NCT06423521

Brief Summary

Prior research has not assessed the value of remote patient monitoring (RPM) systems for patients undergoing anticoagulation therapy after cardiac surgery. This study aims to assess whether the clinical follow-up through RPM yields comparable outcomes with the standard protocol. A crossover trial assigned participants to SOC-RPM or RPM-SOC, starting with the standard of care (SOC) for the first 6 months after surgery and using RPM for the following 6 months, or vice-versa, respectively. During RPM, patients used the Coaguchek© to accurately measure International Normalized Ratio values and a mobile text-based chatbot to report PROs and adjust the therapeutic dosage. The study assessed patients' and clinicians' experience with RPM and compared direct costs.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 15, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 21, 2024

Completed
Last Updated

June 5, 2024

Status Verified

June 1, 2024

Enrollment Period

2.5 years

First QC Date

May 15, 2024

Last Update Submit

June 4, 2024

Conditions

Post-Cardiac Surgery Patients

Keywords

Digital healthcareTelemediceRemote Patient MonitoringAntocoagulation Therapy

Outcome Measures

Primary Outcomes (1)

  • Time in Therapeutic Range (TTR) for International Normalized Ratio (INR)

    The primary endpoint was the patient's TTR for INR values among the programs, i.e., a comparison between SOC and RPM over time. The TTR for INR value was self-measured by the portable monitor and calculated by the Rosendaal method of lineal interpolation

    From enrollment to the end of treatment at 12 months

Secondary Outcomes (3)

  • Number of events of hypocoagulation symptoms

    From enrollment to the end of treatment at 12 months

  • Patient Experience and Satisfaction

    From enrollment to the end of treatment at 12 months

  • Costs

    From enrollment to the end of treatment at 12 months

Study Arms (2)

SOC-RPM

EXPERIMENTAL

SOC-RPM arm, would follow the Standard of Care (SOC) for the first six months and then receive the Remote Patient Monitoring (RPM).

Other: Standard of Care (SOC)

RPM-SOC

EXPERIMENTAL

RPM-SOC arm: would receive the intervention (RPM) for the first six months and then follow the SOC for the remaining six months.

Other: Remote Patient Monitoring (RPM)

Interventions

Standard of Care (SOC)OTHER

The SOC intervention constitutes the common clinical practice of care that is habitually performed after cardiac surgery to manage anticoagulation therapies.

SOC-RPM
Remote Patient Monitoring (RPM)OTHER

The RPM intervention involves the use of a remote patient monitoring (RPM) system with a portable coagulometer for the clinical follow-up and self-management of International Normalized Ratio (INR) control in patients undergoing anticoagulant therapy post-cardiac surgery. Patients were provided with a Coagulometer-CoaguChek® (Roche Diagnostics, Switzerland) kit and test strips, along with written instructions for conducting measurements. They were also enrolled in a monitoring platform. Patients received regular text messages on their smartphones to report their INR values and symptoms related to anticoagulant therapy. The clinical team received notifications if patients\' reports fell outside therapeutic standards and then responded with medication adjustments via text message.

RPM-SOC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • equal or more than 18 years old and with a smartphone

You may not qualify if:

  • analphabetism, poor health, low digital literacy level and inability to use the RPM alone or with caregiver support

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Santa Marta

Lisbon, 1169-024, Portugal

Location

Related Publications (6)

  • Sharma P, Scotland G, Cruickshank M, Tassie E, Fraser C, Burton C, Croal B, Ramsay CR, Brazzelli M. Is self-monitoring an effective option for people receiving long-term vitamin K antagonist therapy? A systematic review and economic evaluation. BMJ Open. 2015 Jun 25;5(6):e007758. doi: 10.1136/bmjopen-2015-007758.

    PMID: 26112222BACKGROUND

  • Menendez-Jandula B, Garcia-Erce JA, Zazo C, Larrad-Mur L. Long-term effectiveness and safety of self-management of oral anticoagulants in real-world settings. BMC Cardiovasc Disord. 2019 Aug 2;19(1):186. doi: 10.1186/s12872-019-1168-2.

    PMID: 31375070BACKGROUND

  • Azevedo S, Guede-Fernandez F, von Hafe F, Dias P, Lopes I, Cardoso N, Coelho P, Santos J, Fragata J, Vital C, Semedo H, Gualdino A, Londral A. Scaling-up digital follow-up care services: collaborative development and implementation of Remote Patient Monitoring pilot initiatives to increase access to follow-up care. Front Digit Health. 2022 Dec 7;4:1006447. doi: 10.3389/fdgth.2022.1006447. eCollection 2022.

    PMID: 36569802BACKGROUND

  • Wu Y, Wang X, Zhou M, Huang Z, Liu L, Cong L. Application of eHealth Tools in Anticoagulation Management After Cardiac Valve Replacement: Scoping Review Coupled With Bibliometric Analysis. JMIR Mhealth Uhealth. 2024 Jan 5;12:e48716. doi: 10.2196/48716.

    PMID: 38180783BACKGROUND

  • Huang Y, Xie Y, Huang L, Han Z. The Value of Anticoagulation Management Combining Telemedicine and Self-Testing in Cardiovascular Diseases: A Meta-Analysis of Randomized Controlled Trials. Ther Clin Risk Manag. 2023 Mar 14;19:279-290. doi: 10.2147/TCRM.S395578. eCollection 2023.

    PMID: 36941980BACKGROUND

  • Guede-Fernandez F, Silva Pinto T, Semedo H, Vital C, Coelho P, Oliosi ME, Azevedo S, Dias P, Londral A. Enhancing postoperative anticoagulation therapy with remote patient monitoring: A pilot crossover trial study to evaluate portable coagulometers and chatbots in cardiac surgery follow-up. Digit Health. 2024 Aug 6;10:20552076241269515. doi: 10.1177/20552076241269515. eCollection 2024 Jan-Dec.

    PMID: 39139188DERIVED

MeSH Terms

Interventions

Standard of CareRemote Patient Monitoring

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationTelemedicineDelivery of Health CarePatient Care Management

Study Officials

  • Ana Rita Londral, PhD

    Value for Health CoLAB

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

May 15, 2024

First Posted

May 21, 2024

Study Start

October 10, 2021

Primary Completion

April 1, 2024

Study Completion

April 1, 2024

Last Updated

June 5, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)