| CTRI Number |
CTRI/2025/11/097783 [Registered on: 20/11/2025] Trial Registered Prospectively |
| Last Modified On: |
19/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessment of Stroke Risk Among Hypertensive Patients Using the PreventS-MD Tool at a Tertiary Care Hospital in Jaipur |
|
Scientific Title of Study
|
Evaluate Stroke Risk Index among Hypertensive Patients by using PreventS-MD at a Tertiary Care Hospital in Jaipur |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chirayu Pareek |
| Designation |
Third Year MBBS Student |
| Affiliation |
RUHS Hospital, Jaipur |
| Address |
Room No. 101, Department of Physiology, Sector 11 Rd, Kumbha Marg, Sector 11, Pratap Nagar, Jaipur
Jaipur
RAJASTHAN
302033
India |
| Phone |
8824989179 |
| Fax |
|
| Email |
pareekchirayu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha Saboo |
| Designation |
Professor of Physiology |
| Affiliation |
RUHS Hospital, Jaipur |
| Address |
Room No 101, Department of Physiology, Sector 11 Rd, Kumbha Marg, Sector 11, Pratap Nagar, Jaipur
Jaipur
RAJASTHAN
302033
India |
| Phone |
8302437849 |
| Fax |
|
| Email |
nehasaboo8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chirayu Pareek |
| Designation |
Third Year MBBS Student |
| Affiliation |
RUHS Hospital, Jaipur |
| Address |
Room No. 5, Department of Medicine, Sector 11 Rd, Kumbha Marg, Sector 11, Pratap Nagar, Jaipur
Jaipur
RAJASTHAN
302033
India |
| Phone |
8824989179 |
| Fax |
|
| Email |
pareekchirayu@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
RUHS College of Medical Sciences Jaipur |
| Address |
Sector 11 Rd, Kumbha Marg, Pratap Nagar,Tonk Road,Jaipur, Rajasthan 302033, India |
| 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 Neha Saboo |
RUHS Hospital |
Room No. 5, Department of Medicine, Sector 11 Rd, Kumbha Marg, Sector 11, Pratap Nagar, Jaipur, Rajasthan 302033, India
Jaipur
RAJASTHAN |
8302437849
nehasaboo8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RUHS CMS-ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I482||Chronic atrial fibrillation, (2) ICD-10 Condition: E78||Disorders of lipoprotein metabolism and other lipidemias, (3) ICD-10 Condition: R73||Elevated blood glucose level, (4) ICD-10 Condition: I10||Essential (primary) hypertension, (5) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Stroke Risk Assessment using the PreventS-MD Tool |
The intervention uses the PreventS-MD tool to assess stroke risk in hypertensive patients by collecting key clinical and lifestyle data (age, sex, blood pressure, comorbidities, smoking, physical activity, treatment adherence). It generates an individualized Stroke Risk Index and categorizes patients into low, moderate, or high-risk groups. Targeted recommendations focus on primary stroke prevention through optimal BP control, lifestyle modification (diet, exercise, smoking cessation), adherence to antihypertensive therapy, and early detection of additional risk factors to prevent a first-ever stroke. The full intervention is delivered over a 12-month period with assessments at baseline, 3, 6, 9, and 12 months. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to give informed consent form.
Patients with BP equal/more than 140 and 90 mmHg |
|
| ExclusionCriteria |
| Details |
Prior history of Stroke, Transient Ischemic Attack (TIA), or other neurological disorders.
Prior history of coronary heart disease (CHD) or myocardial infarction (MI).
Pregnant or lactating women.
Patients with Type 1 Diabetes Mellitus.
Participants who do not complete the PreventS-MD questionnaire or provide incomplete data. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To calculate stroke risk index among hypertensive patients by using PreventS-MD
MD |
To calculate stroke risk index among hypertensive patients by using PreventS-MD- baseline , 3, 6, 9 and 12 month follow up.
MD |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To raise awareness about hypertension & cardiovascular risk factors.
2. To promote early detection for stroke prevention in hypertensive patients. |
Outcomes will be assessed at baseline, 3 months, 6 months, 9 months, & 12 months.
1. To raise awareness about hypertension & cardiovascular risk factors, assessed at baseline, 3, 6, 9, & 12 months.
2. To promote early detection for stroke prevention in hypertensive patients, assessed at baseline, 3, 6, 9, & 12 months. |
|
|
Target Sample Size
|
Total Sample Size="295"
Sample Size from India="295"
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)
|
01/12/2025 |
| 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="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
|
This study aims to evaluate stroke risk among hypertensive adults attending a tertiary care hospital in Jaipur using the PreventS-MD assessment tool. The tool collects clinical and lifestyle information to generate a Stroke Risk Index and classify participants into risk categories. The study also incorporates primary prevention measures by identifying modifiable risk factors and providing guidance on blood pressure control, treatment adherence, and lifestyle modification to help prevent a first-ever stroke.
|