CTRI Number |
CTRI/2018/01/011372 [Registered on: 16/01/2018] Trial Registered Retrospectively |
Last Modified On: |
20/09/2017 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Screening Behavioral |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
Modification(s)
|
Cardiovascular risk assessment and management by nurses in India |
Scientific Title of Study
Modification(s)
|
Risk prediction by nurses to assess and manage cardiovascular risk for primary and secondary prevention of cardiovascular diseases in a tertiary health care setting |
Secondary IDs if Any
|
Secondary ID |
Registry |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
Name |
Kavita |
Address |
National Institute of nursing education, PGIMER Chandigarh
160012
Chandigarh CHANDIGARH 160036 India |
Phone |
9872839990 |
Fax |
|
Email |
gaurikavita@rediffmail.com |
|
Details Contact Person Scientific Query
Modification(s)
|
Name |
Kavita |
Address |
National Institute of Nursing Education, PGIMER Chandigarh
Chandigarh CHANDIGARH 160012 India |
Phone |
9872839990 |
Fax |
|
Email |
gaurikavita@rediffmail.com |
|
Details Contact Person Public Query
Modification(s)
|
Name |
Kavita |
Address |
National Institute of Nursing Education, PGIMER Chandigarh
Chandigarh CHANDIGARH 160012 India |
Phone |
9872839990 |
Fax |
|
Email |
gaurikavita@rediffmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
Kavita, Lecturer, National institute of nursing education,PGIMER, Chandigarh |
|
Primary Sponsor
Modification(s)
|
Name |
Kavita |
Address |
Lecturer NINE, PGIMER Chandigarh |
Type of Sponsor |
Other [self funded no sponsor] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
No of Sites = 1 |
Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr JS Thakur |
Post graduate institute of medical education and research Chandigarh |
Medicine and allied OPDs, Cardiology OPDs
PGIMER Chandigarh Chandigarh |
9463602173
jsthakur64@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institute Ethics Committee PGIMER Chandigarh |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
1. Hypertension
2. Coronary artery disease |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Risk communication on healthy diet, physical activity ,no tobacco ,stress management, medication adherence etc. |
For the intervention risk communication package has been developed by investigator which included a manual for nurses, booklet for patients and flash cards to be used by nurses while giving health education. |
Intervention |
Screening for CVD risk and risk communication
|
the study includes task shifting by training the nurses in CVD risk assessment and communication.
For primary prevention group the patients with hypertension will be screened for CVD risk by using WHO/ISH risk prediction charts followed by risk communication by trained nurses. No control group or randomization will be done for this group because of ethical concerns.
For secondary prevention group patients with Coronary artery disease will be enrolled in intervention and control group using block randomization. Risk communication and emphasis on medication adherence will be done in intervention group by trained nurses whereas control group will include usual care. |
Comparator Agent |
usual care |
for primary prevention no control group but for secondary prevention group control group will receive usual care |
|
Inclusion Criteria
|
Age From |
40.00 Year(s) |
Age To |
98.00 Year(s) |
Gender |
Both |
Details |
For primary prevention adults aged 40 years and above with hypertension and for secondary prevention patients with CAD will be included in the study |
|
ExclusionCriteria |
Details |
For primary prevention patients with CVDs and for secondary prevention patients who are terminally ill will be excluded |
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Open Label |
Primary Outcome
Modification(s)
|
Outcome |
TimePoints |
Risk modification
Medication adherence |
one year |
|
Secondary Outcome
|
Outcome |
TimePoints |
Feasibility of using WHO/ISH risk prediction charts by nurses as a routine practice |
one year |
|
Target Sample Size
|
Total Sample Size="900" Sample Size from India="900" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
16/05/2014 |
Date of First Enrollment (Global) |
No Date Specified |
Estimated Duration of Trial
|
Years="4" Months="2" Days="2" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
None |
Brief Summary
|
The study is a Ph.D thesis work. It is a Quasi experimental study for primary and secondary prevention of Cardiovascular diseases(CVDs). The study involves task shifting by training nurses in CVD risk assessment and management by using WHO/ISH risk prediction charts. Risk communication package has been developed by the investigator to train nurses. For primary prevention of CVDs these train nurses will assess the CVD risk of patients with hypertension from medicine and allied OPDs which will be followed by risk communication. For secondary prevention the patients with coronary artery disease will be recruited from cardiac OPD.Risk Communication for secondary prevention will be done by trained nurses for secondary prevention of CVDs. There will be no risk assessment in the secondary prevention group as these patients at already at high risk. The outcome variable includes risk modification and medication adherence for primary and secondary prevention group respectively |