| CTRI Number |
CTRI/2026/02/104097 [Registered on: 17/02/2026] Trial Registered Prospectively |
| Last Modified On: |
16/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of supportive education on BP, Medication adherence and quality of life of hypertensive patients |
|
Scientific Title of Study
|
The effectiveness of health literacy based self-management support intervention on Blood pressure control, Medication adherence and quality of life among hypertensive patients visiting Dommasandra PHC, Bangalore |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tenzin Bhutti |
| Designation |
7 Semester BSc Nursing student |
| Affiliation |
Krupanidhi College of Nursing |
| Address |
Department of medical surgical nursing , Department office , Krupanidhi college of Nursing , No.12/1, Chikkabellandur,Varthur Hobli, Carmeleram PO
Department of medical surgical nursing, Department office Krupanidhi college of Nursing , No.12/1, Chikkabellandur,Varthur Hobli, Carmeleram PO
Bangalore
KARNATAKA
560035
India |
| Phone |
6006846814 |
| Fax |
|
| Email |
tenzinbhutti6051@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prabha Lis Thomas |
| Designation |
Vice principal |
| Affiliation |
Krupanidhi College of Nursing |
| Address |
Department of medical surgical Nursing, Department office , Krupanidhi college of nursing,No.12/1,Chikkabellandur,Varthur Hobli,Carmelaram PO, Bangalore 560035
Department of medical surgical Nursing, Department office Krupanidhi college of nursing,No.12/1,Chikkabellandur,Varthur Hobli,Carmelaram PO, Bangalore 560035
Bangalore
KARNATAKA
560035
India |
| Phone |
09886451011 |
| Fax |
|
| Email |
pabha0575@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prabha Lis Thomas |
| Designation |
Vice principal |
| Affiliation |
Krupanidhi College of Nursing |
| Address |
Department of Medical surgical Nursing, Department office, Krupanidhi college of nursing,Chikkabellandur, Varthur hobli, Carmelaram PO ,Bangalore
Department of Medical surgical Nursing, Department office, Krupanidhi college of nursing,Chikkabellandur, Varthur hobli, Carmelaram PO ,Bangalore
Bangalore
KARNATAKA
560035
India |
| Phone |
09886451011 |
| Fax |
|
| Email |
pabha0575@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajiv Gandhi University of Health Sciences, Bangalore |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi University of Health Sciences |
| Address |
4th T block, Jayanagar ,Bangalore -560041 |
| Type of Sponsor |
Other [Government university] |
|
|
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 Jay Bharthi |
Dommasandra PHC |
Medical officer room, Administraive office, PHC, Sarjapura Main Road, Dommasandra Village,
Anekal Taluk, Bengaluru Urban District,
Karnataka – 562125
Bangalore
KARNATAKA |
9731751320
phcdommasandra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RV COLLEGE OF NURSING |
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 |
| Comparator Agent |
standard care |
Participants allocated to the active control group will receive routine hypertension care provided, including regular medical consultations, prescription of antihypertensive medications, and general lifestyle advice as per standard guidelines. |
| Intervention |
Health literacy based self-management support intervention |
Health literacy based self-management support interventions refers to the process of equipping the individual with the knowledge, skill and attitude necessary to take care of their physical, emotional, mental and spiritual wellbeing based on the health literacy index. Supportive interventions include education through individual and group discussion, micro learning strategy and awareness, lifestyle modifications, medication adherence support, goal setting intervention to share problem solving and coping strategy to navigate health challenges, self-monitoring and tracking, continuous support and follow up, and family and community engagement and health tools. It will be delivered through group sessions, one by one counselling and lectures. These interventions are planned for 8 weeks. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Hypertensive patients at Dommasandra PHC who are;
Within the age of 30–80 years
on antihypertensive medication for at least 6 months,
- Able to communicate in English/Hindi/Kannada
-Willing to participate in the study
-Mentally competent to comprehend the instructions
available for the entire intervention and follow-up period
diagnosed with primary (essential) hypertension |
|
| ExclusionCriteria |
| Details |
Patients diagnosed with secondary hypertension.
Patients with severe complications of hypertension, such as recent stroke, myocardial infarction, heart failure, or end-stage renal disease.
Patients with severe cognitive impairment, psychiatric illness, or hearing/speech difficulties that may interfere with understanding the intervention.
Pregnant or lactating women, due to different blood pressure management protocols.
Patients currently participating in another structured hypertension education or self-management program.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Blood pressure ,Medication adherence and quality of life |
Baseline and at the end of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
02/03/2026 |
| 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="3"
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
|
Hypertension is a major non-communicable disease and a leading cause of cardiovascular deaths globally and in India. Despite being preventable and treatable, hypertension remains poorly controlled; only 12% of affected Indians achieve normal blood pressure. Limited awareness, poor medication adherence, and low health literacy are major contributors to uncontrolled hypertension. Self-management practices—such as medication compliance, dietary modification, physical activity, salt restriction, stress reduction, and regular BP monitoring—are essential in preventing complications like heart attack, stroke, and kidney failure. Health literacy strongly influences these behaviours, as patients with better understanding are more likely to follow treatment plans. Tailoring education and support to a patient’s literacy level has been shown to significantly improve BP control and treatment adherence. This study aims to determine the effectiveness of a health literacy–based self-management support intervention for hypertensive patients visiting Dommasandra PHC, Bangalore. Using a true experimental pre-test/post-test design, hypertensive adults aged between 30 and 80 years will be randomly assigned to intervention and control groups. Health literacy levels of each subject will be screened and interventions to promote self-care will be administered to the experimental group according to their health literacy for a duration of 8 weeks. BP, medication adherence, and quality of life will be assessed using validated tools before and after the intervention. The intervention includes individualized education, lifestyle guidance, medication support, reminders, self-monitoring, goal setting, and counselling. Data will be analysed using descriptive and inferential statistics The literacy-tailored self-management support intervention is expected to result in significant improvement in blood pressure control, medication adherence, and overall quality of life among hypertensive patients. By customizing the supportive interventions based on individual health literacy levels, this approach fosters better understanding, active engagement in treatment, and long-lasting self-care behaviours. If proven effective, this intervention may provide a sustainable framework for reducing hypertension-related morbidity and mortality in community-based hypertension control programs, contributing to enhanced primary health-care outcomes |