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CTRI Number  CTRI/2018/10/016165 [Registered on: 26/10/2018] Trial Registered Retrospectively
Last Modified On: 15/06/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [SMS]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Can SMS reminders help in better adherence to INR monitoring : a randomized controlled trial 
Scientific Title of Study   Efficacy of Short Message Service (SMS) Reminders on Adherence to INR Monitoring in Patients on Anticoagulation with Vitamin K Antagonists(VKA) : A Randomised Controlled Trial 
Trial Acronym  ESRAIK trial 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrKameshwar Prasad 
Designation  Professor 
Affiliation  All India Institute Of Medical Sciences 
Address  Room No 702 Dept Of Neurology AIIMS

New Delhi
DELHI
110029
India 
Phone  7798225630  
Fax    
Email  drkameshwarprasad@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manish Bhartiya 
Designation  Senior Resident 
Affiliation  All India Institute Of Medical Sciences 
Address  Room No 702 Dept Of Neurology AIIMS

South
DELHI
110029
India 
Phone  7798225630  
Fax    
Email  manishct82@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Manish Bhartiya 
Designation  Senior Resident 
Affiliation  All India Institute Of Medical Sciences 
Address  Room No 702 Dept Of Neurology AIIMS

South
DELHI
110029
India 
Phone  7798225630  
Fax    
Email  manishct82@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Ansari Nagar New Delhi India 
 
Primary Sponsor  
Name  All India Institute Of Medical Sciences 
Address  Ansari Nagar New Delhi Pin 110029 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Manish Bhartiya  All India Institute Of Medical Sciences  Room No 702 CN Center
New Delhi
DELHI 
7798225630
7798225630
manishct82@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH ,ALL INDIA INSTITUTE OF MEDICAL SCIENCES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I634||Cerebral infarction due to embolism of cerebral arteries,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Short message service ( SMS) to the interventional group reminding them to get INR test done.  A SMS will be sent to the interventional group on 02 consecutive days reminding them to get the INR test done on the due date 
Comparator Agent  The second group which will be comparator group which will not receive any SMS  The second group will be patients on anticoagulation who will not receive any SMS reminder to get their INR test done. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1 Age more than 18yrs
2 Patients requiring anticoagulation as treatment ,primary prevention or secondary prophylaxis for any medical condition atleast 06 months.
3 Willingness to participate in the study
4 Accessibility to mobile phone.
5 Patients or caregivers who are able to understand SMS on mobile phones
 
 
ExclusionCriteria 
Details  1.Any contraindication to anticoagulation.
2.Unwillingness to participate in the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Proportion of patients adhering to INR monitoring as advised in both the groups at the end of six months  Proportion of patients adhering to INR monitoring as advised in both the groups at the end of six months after the date of enrolment 
 
Secondary Outcome  
Outcome  TimePoints 
a.Time in therapeutic range for each patient.
b.Percentage of INR readings in therapeutic range for each patient
c.Proportion of patients having Time in therapeutic range of INR65 %at the end of study.
d.Thrombotic events at the end of of the study .
e.Major bleeds at the end of o6 months of follow up
 
at 06 months 
 
Target Sample Size   Total Sample Size="98"
Sample Size from India="98" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/01/2018 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Anticoagulants are commonly used in clinical practice for both treatment as well as prevention of various illnesses. . The usual approach is initiation of anticoagulation with unfractionated heparin or low molecular  weight heparin followed by administration of  oral anticoagulants which include vitamin K antagonists(VKA). The therapeutic efficacy of VKAs is monitored by International normalized ration (INR) target range being 2-3 depending on the previous h/o any thrombotic events. Usual practice followed in India is clinic based monitoring of INR. The frequency of monitoring of INR varies from case to case but is usually daily till target INR is achieved followed by once every 02 weeks and if it is in therapeutic range then once every month. Whether the patient has been in effective anticoagulation during this period is assessed by time in therapeutic range (TTR)which is most commonly measured by Rosedaal method. There have been no studies in Indian settings assessing the efficacy of oral anticoagulation in patients on Vitamin K antagonists. There have been no studies in Indian settings assessing the effective anticoagulation.  Both subtherapeutic and supratherpeutic ranges of INR are detrimental to patient outcome ,Subtherapeutic exposing patient to increased risk of thrombotic events and supratherapeutic increasing the risk of major bleeding events. Hence it is of prime importance to maintain the INR in narrow therapeutic range. Also if SMS based reminders can improve adherence to regular INR testing and  the time therapeutic range it will obviate the need of an otherwise clinically stable patient to visit the hospital only for INR monitoring hence saving the time of clinician as well as the patient. 

 
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