Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06423521
Status:
COMPLETED
Last Update Posted:
2024-06-05
First Post:
2024-05-15
Brief Title:
Value Analysis in Patients Undergoing Self-Management Training Using a Coagulometer
Sponsor:
Ana Rita Londral PhD
Organization:
Value for Health CoLAB
Study Overview
Official Title:
Value Analysis in Patients Undergoing Anticoagulant Therapy Impact of Self-management Training Using a Coagulometer
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VAPUST
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None