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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
 

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