| CTRI Number |
CTRI/2025/08/093606 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
23/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Helping people in Udupi, Karnataka, take their daily blood pressure medicine using a simple phone system. |
|
Scientific Title of Study
|
An implementation research of a technology based intervention for medication adherence among hypertensive patients in Udupi district Karnataka |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nishit Kumar Bebarta |
| Designation |
PhD Scholar |
| Affiliation |
Prasanna School of Public Health Manipal Academy of Higher Education |
| Address |
Department of Global Public Health Policy and Governance Prasanna School of Public Health
Manipal Academy of Higher Education Manipal Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
8917553227 |
| Fax |
|
| Email |
nishit.psphmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arathi P Rao |
| Designation |
Associate Professor and Head |
| Affiliation |
Prasanna School of Public Health Manipal Academy of Higher Education |
| Address |
Department of Global Public Health Policy and Governance Prasanna School of Public Health
Manipal Academy of Higher Education Manipal Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9008418848 |
| Fax |
|
| Email |
arathi.anil@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arathi P Rao |
| Designation |
Associate Professor and Head |
| Affiliation |
Prasanna School of Public Health Manipal Academy of Higher Education |
| Address |
Department of Global Public Health Policy and Governance Prasanna School of Public Health
Manipal Academy of Higher Education Manipal Udupi
KARNATAKA
576104
India |
| Phone |
9008418848 |
| Fax |
|
| Email |
arathi.anil@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Prasanna School of Public Health Manipal Academy of Higher Education Udupi Karnataka India Pincode-576104 |
|
|
Primary Sponsor
|
| Name |
Prasanna School of Public Health |
| Address |
Prasanna School of Public Health Manipal Academy of Higher Education Udupi Karnataka India Pincode-576104 |
| Type of Sponsor |
Other [Academic institution] |
|
|
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 Shashikiran U |
Department of General Medicine Dr TMA Pai Hospital |
Department of General Medicine Dr TMA Pai Hospital MAHE Udupi
Udupi
KARNATAKA |
9008418171
shashikiran.u@manipal.edu |
| Dr Kirthinath Ballala A B |
Department of General Medicine Dr. TMA Pai Rotary Hospital Karkala |
Department of General Medicine Dr. TMA Pai Rotary Hospital Karkala Udupi
Udupi
KARNATAKA |
9844270050
kirthinath.ballala@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Technology Based reminder system |
This app is designed for people with hypertension to improve medication adherence. It provides daily medication reminders, tracks doses taken, and schedules follow-up check-ins. The system ensures timely intake of medicines and consistent monitoring to support effective blood pressure management. |
| Comparator Agent |
Technology-based Educational intervention |
This app is designed for people with hypertension to promote medication adherence by providing educational content on the condition, its management, and the importance of consistent treatment. It offers easy-to-understand information on healthy lifestyle practices and the role of regular medication in controlling blood pressure. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 18 years and above with a confirmed diagnosis of hypertension by a certified medical professional, documented in medical records or through a valid prescription.
Adults diagnosed with hypertension for at least 6 months before the study and currently on antihypertensive medication.
Residents of Udupi district, Karnataka, who have been living in the district for at least the past 12 months.
Adults who have access to a mobile phone with an Android operating system.
|
|
| ExclusionCriteria |
| Details |
Adults with severe complications of hypertension like paralysis or stroke that impair their ability to participate in the study.
Pregnant women.
Adults who are not willing to participate in the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Comparison between AI-powered mHealth intervention and app-based educational intervention on medication adherence in hypertensive patients.
|
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NILL |
NILL |
|
|
Target Sample Size
|
Total Sample Size="284"
Sample Size from India="284"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
05/09/2025 |
| 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="3"
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
|
This interventional study adopts a quantitative approach to evaluate the effectiveness of two technology-based strategies for improving medication adherence among hypertensive patients in Udupi district, Karnataka. The study will be conducted in two private tertiary care hospitals, enrolling 284 eligible participants who are adults diagnosed with hypertension for at least six months and currently on antihypertensive medication. Participants will be divided into two clusters. Cluster 1 will receive an AI-powered mHealth intervention that delivers personalized medication reminders, while Cluster 2 will be provided with an app-based educational intervention focusing on hypertension management. Baseline adherence levels will be measured prior to the interventions, which will be implemented over a three-month period. Post-intervention, adherence will be reassessed to compare the impact of both approaches. The primary aim is to determine whether the AI-powered mHealth intervention is more effective than the app-based educational tool in enhancing adherence to prescribed medication among hypertensive patients. This study will contribute evidence on the role of digital interventions in strengthening chronic disease management and improving patient outcomes in a tertiary care setting. |