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

Ana Rita Londral, PhD

Status: Completed

Conditions: Post-Cardiac Surgery Patients

Treatments: Other: Standard of Care (SOC); Other: Remote Patient Monitoring (RPM)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06423521

1057/2021

Details and patient eligibility

About

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.

Full description

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:

1. 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.
2. 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.
3. 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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

28 participants in 2 patient groups

SOC-RPM

Experimental group

Description:

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

Treatment:

Other: Standard of Care (SOC)

RPM-SOC

Experimental group

Description:

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

Treatment:

Other: Remote Patient Monitoring (RPM)