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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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AMAZEâ„¢ is a disease management platform (DMP) designed to educate patients about heart failure, help engage them in healthy behaviors and assist them in taking their medications as prescribed. This study will assess whether the AMAZEâ„¢ smartphone-based application ("app") can help heart failure patients take better care of themselves after discharge from an inpatient heart failure admission at Massachusetts General Hospital (MGH).
The primary objective is to demonstrate feasibility and perceived value of the AMAZEâ„¢ platform in clinical practice. The study will also explore whether the use of the AMAZEâ„¢ platform for 60 days post-discharge leads to a reduction in hospital readmission, emergency department, urgent care and unexpected ambulatory care visits. The impact of the AMAZEâ„¢ platform on participant reported quality of life outcomes and perception of overall medical care will also be examined.
Heart failure (HF) management and readmissions remain at the top of the list of complex topics in cardiovascular medicine in the United States. Current system-wide programs to curb HF-related hospital readmissions have shown inconsistent results. However, outpatient transitional care supportive programs have been linked to improved HF-related outcomes, including reduced hospital readmissions, in small studies. Small studies also indicate that remote transfer of non-invasive data through telemonitoring (e.g., blood pressure and weight) and structured telephone support may reduce hospital readmissions in a cost-effective manner. The present pandemic has placed significant strains on the link between clinicians and patients highlighting the need for rapid innovation for virtual care.
This study involves the AMAZEâ„¢ DMP, developed by AstraZeneca, to provide a unified experience for the management of HF patients throughout their patient care journey. The platform will integrate multiple systems, including a smartphone-based application where patients can enter daily mood, symptoms, weight measures, and vital signs such as blood pressure (BP) and medication adherence. This input will feed directly to a clinician facing dashboard embedded within the electronic medical record that will allow the clinical care team to access real-time views of patients' states both in and out of clinic.
Patients will be identified via an automated electronic medical record (EMR)-based, computer-based algorithm and eligibility will be manually verified. Participants will be enrolled in the study following an inpatient HF admission at Massachusetts General Hospital (MGH).
Clinical providers and study staff will be able to view and monitor the subjects' AMAZEâ„¢ smartphone application entries within the electronic medical record via the AMAZEâ„¢ provider dashboard. The AMAZEâ„¢ secure messaging function will be used for study and clinical communications between the patient, study staff and clinical care team to facilitate outpatient HF management. The AMAZEâ„¢ smartphone application (app) will indirectly assess the patient's quality of life (Kansas City Cardiomyopathy Questionnaire - KCCQ), as well as patient satisfaction with the app (mHealth App Usability Questionnaire - MAUQ). For clinicians, the MAUQ will measure provider satisfaction with the AMAZEâ„¢ dashboard.
Baseline demographics and study outcomes will be assessed via direct patient survey by study staff at pre-specified time points (enrollment, 30-days post enrollment, 60-days post enrollment). Outcomes will include medication changes, hospitalizations, emergency department presentations, urgent care visits, primary care or cardiology office visits and cardiac rehabilitation enrollment. Medical history, including labs, procedures, and diagnoses will be collected from the electronic medical record and recorded in REDCap. The AMAZEâ„¢ app will track medication adherence, daily symptom(s) log, blood pressure, weight, heart rate and activity when entered by participants into a daily log. Participants will be asked and encouraged to enter information into the smartphone-based app daily by study staff.
The primary goal of the present proposal will be to generate evidence on the feasibility and perceived value of the AMAZEâ„¢ platform implemented in clinical practice. The outcomes will be measured using conversion rate (study enrollment rate among total number of eligible patients) and utilization rate (percentage of days participants engaged with the AMAZEâ„¢ app during the 60-day study period). This study is a first necessary step before testing efficacy in a large multi-center study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group - AMAZEâ„¢ Disease Management Platform | Other | Eligible patients 21+ years with a diagnosis of HF admitted to MGH cardiology services. The intervention group is exposed to the AMAZEâ„¢ app for 60 days. Participants will interact with a nurse for a 7-day discharge follow-up call, a medication reconciliation, assess understanding of heart meds, assess patients' HF symptoms, provide tailored guidance, set goals related to medication adherence, exercise, diet, and other health behaviors. The nurse will coordinate with cardiology teams to streamline med refills, cardiology appointments, and cardiac rehabilitation referrals. The nurse and patient will connect via telephone and in-app messaging, to address patients' concerns and state of health. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMAZE (TM) Disease Management Platform | Other | Providing patients with smartphone app that will integrate with provider facing dashboard within electronic medical record. |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Implementation | Feasibility of implementing the AMAZEâ„¢ platform is assessed in terms of the number of patients who completed the study. | 6 months |
| Perceived Value of Disease Management Platform | Perceived value was measured using the participants' scoring of the platform's features in the mHealth App Usability Questionnaire (MAUQ). The questionnaire has 21 questions, with scores were based on a scale of 1 (disagree) to 7 (agree). | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Management Platform Engagement | Participants' engagement with the platform was measured in terms of daily logs completed and number of messages sent to the nurse navigator. | 60 days |
| Health Status Change With Use of Disease Management Platform |
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Inclusion Criteria:
Adults (>21 years) admitted to MGH Cardiology services (Ellison 10 and 11) with a primary diagnosis of heart failure [HFrEF(<40%), HFmEF(40-49%) HFpEF(≥50%)] (or to BWH Cardiology services for BWH EHR-based controls)
Has a smartphone or iPad and is willing to enter health metrics into DMP App and email willing to use for the study
Access to the internet
Established or with plan to establish primary cardiologist at MGH (or at BWH for BWH EHR-based controls)
Discharged home or to self-care (with or without home services)
Exclusion Criteria:
Moderate or severe cognitive impairment
Non-English-speaking
Palliative management only (comfort measures)
Does not own a smartphone or iPad (not considered for EHR-based controls)
Incarcerated
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| Name | Affiliation | Role |
|---|---|---|
| Pradeep Natarajan, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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Over the 6-months 2,071 patients were screened. Of these, 409 were considered eligible for the study. Staff approached 167 patients. A total of 70 patients consented to participate. A total of 51 out of 70 enrolled patients completed the study. Common reasons patients declined were study felt like it might be too much work (n=51), did not feel comfortable using smartphone (n=17), requested time to consider, but could not be contacted (n=10). Declined to provide a reason (n=10)
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group - AMAZEâ„¢ Disease Management Platform | The intervention group was exposed to the AMAZEâ„¢ app for 60 days, following discharge from the hospital. Patients were consented once eligibility was confirmed. During the 60-day period, patients were expected to complete daily logs of wellbeing, heart failure symptoms, physical activity levels, medication adherence, weight, blood pressure, and heart rate. Patients were prompted to complete the KCCQ and MAUQ within the app at set timepoints. AMAZEâ„¢ contained curated links to articles about heart failure causes, diagnosis, and management which patients could access at will. Patients received a 7-day discharge follow-up call from the nurse navigator. The nurse completed a medication reconciliation and assessed and expanded the patients' understanding of their heart medications. The nurse asked questions about the patients' heart failure symptoms and provided guidance for symptom monitoring and management, discussed lifestyle modifications and assisted in setting goals related to medication adherence, exercise, diet, and other health behaviors. The nurse coordinated with the patients' clinical care team, streamlining med refills, cardiology appointments, and cardiac rehab referrals. Subsequent correspondences between the nurse and patient took place by telephone and in-app messaging for the duration of the study period. The nurse navigator addressed patients' concerns, questions, and state of health as represented by data entered by the patients into the app. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group - AMAZEâ„¢ Disease Management Platform | The intervention group was exposed to the AMAZEâ„¢ app for 60 days, following discharge from the hospital. Patients were consented once eligibility was confirmed. During the 60-day period, patients were expected to complete daily logs of wellbeing, heart failure symptoms, physical activity levels, medication adherence, weight, blood pressure, and heart rate. Patients were prompted to complete the KCCQ and MAUQ within the app at set timepoints. AMAZEâ„¢ contained curated links to articles about heart failure causes, diagnosis, and management which patients could access at will. Patients received a 7-day discharge follow-up call from the nurse navigator. The nurse completed a medication reconciliation and assessed and expanded the patients' understanding of their heart medications. The nurse asked questions about the patients' heart failure symptoms and provided guidance for symptom monitoring and management, discussed lifestyle modifications and assisted in setting goals related to medication adherence, exercise, diet, and other health behaviors. The nurse coordinated with the patients' clinical care team, streamlining med refills, cardiology appointments, and cardiac rehab referrals. Subsequent correspondences between the nurse and patient took place by telephone and in-app messaging for the duration of the study period. The nurse navigator addressed patients' concerns, questions, and state of health as represented by data entered by the patients into the app. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of Implementation | Feasibility of implementing the AMAZEâ„¢ platform is assessed in terms of the number of patients who completed the study. | English-speaking patients aged 21 years and older who carried a chart diagnosis of heart failure with established or planned longitudinal cardiovascular care at MGH | Posted | Count of Participants | Participants | 6 months |
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Participants were monitored for adverse events over the 60-day study period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group - AMAZEâ„¢ Disease Management Platform | Over the six-month recruitment period (03/2021-09/2021) there are no adverse events to report for the 70 participants enrolled. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kaavya Paruchuri, MD | Massachusetts General Hospital | 617-726-1843 | kparuchuri@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 17, 2021 | Mar 13, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 15, 2021 | Mar 13, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C035019 | isofenphos |
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Health status was ascertained based on participants' responses to the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ), which assesses heart failure symptoms and impact on quality of life. The questionnaire was administered at baseline, 30 days after enrolling in the study, and 60 days after enrolling in the study. Change in health status was measured by the difference in scores between the first and last KCCQ completed (baseline and 60 days after). KCCQ scores range from 0 (very poor health) to 100 (excellent health). An increase in score indicates improvement in health status and a decrease indicates worsening health status. The measure we use here reports the change in KCCQ scores from a 15-point decrease to a 15-point increase from baseline in increments of 5 points. |
| 60 days |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Clinical conditions and co-morbidities | Number | participants |
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| OG002 | Enrolled Patients | Patients who consented to participating in the study |
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| Primary | Perceived Value of Disease Management Platform | Perceived value was measured using the participants' scoring of the platform's features in the mHealth App Usability Questionnaire (MAUQ). The questionnaire has 21 questions, with scores were based on a scale of 1 (disagree) to 7 (agree). | Of 51 completed participants, 21(41.2%) completed the 60-day MAUQ. | Posted | Median | Inter-Quartile Range | score on a scale | 60 days |
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| Secondary | Disease Management Platform Engagement | Participants' engagement with the platform was measured in terms of daily logs completed and number of messages sent to the nurse navigator. | Posted | Median | Inter-Quartile Range | days | 60 days |
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| Secondary | Health Status Change With Use of Disease Management Platform | Health status was ascertained based on participants' responses to the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ), which assesses heart failure symptoms and impact on quality of life. The questionnaire was administered at baseline, 30 days after enrolling in the study, and 60 days after enrolling in the study. Change in health status was measured by the difference in scores between the first and last KCCQ completed (baseline and 60 days after). KCCQ scores range from 0 (very poor health) to 100 (excellent health). An increase in score indicates improvement in health status and a decrease indicates worsening health status. The measure we use here reports the change in KCCQ scores from a 15-point decrease to a 15-point increase from baseline in increments of 5 points. | Of the 51 participants who completed the study, 29 participants completed at least two surveys of the baseline and 30- and 60-day KCCQs. | Posted | Number | participants | 60 days |
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| 70 |
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| 70 |
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| 70 |
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| The information in the app was well organized, so I could easily find the information I needed |
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| I feel comfortable using this app in social settings |
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| The amount of time involved in using this app has been fitting for me |
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| I would use this app again |
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| Overall, I am satisfied with this app |
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| Whenever I made a mistake using the app, I could recover easily and quickly |
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| This mHealth app provides an acceptable way to receive healthcare services |
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| The app adequately acknowledged and provided information to let me know the progress of my action |
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| The navigation was consistent when moving between screens |
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| The interface of the app allowed me to use all the functions offered by the app |
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| This app has all the functions and capabilities I expected it to have |
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| The app would be useful for my health and wellbeing |
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| The app improved my access to healthcare services |
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| The app helped me manage my health effectively |
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| The app made it convenient for me to communicate with my healthcare provider |
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| Using the app, I had many more opportunities to interact with my healthcare provider |
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| I felt confident that any information I sent to my provider using the app would be received |
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| I felt comfortable communicating with my healthcare provider using the app |
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| Number of participants whose score did not change |
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| Number of participants whose score increased by at least 5 points |
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| Number of participants whose score increased by at least 10 points |
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| Number of participants whose score increased by at least 15 points |
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