| CTRI Number |
CTRI/2025/08/093916 [Registered on: 29/08/2025] Trial Registered Prospectively |
| Last Modified On: |
29/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of Voice Messages reminders to Patients with Diabetes in reducing their blood sugar levels. |
|
Scientific Title of Study
|
Effectiveness of Voice Message Services for promoting self-care among people with Diabetes attending Urban Health Centres in Kakinada district- An 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 |
Padamata Pavana Krishna |
| Designation |
Postgraduate |
| Affiliation |
Rangaraya Medical College |
| Address |
Department of Community Medicine, Government General Hospital, Rangaraya Medical College, Kakinada
East Godavari
ANDHRA PRADESH
533003
India |
| Phone |
9100763285 |
| Fax |
|
| Email |
pavanakrishna1234@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Sujatha |
| Designation |
Professor and Head of the Department |
| Affiliation |
Rangaraya Medical College |
| Address |
Department of Community Medicine, Government General Hospital, Rangaraya Medical College, Kakinada
East Godavari
ANDHRA PRADESH
533003
India |
| Phone |
9849548293 |
| Fax |
|
| Email |
trisuj@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Padamata Pavana Krishna |
| Designation |
Postgraduate |
| Affiliation |
Rangaraya Medical College |
| Address |
Department of Community Medicine, Government General Hospital, Rangaraya Medical College, Kakinada
East Godavari
ANDHRA PRADESH
533003
India |
| Phone |
09100763285 |
| Fax |
|
| Email |
pavanakrishna1234@gmail.com |
|
|
Source of Monetary or Material Support
|
| 1 District Medical and Health Office, Kakinada, East Godavari, Andhra Pradesh,533003, India
2 Rangaraya Medical College, Kakinada, East Godavari, Andhra Pradesh, 533001, India |
|
|
Primary Sponsor
|
| Name |
Padamata Pavana Krishna |
| Address |
Department of Community Medicine Government General Hospital, Rangaraya Medical College, Kakinada, East Godavari,533003, Andhra Pradesh, India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of Health Research ICMR Pg Thesis |
Government of India Ministry of Health and Family Welfare Department of Health Research |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Padamata Pavana Krishna |
Government General Hospital |
Department of Community Medicine, Government General Hospital, Rangaraya Medical College, Kakinada,533003
East Godavari
ANDHRA PRADESH |
9100763285
pavanakrishna1234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rangaraya Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E109||Type 1 diabetes mellitus without complications, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mobile Voice Messages |
Voice messages of 1.5 min about dietary advice, physical activity, and Medication adherence will be sent weekly two times for 6 months to the mobile phones of intervention group. |
| Comparator Agent |
With out Mobile Voice Messages |
will be given standard care advices regarding dietary advices, physical activity, medication adherence |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Type 1 and Type 2 diabetic patients who were diagnosed at least in last 6 months
Who have mobile phone or access to mobile phone and are Willing to participate
|
|
| ExclusionCriteria |
| Details |
Patient with complication of diabetes.
People with known physical handicap such as visual and hearing and limb deformities
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Glycemic control measured by Random Blood Sugar (RBS) levels |
Baseline,3rd month from baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Medication adherence
2.Adherence to dietary modifications
3.Adherence to physical activity
4.Body Mass Index (BMI)
5.Waist circumference |
Baseline,1st month from baseline,3rd month from baseline |
|
|
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)
|
22/09/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This study is a randomized, open ended, parallel group, single centre community base trial comparing effectiveness of voice message services for promoting self care in 200 patients diagnosed with diabetes in the last six months will be conducted in different UPHS in Urban areas of Kakinada district of Andhra Pradesh state. The primary outcome will be glycemic control which will be estimated by Random blood sugar levels at baseline, 3 months from baseline. |