Sciences, Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Chronic Care and Family Nursing Lab, Graduate School of Biomedical and Health Sciences, Hiroshima University
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
NSU Institutional Review Board/Ethics Review Committee (NSU IRB/ERC), North South University
Address
Plot-15, Bashundhara, Dhaka-1229, Bangladesh
Tel
+880-2-55668200
registrar@northsouth.edu
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
| 2026 | Year | 09 | Month | 11 | 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
| 2026 | Year | 09 | Month | 08 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 03 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2027 | 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
| 2026 | Year | 09 | Month | 11 | Day |
Last modified on
| 2026 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071995
