| CTRI Number |
CTRI/2025/02/081006 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of Voice Messages in Diabetes Management |
|
Scientific Title of Study
|
Empowering Self-Care - Assessing the Impact of Voice Message Services on Diabetes Management in Rural areas of Vizianagaram and Tirupati District – A Multicentric Interventional Study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr.B.Devi Madhavi |
| Designation |
Professor of Community Medicine |
| Affiliation |
Government Medical College,Vizianagaram |
| Address |
Room No.99, Wellness clinic, Department of Community Medicine, Government General Hospital, Government Medical College, Vizianagaram
Vizianagaram
ANDHRA PRADESH
535003
India |
| Phone |
9885193506 |
| Fax |
|
| Email |
madhavi.bhimarasetty@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.B.Devi Madhavi |
| Designation |
Professor of Community Medicine |
| Affiliation |
Government Medical College,Vizianagaram |
| Address |
Room No.99, Wellness clinic, Department of Community Medicine, Government General Hospital, Government Medical College, Vizianagaram
Vizianagaram
ANDHRA PRADESH
535003
India |
| Phone |
9885193506 |
| Fax |
|
| Email |
madhavi.bhimarasetty@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.B.Devi Madhavi |
| Designation |
Professor of Community Medicine |
| Affiliation |
Government Medical College,Vizianagaram |
| Address |
Room No.99, Wellness clinic, Department of Community Medicine, Government General Hospital, Government Medical College, Vizianagaram
Vizianagaram
ANDHRA PRADESH
535003
India |
| Phone |
9885193506 |
| Fax |
|
| Email |
madhavi.bhimarasetty@gmail.com |
|
|
Source of Monetary or Material Support
|
| ICMR NIN Beside Tarnaka Metro Station, Jamai-Osmania PO, Hyderabad-500 007, India. |
|
|
Primary Sponsor
|
| Name |
ICMR NIN |
| Address |
ICMR NIN Metro Station PO,Beside Tarnaka
Osmania university
MettugudaHyderabad/Secunderabad
Pin:500007 |
| Type of Sponsor |
Other [Goverment Research Organization under DHR] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr B Devi Madhavi |
Government General Hospital,Government Medical College, Vizianagaram |
Room No. 99, Wellness clinic, Department of Community Medicine, Government General Hospital, Government Medical college, Vizianagaram,535003
Vizianagaram
ANDHRA PRADESH |
9885193506
madhavi.bhimarasetty@gmail.com |
| Dr Sunita Sreegiri |
SVRR Government General hospital/SV Medical College |
Room no 222,Wellness clinic, Department of Community Medicine,SVRGGH, SV Medical College, Tirupati, 517507
Chittoor
ANDHRA PRADESH |
9866089393
sunita.sreegiri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Submittted/Under Review |
| Institutional Ethics Committee,Government Medical College ,Vizianagaram |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E08-E13||Diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Routine Heath advice on diabetes management |
On Medical adherence and lifestyle modifications during visit 0,visit1(after 4weeks),visit2(after 16weeks) |
| Intervention |
Voice messages through mobile phones on diabetes management |
90 seconds duration voice messages twice weekly regarding medication adherence and lifestyle modifications
Between Baseline ie visit0 to visit1(4 weeks)-eight (8) messages and
between visit 1 and visit 2(16 weeks)
twenty four (24) messages |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diabetic patients Age 30-60yrs.
Type 2 diabetic patients who were diagnosed at least in last 12 months and
Those availing Government Health Services at Health and Wellness centers for Diabetes and
Who have mobile phone or access to mobile phone and are willing to participate.
|
|
| ExclusionCriteria |
| Details |
Patients with known complications of diabetes and other co-morbidities
People with known physical handicap such as visual and hearing and limb deformities.
People who do not have access to smartphones.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assess Glycemic Control by Measuring the changes in HbA1c levels before and after the intervention in both Intervention and Control groups. |
Visit 0- Baseline to
Visit 2 -16 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
change in physical activity level
|
at one month and four months |
| change in medication adherence |
at one and four months |
| change in Diet |
at one and four months |
| change in BMI and WC |
at one and four months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
07/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
07/03/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
In chronic conditions, Treatment success is highly dependent on the level of adherence among patients. Non-adherence to medication therapy is often associated with poor treatment outcomes, high healthcare costs, poor quality of life, worsening health of the individuals, development of complications, and ultimately death. Generally, patients suffering from chronic conditions are reportedly non-adherents, with only half adhering in developed nations and a far lesser number in the developing world. According to World Health Organization (WHO), the use of mHealth through phone calls, voice, or short message services (SMS) to promotes treatment compliance and indirectly reduces drug resistance and help in diseases control/elimination . A recent Family Doctor Program (FDP) survey conducted by the Department of Community Medicine to assess the health services revealed, low utilization of health service rates despite their availability. It was noted that there is a significant lack of knowledge within the community, particularly among individuals with diabetes for both the need for medication adherence and for non pharmacological interventions such as lifestyle modifications. M-Health technologies is being widely used in programmes related to RCH and TB .However its use was not well documented in Diabetes management Hence this study was proposed to try the innovative approach of studying the effectiveness of voice messages through mobile phones in Diabetes management in rural populations of Andhrapradesh. The hypothesis is that health education through Voice messages will lead to better glycemic control |