Can SMS reminders help in better adherence to INR monitoring : a randomized controlled trial

Completed

• Conditions: Cerebral infarction due to embolism of cerebral arteries,

• Registration Number: CTRI/2018/10/016165
• Lead Sponsor: All India Institute Of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-25
• Last Update Posted: 2022-06-15

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

• 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.

Exclusion Criteria

• 1.Any contraindication to anticoagulation.
• 2.Unwillingness to participate in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
a.Time in therapeutic range for each patient.	b.Percentage of INR readings in therapeutic range for each patient

Trial Locations

Locations (1)

All India Institute Of Medical Sciences; 🇮🇳 Delhi, DELHI, India

All India Institute Of Medical Sciences

🇮🇳Delhi, DELHI, India

Manish Bhartiya

Principal investigator

7798225630

manishct82@gmail.com