| CTRI Number |
CTRI/2024/07/070349 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
09/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to compare the effects on Sugar control via WhatsApp based Insulin education among diabetes patients using Insulin. |
|
Scientific Title of Study
|
Impact of Insulin care and administration reinforcement education ICARE through WhatsApp messages on glycemic control among diabetes patients using insulin, attending Endocrinology OPD of a tertiary care center in Eastern India, A single blind placebo controlled parallel group block randomized trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mamta Rai |
| Designation |
Nursing Officer |
| Affiliation |
AIIMS KALYANI |
| Address |
Dept. of Endocrinology and metabolism,
AIIMS KALYANI, Basasantapur Nadia
West Bengal
Nadia
WEST BENGAL
741244
India |
| Phone |
8250049266 |
| Fax |
|
| Email |
succhalung@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
D r Ayan Roy |
| Designation |
Associate Professor |
| Affiliation |
AIIMS KALYANI |
| Address |
Dept. of Endocrinology and metabolism,
AIIMS KALYANI, Basasantapur Nadia
West Bengal
Nadia
WEST BENGAL
741245
India |
| Phone |
9432375208 |
| Fax |
|
| Email |
ayan.endocr@aiimskalyani.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Mamta Rai |
| Designation |
Nursing Officer |
| Affiliation |
AIIMS KALYANI |
| Address |
Dept. of Endocrinology and metabolism,
AIIMS KALYANI, Basasantapur Nadia
West Bengal
Nadia
WEST BENGAL
741244
India |
| Phone |
8250049266 |
| Fax |
|
| Email |
succhalung@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Kalyani,
Basantapur, Dist: Nadia
West Bengal
741245 |
|
|
Primary Sponsor
|
| Name |
AIIMS Kalyani |
| Address |
Basantapur,Nadia,West Bengal
741245 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR Ayan Roy |
AIIMS Kalyani |
4th Floor OPD building,
Dept of Endocrinology and Metabolism
Room No. 435
Nadia
WEST BENGAL |
7094019886
ayan.endocr@aiimskalyani.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee All India Institute of Medical Science, Kalyani |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E10||Type 1 diabetes mellitus, (2) ICD-10 Condition: E11||Type 2 diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Reinforcement on Insulin care and administration via WhatsApp text |
Firstly the participants knowledge will be assessed using structured questionnaire and all the data will be collected along with HbA1c value.
Participants will be grouped into two different group experimental and control. The experimental group will be receiving 4 videos on Insulin storage, identification and administration via WhatsApp bi-weekly (every Wednesday and Saturday) for 3 months. After 3 months again there knowledge will be assessed and HbA1c value will be compared. |
| Comparator Agent |
Sham text |
A sham text (greetings) will be sent bi-weekly, i.e. same as Wednesday and Saturday like for experimental group for 3 months and then there knowledge will be assessed using structured questionnaire and HbA1c level will be compared. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.All consecutive patients attending the Endocrinology and Metabolism Outpatient Department of AIIMS, Kalyani, with a known history of Diabetes Mellitus who are on insulin therapy for minimum span of 3 months.
2.Age group: 30-50 yrs
3.BMI: 23-30 kg/m2
4.Patients having HbA1c level: 7.5-12.5%
5.Patients receiving Insulin at least twice a day
6.Patients who has access to WhatsApp.
|
|
| ExclusionCriteria |
| Details |
1.Patients with known psychiatric illness and/or currently on psychiatry medications.
2.Any underlying Endocrinological disorder causing secondary diabetes mellitus such as Cushing’s disease, Acromegaly, Hyperthyroidism, type 3c diabetes.
3.Patients having secondary diabetes related to drugs like steroids, chemotherapy etc.
4.Pregnant and lactating mother up to 6 months, patients suffering from cancer and/or had a history of radiation or chemotherapy
5.DM Patients with CLD, CKD, eGFR less than 15, heart failure, any hematological disorder like beta-thalassemia etc.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It will improve the glycemic controls, knowledge and skills related to insulin care and administration |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
i. Reduction in HbA1c level.
ii. Reduction of daily Insulin dose.
|
1 year |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is a single blind placebo controlled parallel-group block randomized trial among Diabetes Mellitus patients who are on insulin therapy. The study is expecting reduction in HbA1c level, total Insulin dose per day in patients with Diabetes Mellitus as well as expected to improve Glycemic control, knowledge and Insulin administration skills of experimental group who will receive WhatsApp messages on ICARE rather than the placebo group receiving the sham messages after 3 months. |