Clinical trial NCT06423521: Value Analysis in Patients Undergoing Self-Management Training Using a Coagulometer
Official title: Value Analysis in Patients Undergoing Anticoagulant Therapy: Impact of Self-management Training Using a Coagulometer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Cardiac Surgery Patients
Keywords: Digital healthcare
Telemedice
Remote Patient Monitoring
Antocoagulation Therapy
Lead sponsor: Value for Health CoLAB
Sponsor class: OTHER
Collaborators: name: NOVA Medical School
name: Roche Diagnostics GmbH
First posted: 2024-05-21
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time in Therapeutic Range (TTR) for International Normalized Ratio (INR)
timeFrame: From enrollment to the end of treatment at 12 months
Secondary outcomes:
measure: Number of events of hypocoagulation symptoms
timeFrame: From enrollment to the end of treatment at 12 months
measure: Patient Experience and Satisfaction
timeFrame: From enrollment to the end of treatment at 12 months
measure: Costs
timeFrame: From enrollment to the end of treatment at 12 months
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: Hospital de Santa Marta
Study officials:
affiliation: Value for Health CoLAB
name: Ana Rita Londral, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.