| CTRI Number |
CTRI/2024/03/063551 [Registered on: 04/03/2024] Trial Registered Prospectively |
| Last Modified On: |
02/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assess the knowledge of heart disease risk factors. |
|
Scientific Title of Study
|
A descriptive study to assess the knowledge of cardiovascular disease CVD risk factors among adults of selected villages of Udupi Taluk |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pradeep Panduranga Nayak |
| Designation |
Student |
| Affiliation |
Manipal college of nursing MAHE Manipal |
| Address |
2nd year PBBSc Nursing department of Nursing, 1st floor Room no 105,
Manipal College Of Nursing
MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9148743656 |
| Fax |
|
| Email |
pradeepnayak3656@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Maria Pais |
| Designation |
Assistant Professor |
| Affiliation |
Manipal college of nursing MAHE Manipal |
| Address |
Department of obstretics and gyneacology 3rd floor, room no 303, Manipal College of Nursing, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9880873560 |
| Fax |
|
| Email |
maria.v@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Pradeep Panduranga Nayak |
| Designation |
Student |
| Affiliation |
Manipal college of nursing MAHE Manipal |
| Address |
2nd year PBBSc Nursing Department of nursing 1st floor Room no 105
Manipal College Of Nursing
MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9148743656 |
| Fax |
|
| Email |
pradeepnayak3656@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal College of Nursing, MAHE, Manipal |
|
|
Primary Sponsor
|
| Name |
Pradeep Panduranga Nayak |
| Address |
2nd year PBBSc Nursing
Manipal College of Nursing
MAHE Manipal |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Pradeep panduranga Nayak |
Bommarabettu |
Bommarabettu village Hiriyadka 576113
Udupi
KARNATAKA |
9148743656
pradeepnayak3656@gmail.com |
| Mrs Jayanthi |
Bommarabettu (Community Bommarabettu grama Panchayath) based study. |
Bommarabettu Grama Panchayath Office, NH 169 A, Hiriadka, Udupi District, Karnataka.
Udupi
KARNATAKA |
9632063935
bommarabettugp@gmail.com |
| Mrs jayanti the president of Grama Panchayat |
Bommarabettu it is a descriptive survey not a intervention |
Bommarabettu Grama Panchayat Office, NH 169 A, Hiriyadka, Udupi District, Karnataka
Udupi
KARNATAKA |
9632063935
bommarabettugp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee 2 Student Research |
Approved |
| Panchayat Permission Letter |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
general population age group 19- 60 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adults between age group 19-60 years
Adults willing to participate in the study
Those who are available at the time of data collection
Residence of rural areas of Udupi taluk |
|
| ExclusionCriteria |
| Details |
Adults who are not available at the time of data collection
Not the residents of rural areas of Udupi Taluk |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assess the knowledge of Cardio vascular risk factors |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Knowledge gained benefit to the society. |
Knowledge, Risk |
| Findings of the study will be used for educating the adults lifestyle modification. |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="422"
Sample Size from India="422"
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)
|
12/03/2024 |
| 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
|
This study is descriptive survey cross sectional survey design which is done for the adult population living in Udupi Taluk to assess the knowledge of cardiovascular disease risk factors the primary outcome of this to assess the knowledge risk factors and association and the secondary outcome is knowledge and cardiovascular disease risk factors the study will be conducted with general population in bommarabettu village the total sample size is 422 the duration of the study will be for 1 year the standerdized tool has been used |