| CTRI Number |
CTRI/2018/05/013789 [Registered on: 09/05/2018] Trial Registered Prospectively |
| Last Modified On: |
08/05/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
This study is conducted among patient with Cardiovascular diseases and awareness on Cardiovascular diseases, depression,social support, clinical and functional status assessment will be gathered from the patients who are attending the hospital including inpatients from Udupi district. |
|
Scientific Title of Study
|
Risk awareness, psychosocial variables, clinical and functional status among patients with cardiovascular disease in a tertiary care hospital in Udupi district. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sulochana B |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Nursing Manipal |
| Address |
Manipal College of Nursing Manipal
Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9844995784 |
| Fax |
|
| Email |
sulochana.k@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Linu Sara George |
| Designation |
Professor |
| Affiliation |
Manipal College of Nursing Manipal |
| Address |
Manipal College of Nursing Manipal
Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845602400 |
| Fax |
|
| Email |
linu.j@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Sulochana B |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Nursing Manipal |
| Address |
Manipal College of Nursing Manipal
Manipal Academy of Higher Education, Manipal
KARNATAKA
576104
India |
| Phone |
9844995784 |
| Fax |
|
| Email |
sulochana.k@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Nursing |
|
|
Primary Sponsor
|
| Name |
self financing by the investigators |
| Address |
Investigators of the study |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Sulochana B |
Kasturba Hospital Manipal |
Cardiology Department, Kasturba Hospital, Manipal
Udupi
KARNATAKA |
9844995784
sulochana.k@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Kasturba Hospital,Manipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Established cardiovascular disease , |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Day(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Study participants 30-60 years of age
Individuals who are having established cardiovascular disease visiting the outpatient
departments of cardiology |
|
| ExclusionCriteria |
| Details |
People with advanced illness/complications |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Cardiovascular disease risk awareness
Functional status
Depression and social support |
2.6 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Needs for educational interventions for CVD patients |
2 years |
|
|
Target Sample Size
|
Total Sample Size="246"
Sample Size from India="246"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
21/05/2018 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet started the data collection |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study will be conducted in the inpatient and outpatient department of cardiology and department of cardiovascular vascular surgery, Kasturba Hospital Manipal. Data will be collected after obtaining informed consent from the patients. n= =246 An FGD will be carried out to assess the learning needs and barriers regarding health care services A group of 6-10 patient will be considered for FGD Data will be collected using Semi-structured questionnaire |