Post-Cardiac Surgery PatientsVAPUSTNCT06423521
Value Analysis in Patients Undergoing Self-Management Training Using a Coagulometer
A study testing Remote Patient Monitoring (RPM) in people with Post-Cardiac Surgery Patients, run by Ana Rita Londral, PhD at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Cardiac Surgery Patients
- What is being tested?
- Remote Patient Monitoring (RPM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePortugal
- Study dates
- 10 Oct 2021to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- equal or more than 18 years old and with a smartphone
Who cannot join
- analphabetism, poor health, low digital literacy level and inability to use the RPM alone or with caregiver support
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Value Analysis in Patients Undergoing Anticoagulant Therapy: Impact of 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.
Read the 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.
- Conditions
- Post-Cardiac Surgery Patients
- Being tested
- Standard of Care (SOC), Remote Patient Monitoring (RPM)
- Keywords
- Digital healthcare, Telemedice, Remote Patient Monitoring, Antocoagulation Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: Remote Patient Monitoring (RPM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to the end of treatment at 12 months
Secondary outcomes (3)
Number of events of hypocoagulation symptoms
Zero is equivalent to no hypoagulation symptoms and more than one indicates a symptom
Measured: From enrollment to the end of treatment at 12 months
Patient Experience and Satisfaction
. 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.
Measured: From enrollment to the end of treatment at 12 months
Costs
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.
Measured: From enrollment to the end of treatment at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start10 Oct 2021
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Post-Cardiac Surgery PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ana Rita Londral, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- NOVA Medical School, Roche Diagnostics GmbH
- Responsible party
- Sponsor-investigator, Ana Rita Londral, PhD, Value for Health CoLAB
- Investigators
- Ana Rita Londral, PhD, Principal investigator, Value for Health CoLAB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423521
- Sponsor's protocol ID
- 1057/2021
- Acronym
- VAPUST
- Status last verified
- Jun 2024
- First submitted
- 15 May 2024
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26112222Menendez-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.
PubMed 31375070Azevedo 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.
PubMed 36569802Wu 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.
PubMed 38180783Huang 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.
PubMed 36941980Guede-Fernandez F, Silva Pinto T, Semedo H, Vital C, Coelho P, Oliosi ME, Azevedo S, Dias P, Londral A. Enhancing postoperative anticoagulation therapy with remote patient monitoring: A pilot crossover trial study to evaluate portable coagulometers and chatbots in cardiac surgery follow-up. Digit Health. 2024 Aug 6;10:20552076241269515. doi: 10.1177/20552076241269515. eCollection 2024 Jan-Dec.
PubMed 39139188
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value Analysis in Patients Undergoing Anticoagulant Therapy: Impact of Self-management Training Using a Coagulometer
- ClinicalTrials.gov ID
- NCT06423521
- Acronym / sponsor ID
- VAPUST / 1057/2021
- Conditions
- Post-Cardiac Surgery Patients
- Keywords
- Digital healthcare, Telemedice, Remote Patient Monitoring, Antocoagulation Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Ana Rita Londral, PhDUniversity, hospital or other
- Collaborators
- NOVA Medical School, Roche Diagnostics GmbH
- Study start
- 10 Oct 2021 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 21 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOC-RPM | Experimental | Other: Standard of Care (SOC)SOC-RPM arm, would follow the Standard of Care (SOC) for the first six months and then receive the Remote Patient Monitoring (RPM). |
| RPM-SOC | Experimental | Other: Remote Patient Monitoring (RPM)RPM-SOC arm: would receive the intervention (RPM) for the first six months and then follow the SOC for the remaining six months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- equal or more than 18 years old and with a smartphone
Key exclusion criteria (1 listed)
- analphabetism, poor health, low digital literacy level and inability to use the RPM alone or with caregiver support
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of Care (SOC)The SOC intervention constitutes the common clinical practice of care that is habitually performed after cardiac surgery to manage anticoagulation therapies. | Other | SOC-RPM |
| Remote Patient Monitoring (RPM)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. | Other | RPM-SOC |
Primary outcome
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
3 secondary outcomes
Number of events of hypocoagulation symptoms
Time frame: From enrollment to the end of treatment at 12 months
Patient Experience and Satisfaction
Time frame: From enrollment to the end of treatment at 12 months
Costs
Time frame: From enrollment to the end of treatment at 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Background: PubMed 26112222Sharma 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.
- Background: PubMed 31375070Menendez-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.
- Background: PubMed 36569802Azevedo 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.
- Background: PubMed 38180783Wu 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.
- Background: PubMed 36941980Huang 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.
- Derived from this study: PubMed 39139188Guede-Fernandez F, Silva Pinto T, Semedo H, Vital C, Coelho P, Oliosi ME, Azevedo S, Dias P, Londral A. Enhancing postoperative anticoagulation therapy with remote patient monitoring: A pilot crossover trial study to evaluate portable coagulometers and chatbots in cardiac surgery follow-up. Digit Health. 2024 Aug 6;10:20552076241269515. doi: 10.1177/20552076241269515. eCollection 2024 Jan-Dec.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Rita Londral, PhD principal investigator
Value for Health CoLAB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Patient Monitoring (RPM) in people with Post-Cardiac Surgery Patients, run by Ana Rita Londral, PhD at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in Therapeutic Range (TTR) for International Normalized Ratio (INR) (time frame: From enrollment to the end of treatment at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06423521, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2024.