Heart Failure Clinical Trial
— HEARTFELTOfficial title:
A Pragmatic, Single-blind, Randomized Crossover Trial Testing the Effectiveness of Autonomous Remote Patient Peripheral Edema Monitoring and Alerting in HEART FailurE Compared to conventionaL remoTe Patient Monitoring.
This study looks at the effect(s) of using a remote patient monitoring device (Heartfelt device) with health alerts to monitor the formation of peripheral edema in patients with heart failure (HF). The hypothesis is that this passive measurement method will lead to better data availability, which in turn will improve patient care and reduce unscheduled hospitalizations for the management of worsening HF (HFHs). Patients will be recruited through Remote Patient Monitoring Companies (RPMC) based in the US, using crossover stratified randomization between standard care, Heartfelt device usage with health alerts sent to RPMC and Heartfelt device usage with alerts sent to RPMC as well as on-device alerts in the patient's home.
Status | Not yet recruiting |
Enrollment | 1500 |
Est. completion date | September 30, 2029 |
Est. primary completion date | August 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Provision of signed and dated informed consent form (e-consent via website or app is acceptable) - Male or female, aged 18 to [No maximum age]… - Diagnosed with Chronic Heart failure - Exhibited peripheral edema on at least one HF-related hospitalization in the last 4 years (as documented in EPR). - Has been hospitalized for HF at least once in the last 12 months. - Patients who are treated with daily diuretics. - For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 6 weeks after the end of the study. - Has failed to collect at least 50% of days over the last 180 of physiological data from monitoring devices (80% to 85% of all patients participating), OR has been discontinued from remote patient monitoring due to non-adherence (included in the 80-85%), OR, is considered by clinical team as non-adherent but does not have historical physiological data from monitoring devices (15% to 20% of all patients participating). - Is enrolled in a Medicare programme. The RPM company will endeavor to include representative ethnic groups in the recruitment and a minimum of 40% of either biological sex, as well as a mix of ethnicity representative of the local HF patient population. Exclusion Criteria: - Participant has bandages to lower limbs every day - Participant has an amputation of both feet - Participant is a regular wheelchair user inside their home - Participant is bed-bound - Participant is of no fixed abode - Participant is taking part in a conflicting evaluation/study that could confound the results of this evaluation and/or impact clinical interventions and participant outcomes - Participant must not be pregnant and is taking relevant birth control if of child-bearing potential†- Participant who was unable to have the device installed and activated within 90 days of the randomized installation date. - Participant is unable to take diuretics |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Heartfelt Technologies |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | All-Cause Mortality Rate. | This measure tracks the total number of participant deaths due to any cause during the study period. It is an essential indicator of overall participant survival and general safety of the treatment under investigation. This data is collected and verified through clinical records. Measure: The number of all-cause deaths documented in clinical records. Unit of Measure: Count of deaths. |
12 months | |
Primary | Heart Failure Hospitalization Incidence. | This metric quantifies the number of times participants are admitted to the hospital due to heart failure. The criteria for what constitutes a heart failure hospitalization are based on the definition provided by Hicks KA in 2017, ensuring standardized and specific event classification. Measure: The frequency of hospital admissions specifically for heart failure, as defined by Hicks KA, 2017. Unit of Measure: Count of heart failure hospitalization events. |
12 months | |
Primary | Device-Related Complication Rate. | This measure captures the frequency of complications associated with the medical device used in the study. It includes any adverse events or malfunctions linked to the device, providing insight into its safety and performance. Measure: The incidence of complications related to the medical device in use, as specified in Section 12.3.3.2 of the study protocol. Unit of Measure: Count of complication events. |
12 months | |
Secondary | Comparison of Data Availability (number of days with data in a month): Heartfelt Device vs. Existing Remote Monitoring Devices | This measures the variance in data availability, encompassing both device-generated and contemporaneous self-reported data. Measure: Degree of Variance Unit of Measure: Number of days per month with physiological measurements taken. |
12 months | |
Secondary | Hospital Admission Duration | Description: This measures the length of hospital stays, noting the admission and discharge dates. Measure: Length of Stay Unit of Measure: Days |
12 months | |
Secondary | Cause of Hospitalization | This identifies the primary reason for hospitalization. Measure: Cause Hospitalization Category Unit of Measure: Categorical. | 12 months | |
Secondary | Date of Changes in HF Medication Post-Discharge | This tracks the date of any change in heart failure medications after the patient returns home, excluding changes made during ward stays. Measure: Medication Adjustment Date Unit of Measure: Date (YYYY-MM-DD) |
12 months | |
Secondary | Changes in dosage of HF Medication Post-Discharge | This tracks the change(s) in dosage in heart failure medications after the patient returns home, excluding changes made during ward stays. Measure: Medication Adjustment Dosage Unit of Measure: % change from previous dosage. |
12 months | |
Secondary | Cause of Death | This records the cause of death classified as related to heart failure (HF) or not, as defined in Hicks KA, 2017. Measure: Cause of Death Unit of Measure: Categorical |
12 months | |
Secondary | Loss of Independence | This assesses instances where a patient becomes unable to live at home, necessitating care in a facility. Measure: Change in Living Arrangements Unit of Measure: Binary (Independent, Dependent) |
12 months | |
Secondary | Hospitalization Admission Route | This identifies the route of admission during hospitalization events, such as ICU, CCU, or ward admission. Measure: Admission Route Unit of Measure: Categorical (ICU, CCU, Ward) |
12 months | |
Secondary | Scheduling of Care Events | This differentiates between scheduled and unscheduled care events. Measure: Nature of Scheduling Unit of Measure: Categorical (Scheduled, Unscheduled) |
12 months | |
Secondary | Setting of Care Events | This categorizes care events as either inpatient or outpatient. Measure: Care Setting Unit of Measure: Categorical (Inpatient, Outpatient) |
12 months | |
Secondary | Study Withdrawal Details | This records the dates and reasons for participants' withdrawal from the study. Measure: Reason for Withdrawal Unit of Measure: Categorical (Various reasons) |
12 months | |
Secondary | Timestamp of Health Alerts Generated by the Heartfelt Device | This measures the date and time of health alerts generated by the Heartfelt device. Measure: Timestamp of Health Alerts Unit of Measure: Date and time |
12 months | |
Secondary | Frequency of Health Alerts Generated by the Heartfelt Device | This measures the number of health alerts generated by the Heartfelt device over a specified period. Measure: Number of Health Alerts Unit of Measure: Count |
12 months | |
Secondary | Method of Health Alerts Generated by the Heartfelt Device | This assesses the primary methods used to communicate the health alerts generated by the Heartfelt device, categorizing the types of communication employed to notify users. Measure: Type of Communication Method for Health Alerts Unit of Measure: Categorical (e.g., phone call, SMS, email, app notification) |
12 months | |
Secondary | Timestamp of first contact following Health Alerts Generated by the Heartfelt Device | Description: This measures the date and time of the first contact following health alerts generated by the Heartfelt device. Measure: Timestamp of first contact in the 2 weeks following a Health Alerts Unit of Measure: Date and time |
12 months | |
Secondary | Method of Contact Following Health Alerts | This measures the type of contact method initiated in response to health alerts from the Heartfelt device, detailing the types of follow-up communications. Measure: Type of Communication Method for Contact Unit of Measure: Categorical (e.g., phone call, SMS, email, in-person visit) |
12 months |
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