| CTRI Number |
CTRI/2026/03/105464 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
06/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Developmental and Tool validation |
| Study Design |
Other |
|
Public Title of Study
|
This study aim to develop Directive Screening of Heart Health Assessment to find people in the community who may be at risk for heart disease.” |
|
Scientific Title of Study
|
A study to develop Directive Screening of Heart Health Assessment (DiSHHA) for identifying cardiovascular risk among people residing in community of Ambala Haryana |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanjali Sharma |
| Designation |
M.Sc. Nursing Student |
| Affiliation |
Maharishi Markandeshwar College of Nursing, Maharishi Markandeshwar (Deemed to Be) University |
| Address |
Maharishi Markandeshwar College Of Nursing, Maharishi Markandeshwar (Deemed to Be) University, Mullana Ambala
pin 133203, Distt Ambala Haryana, MSN Department Room No 201
Maharishi Markandeshwar College Of Nursing, Maharishi Markandeshwar (Deemed to Be) University, Mullana Ambala
pin 133203, Distt Ambala Haryana, MSN Department. Room No 201
Ambala
HARYANA
133203
India |
| Phone |
8626959204 |
| Fax |
|
| Email |
priyanjlisharma1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Jyoti Phougat |
| Designation |
Associate Professor |
| Affiliation |
Maharishi Markandeshwar College of Nursing, Maharishi Markandeshwar (Deemed to Be) University |
| Address |
Maharishi Markandeshwar College Of Nursing, Maharishi Markandeshwar (Deemed to Be) University, Mullana Ambala
pin 133203, Distt Ambala Haryana, CHN Department Room No 210
Maharishi Markandeshwar College Of Nursing, Maharishi Markandeshwar (Deemed to Be) University, Mullana Ambala
pin 133203, Distt Ambala Haryana, CHN Department Room No 210
Ambala
HARYANA
133203
India |
| Phone |
9812836109 |
| Fax |
|
| Email |
jyotiphougat01@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Ms Jyoti Phougat |
| Designation |
Associate Professor |
| Affiliation |
Maharishi Markandeshwar College of Nursing, Maharishi Markandeshwar (Deemed to Be) University |
| Address |
Maharishi Markandeshwar College Of Nursing, Maharishi Markandeshwar (Deemed to Be) University, Mullana Ambala
pin 133203, Distt Ambala Haryana, CHN Department Room No 210
Maharishi Markandeshwar College Of Nursing, Maharishi Markandeshwar (Deemed to Be) University, Mullana Ambala
pin 133203, Distt Ambala Haryana, CHN Department Room No 210
HARYANA
133203
India |
| Phone |
9812836109 |
| Fax |
|
| Email |
jyotiphougat01@mmumullana.org |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar (Deemed to Be) University,Mullana Ambala, Maharishi Markandeshwar College of Nursing, Mullana Ambala |
|
|
Primary Sponsor
|
| Name |
Ms Jyoti Phougat |
| Address |
Maharishi Markandeshwar College Of Nursing, Maharishi Markandeshwar (Deemed to Be) University, Mullana Ambala
pin 133203, Distt Ambala Haryana, CHN Department Room No 210 |
| Type of Sponsor |
Private 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 |
| Priyanjali Sharma |
Maharishi Markandeshwar College of Nursing, Ambala Haryana |
Maharishi Markandeshwar College Of Nursing, Maharishi Markandeshwar (Deemed to Be) University, Mullana Ambala
pin 133203, Distt Ambala Haryana
MSN Department Room No 201
Maharishi Markandeshwar College Of Nursing, Maharishi Markandeshwar (Deemed to Be) University, Mullana Ambala
pin 133203, Distt Ambala Haryana
MSN Department. Room No 201
Ambala
HARYANA |
08626959204
priyanjlisharma1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maharishi Markandeshwar Institute of Medical Sciences & Research Mullana, Ambala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
For Identifying cardiovascular Risk |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age 30-60 years
Permanent resident more than 6 months and above |
|
| ExclusionCriteria |
| Details |
Diagnosed with cardiovascular disease
ANY pregnant Women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Early identification for risk of Cardiovascular Disease |
Baseline screening of community for identification of Cardiovascular Disease |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Early identification for risk of cardiovascular disease |
Baseline screening of identification of cardiovascular disease |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
20/03/2026 |
| 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="1"
Months="1"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
A study to develop Directive Screening of Heart Health Assessment (DiSHHA) for identifying cardiovascular risk among people residing in community of Ambala Haryana. In the modern workforce, the merging of the sedentary lifestyle, chronic stress, and aging demographic has led to a silent but significant rise in major public health emergency worldwide and remain the leading cause of mortality and disability of the condition. Cardiovascular disease are the major public health concern in India, and early identification of individuals at risk is essential for prevention. Existing risk assessment tools are often complex and not easily applicable in community settings. This study aims to develop and validate a Directive Screening of Heart Health Assessment (DiSHHA) tool To identify cardiovascular risk among adults residing in selected community of Haryana. The study will involve tool development, expert validation, pilot testing and assessment of reliability and validity. The DiSHHA tool is intended to provide a simple, community based screening method for early detection and referral of individuals that are more prone for the increased cardiovascular risk |