| CTRI Number |
CTRI/2024/08/072120 [Registered on: 08/08/2024] Trial Registered Prospectively |
| Last Modified On: |
04/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Educational] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Interventional study for the assessment of medication adherence in adult hypertensive out-patients in a tertiary care hospital in rural haryana |
|
Scientific Title of Study
|
Interventional study for the assessment of medication adherence in adult hypertensive out-patients in a tertiary care hospital in rural haryana |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| EC/OA-38/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajat Bhardwaj |
| Designation |
PG Resident |
| Affiliation |
Shaheed Hasan Khan Mewati Government Medical College |
| Address |
SHKM GMC,Nalhar
Nalhar, Gehbar, Haryana 122107
Gurgaon
HARYANA
122107
India |
| Phone |
9625856969 |
| Fax |
|
| Email |
bhardwajrajat175@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Naveen Kumar |
| Designation |
Associate Professor |
| Affiliation |
Shaheed Hasan Khan Mewati Government Medical College |
| Address |
Department of Pharmacology
SHKM GMC,Nalhar
Nalhar, Gehbar, Haryana 122107
Gurgaon
HARYANA
122107
India |
| Phone |
9868257149 |
| Fax |
|
| Email |
nkk999999@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajat Bhardwaj |
| Designation |
PG Resident |
| Affiliation |
Shaheed Hasan Khan Mewati Government Medical College |
| Address |
SHKM GMC,Nalhar
Nalhar, Gehbar, Haryana 122107
Gurgaon
HARYANA
122107
India |
| Phone |
9625856969 |
| Fax |
|
| Email |
bhardwajrajat175@gmail.com |
|
|
Source of Monetary or Material Support
|
| SHKM GMC, Nalhar, Haryana ,India
122107 |
|
|
Primary Sponsor
|
| Name |
SHKM GMC |
| Address |
Nalhar, Gehbar, Haryana 122107 |
| 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 |
| Rajat Bhardwaj |
Shaheed Hasan Khan Mewati Government Medical College |
OPD Department of Medicine
Gurgaon
HARYANA |
9625856969
bhardwajrajat175@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee(Shaheed Hasan Khan Mewati Government Medical College) |
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 |
Educational Intervention |
Non-adherent patients will be randomly divided into two study groups i.e., Group A and Group B. Each study group will receive the following-.
Group A – interactive educational module on medication adherence for 1month
Group B – usual care in the medical OPD
The predesigned Educational module on medication adherence is based on the WHO literature on interventions to improve medication adherence in hypertensive patients. |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients of Essential Hypertension on oral anti-hypertensive drugs for at least 1 month visiting the medicine OPD of SHKM GMC.
Hypertensive patients on oral anti-hypertensive therapy.
Patients who are willing to give written informed consent. |
|
| ExclusionCriteria |
| Details |
Patients of secondary hypertension
Patients with severe comorbidities or cognitive impairments that may affect their ability to participate effectively
Hypertension patients on injectables.
Patients with psychiatric illness
Critically ill patients.
Pregnant and lactating women.
Patients who are not willing to give written informed consent. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To estimate the medication adherence rate among hypertensive patients at SHKM GMC
2. To evaluate the efficacy of an educational module aimed at enhancing medication compliance among non-adherent patients.
|
Baseline, After 4weeks, After 8weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To determine factors linked with adherence to oral antihypertensive medications among hypertensive outpatients at SHKM GMC.
2. To evaluate the relationship between reduction in blood pressure & adherence to oral antihypertensive medication.
3. To report Adverse drug Events to oral antihypertensive drugs
|
Baseline,4 weeks,8weeks |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
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)
|
16/08/2024 |
| 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
|
Hypertension is a major global health issue, especially in India, affecting over billion people. Poorly controlled hypertension increases the risk of serious cardiovascular events and mortality. Adherence to medication is crucial but often low due to various factors. Educational strategies such as patient education sessions and telephonic counselling can improve adherence and outcomes. However, the most effective stralegy for rural Haryana’s hypertensive patients requires specific studies considering literacy, culture and healthcare access.
Material and methods: A customized case record form will collect demographic and clinical data, including patient details, disease factors, and medication information. Face- to-face interviews and medical records will be used for data collection. The Hill-Bone Medication Adherence Scale will assess adherence.
Patients will be Categorized into adherent and non-adherent groups based on the scale. Non-adherent patients will be randomly assigned to Group A or Group B. Non-adherent patients will be divided into two groups: Group A receives an interactive educational module on medication adherence for one month, while Group B receives usual care. The efficacy of the intervention will be assessed using the Hill-Bone medication adherence scale and blood pressure measurement at baseline, first follow-up visit (short-term assessment after one month), and final follow-up after three months.
Safety will be assessed through adverse drug reaction monitoring using CDSCO reporting forms and the WHO-UMC database. Any dropouts due to adverse events will be reported and managed. |