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
|
|
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
|
|
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. |