Ignite Creation Date:
2025-12-18 @ 9:46 AM
Ignite Modification Date:
2025-12-23 @ 8:46 PM
Study NCT ID:
NCT04205513
Status:
None
Last Update Posted:
2024-03-19 00:00:00
First Post:
2018-11-21 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Telemonitoring to Facilitate Heart Failure Medication Titration
Sponsor:
None
Organization:
Study Overview
Official Title:
Randomized Controlled Trial of a Mobile Phone-based Telemonitoring Application Utilized for the Facilitation of Medication Titration for Patients With Heart Failure
Status:
None
Status Verified Date:
2024-03
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:
Medly Titrate
Brief Summary:
BACKGROUND Heart failure (HF) is a common diagnosis affecting at least 26 million people worldwide. Based on available data from the US and Europe, the overall prevalence of HF ranges from 1% to 12%. The lifetime risks of developing HF, assessed and reported based on a large, diverse, multi-cohort group of 39,578 participants, was shown to be about 30% to 42% in white men, 20% to 29% in black men, 32% to 39% in white women, and 24% to 46% in black women. Survival rates reported in studies also varied, with data from the US and Europe indicating a 1-year survival rate of 89% to 70%, and 5-year survival rates ranging from 59% to as low as 35%, reflecting a significant increase in the risk of death compared to the general age and gender matched population.
The discrepancies in the estimates can most likely be attributed to differences in patient selection, as well as ascertainment and adjustment approaches, however, irrespective of the precise rates, several trends are congruent across studies, including high prevalence, reduced life expectancy, worsening profile with aging and, at best, stagnant incidence rates over the last several decades. These trends have tremendous implications since HF patients are major consumers of healthcare resources.
Large-scale randomized controlled trials have demonstrated that angiotensin receptor-neprilysin inhibitors, angiotensin-converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), beta-blockers and mineralocorticoid receptor antagonists all improve clinical outcomes in HF patients, suggesting that their combination could translate to a 60-70% relative risk reduction in all-cause mortality, and clinical guidelines recommend up titrating the treatments to maximal tolerated doses. However, in clinical practice, evidence from 12,440 HF patients of the European Society of Cardiology Heart Failure Long-Term Registry, showed that about 30% of patients were on target doses of ACEIs, 18% were on target doses of beta-blockers, and approximately one-third had no documented reason for the failure to up-titrate. Barriers to medication titration include health-provider knowledge, self-efficacy and attitudes, patient-related factors and limited time and support facilities to enable regular monitoring.
Remote patient monitoring is a potential component in the management of HF that can provide reliable and real-time physiological data for clinical decision support, alerting, and patient self-management. Telemonitoring enables patients to track their vital signs and symptoms, and also to receive automated instruction and clinical intervention during "teachable moments" (i.e., clear actions are provided when the context is most appropriate). The automated instructions are based on current physiological measurements, self-monitored symptoms, and can be readily analyzed. Automated real-time alerts and frequently collected and analyzed physiological/symptom data can also support clinical decisions by healthcare providers. Several previous studies, including 2 studies conducted by the same research team, have shown that the use of telemonitoring interventions for the management of chronic conditions can lead to positive health outcomes and significant reductions in healthcare costs if the intervention is designed and implemented appropriately. Telemonitoring for HF patients has been shown to be particularly beneficial, demonstrating reduced mortality (risk ratio=0.64; 95% confidence interval: 0.48-0.85), reduction in the use of health services, and similar or improved quality of life and satisfaction compared with standard care.
In response to this evidence, Medly, a telemonitoring program for patients with Heart Failure (HF) has been launched at the University Health Network (UHN). This program is integrated into the Ted Rogers Centre of Excellence in Heart Function at the Peter Munk Cardiac Centre (PMCC) as part of the standard of care.
OBJECTIVES The primary objective of this study is to evaluate the effectiveness and safety of the implementation of telemonitoring to facilitate HF medication titration and its impact on.
The telemonitoring titration management strategy will be compared to the standard titration management program consisting of regular in-office visits.
The hypothesis underlying the primary objective of the study is that both management strategies will enable a comparable proportion of patients to reach optimal doses of HF medications, within similar timeframes, but that telemonitoring will significantly reduce the cost of healthcare resource utilization and patient burden.
The secondary objective of this study is to obtain a deeper understanding of the experience of clinicians and HF patients taking part in the remote titration program, in order to develop better awareness of the factors that can positively impact the implementation and effectiveness of the intervention.
The mobile phone-based telemonitoring system (Medly) enables patients with HF to take clinically relevant physiological measurements with wireless home medical devices in addition to answering symptom questions on the mobile phone. The measurements are automatically and wirelessly transmitted to the mobile phone and then to a data server. Specifically, patients monitor daily weight, blood pressure/heart rate, symptoms, and some patients monitor their activity as determined by their cardiologist. Automated self-care instructions/messages that have been carefully developed with healthcare specialists are sent to the patient based on the readings and reported symptoms. If there are signs of their status deteriorating, an alert is sent to a clinician at the Heart Function Clinic. Through a secure web portal, clinicians receive all relevant patient data, thereby granting them access to current trends and historic data reported by their patients. Clinicians will use information provided by Medly to facilitate remote titration of HF medication doses. A predefined titration management strategy will be established during the initial clinic visit, in accordance with HF management guidelines. Subsequently, telephone contacts will take place at 2-week intervals to titrate medication doses, based on patient-reported data.
PATIENT DATA ACQUISITION Patients will be followed for the duration of their time in the Medly Titrate Program. Data acquisition will include telemonitoring data, patient lab test and examination results, application usage data, data regarding healthcare utilization.
All patients randomized into the study group will also be invited to participate in individual interviews intended to assess their experiences and perceptions regarding the Program upon titration completion.
PROVIDER AND PROGRAM STAFF DATA ACQUISITION Healthcare providers and program staff will be asked to participate in interviews to determine their perceptions of the Medly Titrate Program and of its implementation within existing clinic services.
DATA ANALYSIS Descriptive statistics will be run regularly on all patient outcome measures to monitor the program for quality improvement purposes. Parametric and non-parametric tests will be performed to compare data at baseline and titration completion.
Statistical analyses will be performed using the statistical software application SPSS. Interview data will be analyzed using a conventional content analysis approach. Two evaluators will analyze the transcripts independently and discuss their findings until a consensus is reached. The software program NVivo will be used to help organize the transcript data for analysis.
The underlying assumption is that both remote titration and standard in-office visits will yield similar clinical outcomes, but that the remote management strategy will significantly reduce healthcare resource utilization. Therefore, non-inferiority and superiority analyses will be performed. The intention-to-treat-population, which will include all randomized patients, shall be the study population used for the non-inferiority analysis. The per-protocol-population, which will include all patients who have been treated according to protocol, excluding those who: (a) demonstrated inadequate compliance, or (b) withdrew randomized therapy prematurely without cause, shall be the study population used for the superiority analysis.
DISSEMINATION STRATEGY Results will be shared with Medly Program and HF Clinic decision-makers as they become available, as they will be used for quality improvement purposes. In addition, as these results will be of interest to other clinical settings intending to implement similar telemonitoring programs, the investigators plan to disseminate findings through publications in appropriate scientific journals and through presentations at scientific conferences, as well as other relevant media avenues (e.g., news reports).
The discrepancies in the estimates can most likely be attributed to differences in patient selection, as well as ascertainment and adjustment approaches, however, irrespective of the precise rates, several trends are congruent across studies, including high prevalence, reduced life expectancy, worsening profile with aging and, at best, stagnant incidence rates over the last several decades. These trends have tremendous implications since HF patients are major consumers of healthcare resources.
Large-scale randomized controlled trials have demonstrated that angiotensin receptor-neprilysin inhibitors, angiotensin-converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), beta-blockers and mineralocorticoid receptor antagonists all improve clinical outcomes in HF patients, suggesting that their combination could translate to a 60-70% relative risk reduction in all-cause mortality, and clinical guidelines recommend up titrating the treatments to maximal tolerated doses. However, in clinical practice, evidence from 12,440 HF patients of the European Society of Cardiology Heart Failure Long-Term Registry, showed that about 30% of patients were on target doses of ACEIs, 18% were on target doses of beta-blockers, and approximately one-third had no documented reason for the failure to up-titrate. Barriers to medication titration include health-provider knowledge, self-efficacy and attitudes, patient-related factors and limited time and support facilities to enable regular monitoring.
Remote patient monitoring is a potential component in the management of HF that can provide reliable and real-time physiological data for clinical decision support, alerting, and patient self-management. Telemonitoring enables patients to track their vital signs and symptoms, and also to receive automated instruction and clinical intervention during "teachable moments" (i.e., clear actions are provided when the context is most appropriate). The automated instructions are based on current physiological measurements, self-monitored symptoms, and can be readily analyzed. Automated real-time alerts and frequently collected and analyzed physiological/symptom data can also support clinical decisions by healthcare providers. Several previous studies, including 2 studies conducted by the same research team, have shown that the use of telemonitoring interventions for the management of chronic conditions can lead to positive health outcomes and significant reductions in healthcare costs if the intervention is designed and implemented appropriately. Telemonitoring for HF patients has been shown to be particularly beneficial, demonstrating reduced mortality (risk ratio=0.64; 95% confidence interval: 0.48-0.85), reduction in the use of health services, and similar or improved quality of life and satisfaction compared with standard care.
In response to this evidence, Medly, a telemonitoring program for patients with Heart Failure (HF) has been launched at the University Health Network (UHN). This program is integrated into the Ted Rogers Centre of Excellence in Heart Function at the Peter Munk Cardiac Centre (PMCC) as part of the standard of care.
OBJECTIVES The primary objective of this study is to evaluate the effectiveness and safety of the implementation of telemonitoring to facilitate HF medication titration and its impact on.
The telemonitoring titration management strategy will be compared to the standard titration management program consisting of regular in-office visits.
The hypothesis underlying the primary objective of the study is that both management strategies will enable a comparable proportion of patients to reach optimal doses of HF medications, within similar timeframes, but that telemonitoring will significantly reduce the cost of healthcare resource utilization and patient burden.
The secondary objective of this study is to obtain a deeper understanding of the experience of clinicians and HF patients taking part in the remote titration program, in order to develop better awareness of the factors that can positively impact the implementation and effectiveness of the intervention.
The mobile phone-based telemonitoring system (Medly) enables patients with HF to take clinically relevant physiological measurements with wireless home medical devices in addition to answering symptom questions on the mobile phone. The measurements are automatically and wirelessly transmitted to the mobile phone and then to a data server. Specifically, patients monitor daily weight, blood pressure/heart rate, symptoms, and some patients monitor their activity as determined by their cardiologist. Automated self-care instructions/messages that have been carefully developed with healthcare specialists are sent to the patient based on the readings and reported symptoms. If there are signs of their status deteriorating, an alert is sent to a clinician at the Heart Function Clinic. Through a secure web portal, clinicians receive all relevant patient data, thereby granting them access to current trends and historic data reported by their patients. Clinicians will use information provided by Medly to facilitate remote titration of HF medication doses. A predefined titration management strategy will be established during the initial clinic visit, in accordance with HF management guidelines. Subsequently, telephone contacts will take place at 2-week intervals to titrate medication doses, based on patient-reported data.
PATIENT DATA ACQUISITION Patients will be followed for the duration of their time in the Medly Titrate Program. Data acquisition will include telemonitoring data, patient lab test and examination results, application usage data, data regarding healthcare utilization.
All patients randomized into the study group will also be invited to participate in individual interviews intended to assess their experiences and perceptions regarding the Program upon titration completion.
PROVIDER AND PROGRAM STAFF DATA ACQUISITION Healthcare providers and program staff will be asked to participate in interviews to determine their perceptions of the Medly Titrate Program and of its implementation within existing clinic services.
DATA ANALYSIS Descriptive statistics will be run regularly on all patient outcome measures to monitor the program for quality improvement purposes. Parametric and non-parametric tests will be performed to compare data at baseline and titration completion.
Statistical analyses will be performed using the statistical software application SPSS. Interview data will be analyzed using a conventional content analysis approach. Two evaluators will analyze the transcripts independently and discuss their findings until a consensus is reached. The software program NVivo will be used to help organize the transcript data for analysis.
The underlying assumption is that both remote titration and standard in-office visits will yield similar clinical outcomes, but that the remote management strategy will significantly reduce healthcare resource utilization. Therefore, non-inferiority and superiority analyses will be performed. The intention-to-treat-population, which will include all randomized patients, shall be the study population used for the non-inferiority analysis. The per-protocol-population, which will include all patients who have been treated according to protocol, excluding those who: (a) demonstrated inadequate compliance, or (b) withdrew randomized therapy prematurely without cause, shall be the study population used for the superiority analysis.
DISSEMINATION STRATEGY Results will be shared with Medly Program and HF Clinic decision-makers as they become available, as they will be used for quality improvement purposes. In addition, as these results will be of interest to other clinical settings intending to implement similar telemonitoring programs, the investigators plan to disseminate findings through publications in appropriate scientific journals and through presentations at scientific conferences, as well as other relevant media avenues (e.g., news reports).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: