Skip to main content
OpenTrials
Completed

NCT Number: NCT06423521

Value Analysis in Patients Undergoing Self-Management Training Using a Coagulometer

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Post-Cardiac Surgery Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Santa Marta

Lisbon, 1169-024, Portugal

About this study

The main objective of this pilot study was to evaluate the outcomes and costs of a digital clinical service to support patients with anticoagulant therapy after cardiac surgery. This study used an RPM-based system with a portable coagulometer for clinical follow-up and self-management of INR control and compared with the standard of care (SOC). In addition, this study seeks to assess patients' and clinical teams' satisfaction and experience.

Patients were recruited in sequential order based on their availability in the cardiothoracic surgery department. The participants were assigned into two arms: one would follow the SOC for the first six months and then receive the RPM intervention for the following six months (SOC-RPM); the other group would receive the intervention (RPM) for the first six months and then follow the SOC for the remaining six months (RPM-SOC). Blinding was not feasible due to the nature of the trial, and both patients and the clinical team were aware of the follow-up being conducted. In this study, it was decided that a washout period was not required. This was because withdrawing effective follow-up care for a washout period is not possible, as patients need to be constantly monitored to ensure effective treatment, thus preventing thromboembolic events. The study was conducted for twelve months, as follows:

  • Patients received a kit with a Coagulometer-CoaguChek® (Roche Diagnostics, Switzerland) and the necessary test strips for use during the period established, as well as written instructions on how to take the measurements, and were registered on the monitoring platform.
  • Patients received periodic text messages on their smartphones to report the INR value, and they responded to messages regarding their symptoms related to anticoagulant therapy and the INR value.
  • The clinical team received notifications if patients' reports had been assessed outside therapeutic standards and then sent a text message back with the medication adjustment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: From enrollment to the end of treatment at 12 months

    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

Secondary outcomes

  1. Number of events of hypocoagulation symptoms

    Time frame: From enrollment to the end of treatment at 12 months

    Zero is equivalent to no hypoagulation symptoms and more than one indicates a symptom

  2. Patient Experience and Satisfaction

    Time frame: From enrollment to the end of treatment at 12 months

    . A questionnaire with 13 self-reported questions was used to evaluate patient experience and satisfaction. The first four questions measured experience, while the following nine focused on satisfaction. The responses were rated on a scale of disagree to agree, with 1-4 points assigned to each response. To prevent ceiling and floor effects in our tool, the questions numbered '2', '11', and '12' were calculated as "inverted," and an optional open question was included. The questionnaire used to assess experience and satisfaction is not validated, precluding external validity. Still, it was used due to the lack of instruments in Portuguese language to assess the experience and satisfaction of digital health RPM-based systems.

  3. Costs

    Time frame: From enrollment to the end of treatment at 12 months

    The method used in the trial compared the average cost per patient in standard of care (SOC) versus remote patient monitoring (RPM) using the Time-Driven Activity-Based Costing (TDABC) method from the perspective of the Public National Healthcare Service (NHS). The method involved mapping patient pathway activities and identifying direct costs such as healthcare professionals, facilities, equipment and technology, and consumables. Costs for healthcare professionals, equipment and technology, and facilities were determined based on market value, depreciation rate, and public salary scale. Travel costs for patients undergoing SOC were considered, and all monetary values are in Euros as of 2023.

Sponsors and collaborators

Lead sponsor

Ana Rita Londral, PhD

Other

Collaborators

  • NOVA Medical School
  • Roche Diagnostics GmbH

Registry information

Official study title

Value Analysis in Patients Undergoing Anticoagulant Therapy: Impact of Self-management Training Using a Coagulometer

Acronym: VAPUST

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 21, 2024
Registry last updated
Jun 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.