| CTRI Number |
CTRI/2024/11/077020 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
11/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Health Literacy Intervention ] |
| Study Design |
Other |
|
Public Title of Study
|
Helping People in Uttar Pradesh Learn About Heart Health |
|
Scientific Title of Study
|
Effectiveness of health literacy intervention regarding knowledge on cardiovascular diseases among adults of Uttar Pradesh |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ram Niwas |
| Designation |
Professor |
| Affiliation |
Teerthanker Mahaveer College of Nursing |
| Address |
Teerthanker Mahaveer College of Nursing, Department of Community Health Nursing, Room No 106, Delhi Road, Moradabad, Uttar Pradesh
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9548658247 |
| Fax |
|
| Email |
ramniwas.scholar@tmu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr S P Subashini |
| Designation |
Dean |
| Affiliation |
Teerthanker Mahaveer College of Nursing |
| Address |
Teerthanker Mahaveer College of Nursing, Department of Medical Surgical Nursing, Room No 101, Delhi Road
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
6399000660 |
| Fax |
|
| Email |
dean.nursing@tmu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr S P Subashini |
| Designation |
Dean |
| Affiliation |
Teerthanker Mahaveer College of Nursing |
| Address |
Teerthanker Mahaveer College of Nursing, Department of Medical Surgical Nursing, Room No 101, Delhi Road, Moradabad, Uttar Pradesh
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
6399000660 |
| Fax |
|
| Email |
dean.nursing@tmu.ac.in |
|
|
Source of Monetary or Material Support
|
| Teerthanker Mahaveer College of Nursing, Delhi Road, Moradabad, Uttar Pradesh India- 244001 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 |
| Ram Niwas |
Teerthanker Mahaveer College of Nursing |
Department of Community Health Nursing, Room No 106, Delhi Road
Moradabad
UTTAR PRADESH |
9548658247
ramniwas.scholar@tmu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Teerthanker Mahaveer University Moradabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Prone to cardiovascular diseases |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Health Literacy |
Educational intervention consisted on 45 minutes session will be delivered. The content of session is on CVD risk factors (modifiable and non-modifiable), normal and high measurements of hypertension (HTN), its complications, medication, symptoms of heart attack, symptoms of stroke and preventive practices about knowing their usual BP, use of salt and fats intake, physical activity and its frequency, smoking habit of sample adults and information seeking behavior.
|
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
Adults who are:
From 20 to 59 years of age.
Who can able to read English or Hindi.
Willing to participate in the study
Available during data collection period
|
|
| ExclusionCriteria |
| Details |
Adults who are:
Not willing to participate
Known case of Cardiovascular diseases
With any other comorbidities.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| knowledge of cardiovascular diseases |
Six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Life style changes towards health |
One Year |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
02/12/2024 |
| 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
|
Assess the baseline knowledge on
cardiovascular disease and implement a comprehensive health
literacy intervention program. Effectiveness
of health literacy intervention regarding knowledge on cardiovascular diseases
H1:-There is a significant difference between
mean pretest knowledge score and post test knowledge score of adults on cardio
vascular diseases.
H2:- There is a significant difference between
mean pretest knowledge score and post test knowledge score of adults of urban and rural areas on cardio vascular diseases.
H3:-There is a significant association between
post test knowledge score and selected demographic variables of adults on
cardiovascular diseases.
|