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A study to assess the impact of mobile application based follow-up of monthly PT-INR of heart valve replacement patients.

Effectiveness of remote mobile App based monitoring of Prothrombin time and INR for follow-up of heart valve replacement patients- A non-randomized trial - MApp-INR

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/09/045991
Enrollment
572
Registered
2022-09-28
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Z09- Encounter for follow-up examination after completed treatment for conditions other than malignant neoplasm Health Condition 2: Z790- Long term (current) use of anticoagulants and antithrombotics/antiplatelets Health Condition 3: I30-I52- Other forms of heart disease

Interventions

Intervention1: Remote follow-up through Mobile application: Patients who are on follow-up with JIPMER Valve clinic and who wish to follow-up remotely will be allocated to Mobile App Arm, for monthly f

Sponsors

Jawaharlal Institute of Postgraduate Medical Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Consecutive consenting patients aged > 18 years who underwent either single (Mitral or Aortic) or double mechanical valve (mitral and aortic) replacement surgery for valvular heart disease. Patient or the attender has a smart phone and is willing to undergo a training session to understand and learn using the app.

Exclusion criteria

Exclusion criteria: Patients in the immediate postoperative follow up period (less than three months) Patients for whom stable INR is not reached Patient who underwent associated procedures like CABG along with valve replacement Patient has associated liver and renal disease Patients with severe heart failure (NYHA IV) Patients with severe postoperative paravalvar leaks/valvar gradients

Design outcomes

Primary

MeasureTime frame
The time in therapeutic range of INR in mobile application will be non-inferior to Time in therapeutic range of patients undergoing Major and minor bleeding complications and tromboembolic episodes in mobile application will be non-inferior to physical follow-up arm.Timepoint: Every 6 months—

Secondary

MeasureTime frame
To compare the direct and indirect costs incurredTimepoint: Every 6 months;To compare the patient satisfaction towards the anti-coagulant therapy using a validated treatment satisfaction questionnaireTimepoint: Every 6 months—

Countries

India

Contacts

Public ContactDr Hemachandren M

Jawaharlal Institute of Post Graduate Medical Education and Research

mhchandren@gmail.com9843220545

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026