UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054044 |
|---|---|
| Receipt number | R000061691 |
| Scientific Title | Impact of diabetes conversation map toolkit on self-care management, treatment adherence and glycemic control among type 2 diabetic patients |
| Date of disclosure of the study information | 2024/04/03 |
| Last modified on | 2024/10/04 03:07:08 |
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Basic information
Public title
Impact of diabetes conversation map toolkit on self-care management, treatment adherence and glycemic control among type 2 diabetic patients
Acronym
Impact of diabetes conversation map toolkit on self-care management, treatment adherence and glycemic control among type 2 diabetic patients
Scientific Title
Impact of diabetes conversation map toolkit on self-care management, treatment adherence and glycemic control among type 2 diabetic patients
Scientific Title:Acronym
Impact of diabetes conversation map toolkit on self-care management, treatment adherence and glycemic control among type 2 diabetic patients
Region
| Africa |
Condition
Condition
Diabetes Mellitus
Classification by specialty
| Endocrinology and Metabolism | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the Impact of diabetes conversation map toolkit on self-care management, treatment adherence and glycemic control among type 2 diabetic patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Self-care management
Treatment adherence
Glycemic control
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants 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
The intervention group will receive eight diabetes conversation map sessions for 8 consecutive weeks.
Interventions/Control_2
The control group is entrusted with standard routine care
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
| 25 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Confirmed diagnosis of type 2 diabetes mellitus
At least 6 months on diabetes therapy
Willing to participate in the study for 3 months
Key exclusion criteria
Patients with Type 1 diabetes
Patients less than 20 years old
Target sample size
225
Research contact person
Name of lead principal investigator
| 1st name | Shaimaa |
| Middle name | |
| Last name | Amin |
Organization
Faculty of Nursing
Damanhour University
Division name
Community Health Nursing
Zip code
22511
Address
El gomhoureya St., beside the hospital damanhour general, damanhour, beheira. Damanhour Beheira
TEL
+201007180212
shaimaa.amin12@yahoo.com
Public contact
Name of contact person
| 1st name | Eman |
| Middle name | |
| Last name | Ghallab |
Organization
Faculty of Nursing Alexandria University
Division name
Nursing Education
Zip code
21568
Address
Izbat Saed, Sidi Gaber, Alexandria Governorate
TEL
+201200445532
Homepage URL
eman.ghallab@alexu.edu.eg
Sponsor or person
Institute
Damanhour University
Institute
Department
Personal name
Funding Source
Organization
Not applicable
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
Research Ethics Committee of the Faculty of Nursing in Damanhour University
Address
El gomhoureya St., beside the hospital damanhour general, damanhour, beheira. Damanhour Beheira
Tel
+20 45 3311679
admin.nur@nur.dmu.edu.eg
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 | 04 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
we are still analyzing the data
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
Completed
Date of protocol fixation
| 2021 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 05 | 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 | 04 | Month | 03 | Day |
Last modified on
| 2024 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061691
