Value Analysis in Patients Undergoing Self-Management Tra... | NCT06423521

NCT06423521

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Sponsor/Collaborators Module

Name	Class
NOVA Medical School	OTHER
Roche Diagnostics GmbH	INDUSTRY

Oversight Module

Description Module

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:

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.

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Number of events of hypocoagulation symptoms	Zero is equivalent to no hypoagulation symptoms and more than one indicates a symptom	From enrollment to the end of treatment at 12 months
Patient Experience and Satisfaction

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Ana Rita Londral, PhD	Value for Health CoLAB	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Hospital de Santa Marta		Lisbon		1169-024	Portugal

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26112222	Background	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.
31375070	Background

IPD Sharing Statement Module

Intervention Browse Module

ID	Term
D059039	Standard of Care
D000098465	Remote Patient Monitoring

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation

. 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.