| CTRI Number |
CTRI/2020/10/028601 [Registered on: 23/10/2020] Trial Registered Prospectively |
| Last Modified On: |
22/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
adherence and treatment satisfaction in Hypertensive patients |
|
Scientific Title of Study
|
A cross-sectional study to evaluate the adherence and treatment satisfaction of Angiotensin Receptor Blockers vs Non Angiotensin Receptor Blockers among Hypertensive Patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arshiya |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College, Patiala |
| Address |
Department of Pharmacology, Government Medical College, Patiala
Government Medical College, Patiala
Patiala
PUNJAB
147001
India |
| Phone |
09646732003 |
| Fax |
|
| Email |
arshiyasehgal26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Kumar Sehgal |
| Designation |
Professor & HOD |
| Affiliation |
Government Medical College, Patiala |
| Address |
Department of Pharmacology, Government Medical College, Patiala
Room No 1 ,Department of PharmacologyGovernment Medical College, Patiala
Patiala
PUNJAB
147001
India |
| Phone |
09646732001 |
| Fax |
|
| Email |
vijayksehgal@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arshiya |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College, Patiala |
| Address |
Department of Pharmacology, Government Medical College, Patiala
Government Medical College, Patiala
PUNJAB
147001
India |
| Phone |
09646732003 |
| Fax |
|
| Email |
arshiyasehgal26@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No 1 Department of Pharmacology, Government Medical College, Patiala, Punjab, India |
|
|
Primary Sponsor
|
| Name |
department of pharmacology |
| Address |
Government Medical College, Patiala |
| 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 |
| Dr Arshiya |
Government Medical College& Rajindra Hospital |
Room No 14, Department of Medicine,Rajindra Hospital
Patiala
PUNJAB |
09646732003
arshiyasehgal26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research &Ethics Committee,Government Medical College, Patiala |
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 |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1 Adults age > 18 years
2 Patients on monotherapy and combination of antihypertensive drugs (ARBs and other drugs)
3 Patients with HTN diagnosed and taking antihypertensive medication at least 4 months prior to start of the study
|
|
| ExclusionCriteria |
| Details |
1 Children
2 Pregnant women
3 Seriously ill and acutely ill patients
4 Patients who are not willing to give written informed consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To evaluate and compare the Medication Adherence among Hypertensive patients taking Angiotensin Receptor Blockers based regimen and other regimens.
2.To evaluate and compare the treatment satisfaction among Hypertensive patients taking Angiotensin Receptor Blockers based regimen and other regimens.
|
At 3mths
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the efficacy of the ARBs among Hypertensive patients taking ARB based regimen and other regimens by assessing the number of patients who achieved target BP
2.To evaluate the correlation between the BP, medication adherence score and treatment satisfaction score among patients taking ARBs and other regimens.
|
At 3mths |
|
|
Target Sample Size
|
Total Sample Size="164"
Sample Size from India="164"
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)
|
30/10/2020 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
INTRODUCTION - Hypertension is the most common
cardiovascular disease.Worldwide
Prevalence of hypertension exceeds 1.3 billion. The number of adults
with hypertension in
2025 was predicted
to increase by
60% ,a total
of 1.56 billion. AIMS & OBJECTIVES - To evaluate and compare the Medication
Adherence among Hypertensive
patients taking Angiotensin Receptor Blockers
based regimen and other regimens. To evaluate and compare the treatment satisfaction among Hypertensive patients taking Angiotensin Receptor Blockers based regimen and other regimens.
MATERIALS &METHODS - This observational
cross sectional study will be conducted over 164 patients,82 in each group to
evaluate the adherence and
treatment satisfaction of antihypertensive
medications in hypertensive patients. We will enroll hypertensive patients coming to department of medicine, Rajindra
Hospital attached to Govt. Medical College Patiala. The patients
fulfilling the inclusion criteria and the exclusion criteria will be included
in the study after taking the written informed consent.
Patients will be divided into two groups i.e. Group 1 involving hypertensive
patients taking ARBs in monotherapy or in combination therapy and Group 2,
involving hypertensive patients taking antihypertensive medications other than ARBs, in monotherapy or in combination therapy Adherence will be
assessed byMorisky Green and Levine Adherence Scale. Patient treatment
satisfaction will be evaluated using Treatment Satisfaction Questionnaire for
Medication (TSQM). We will also look for the number of patients who have
achieved BP control i.e. who have successfully attained the BP equal to or less
than the target BP.
RESULTS- Adherence and treatment satisfaction scores will be
calculated and compared among Group 1 and Group 2 hypertensive patients. Lastly, a correlation analysis will be done
between the BP and the adherence and treatment satisfaction scores.
|