Heart Failure
Conditions
Brief summary
AMAZE™ 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 AMAZE™ 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 AMAZE™ platform in clinical practice. The study will also explore whether the use of the AMAZE™ 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 AMAZE™ platform on participant reported quality of life outcomes and perception of overall medical care will also be examined.
Detailed description
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 AMAZE™ 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' AMAZE™ smartphone application entries within the electronic medical record via the AMAZE™ provider dashboard. The AMAZE™ 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 AMAZE™ 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 AMAZE™ 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 AMAZE™ 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 AMAZE™ 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 AMAZE™ app during the 60-day study period). This study is a first necessary step before testing efficacy in a large multi-center study.
Interventions
OTHERAMAZE (TM) Disease Management Platform
Providing patients with smartphone app that will integrate with provider facing dashboard within electronic medical record.
Sponsors
AstraZeneca
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Implementation | 6 months | Feasibility of implementing the AMAZE™ platform is assessed in terms of the number of patients who completed the study. |
| Perceived Value of Disease Management Platform | 60 days | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Management Platform Engagement | 60 days | Participants' engagement with the platform was measured in terms of daily logs completed and number of messages sent to the nurse navigator. |
| Health Status Change With Use of Disease Management Platform | 60 days | 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. |
Countries
United States
Participant flow
Recruitment details
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)
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group - AMAZE™ Disease Management Platform The intervention group was exposed to the AMAZE™ 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.
AMAZE™ 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. | 51 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | No Longer Eligible Post-Consent | 8 |
| Overall Study | Protocol Violation | 6 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Intervention Group - AMAZE™ Disease Management Platform |
|---|---|
| Age, Customized Age Mean | 65.9 years STANDARD_DEVIATION 12.9 |
| Clinical conditions and co-morbidities Abdominal aortic aneurysm | 3 participants |
| Clinical conditions and co-morbidities Anemia | 26 participants |
| Clinical conditions and co-morbidities Atrial fibrillation | 29 participants |
| Clinical conditions and co-morbidities Cancer | 11 participants |
| Clinical conditions and co-morbidities Cerebrovascular disease | 10 participants |
| Clinical conditions and co-morbidities Chronic kidney disease | 19 participants |
| Clinical conditions and co-morbidities Chronic lung disease | 18 participants |
| Clinical conditions and co-morbidities Cirrhosis | 2 participants |
| Clinical conditions and co-morbidities Coronary artery disease | 39 participants |
| Clinical conditions and co-morbidities Depression | 25 participants |
| Clinical conditions and co-morbidities Diabetes | 16 participants |
| Clinical conditions and co-morbidities Familial hypercholesterolemia | 3 participants |
| Clinical conditions and co-morbidities Hyperlipidemia | 36 participants |
| Clinical conditions and co-morbidities Hypertension | 45 participants |
| Clinical conditions and co-morbidities Obstructive sleep apnea | 18 participants |
| Clinical conditions and co-morbidities Peripheral artery disease event | 9 participants |
| Clinical conditions and co-morbidities Thyroid disorder | 10 participants |
| Race/Ethnicity, Customized Asian | 0 Participants |
| Race/Ethnicity, Customized Black | 3 Participants |
| Race/Ethnicity, Customized Other | 2 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants |
| Race/Ethnicity, Customized White | 46 Participants |
| Sex/Gender, Customized Female | 15 Participants |
| Sex/Gender, Customized Male | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 70 |
| other Total, other adverse events | 0 / 70 |
| serious Total, serious adverse events | 0 / 70 |
Outcome results
Primary
Feasibility of Implementation
Feasibility of implementing the AMAZE™ platform is assessed in terms of the number of patients who completed the study.
Time frame: 6 months
Population: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Eligible Patients | Feasibility of Implementation | 51 Participants |
| Approached Patients | Feasibility of Implementation | 51 Participants |
| Enrolled Patients | Feasibility of Implementation | 51 Participants |
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).
Time frame: 60 days
Population: Of 51 completed participants, 21(41.2%) completed the 60-day MAUQ.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Eligible Patients | Perceived Value of Disease Management Platform | The app was easy to use | 6 score on a scale |
| Eligible Patients | Perceived Value of Disease Management Platform | It was easy for me to learn to use the app | 7 score on a scale |
| Eligible Patients | Perceived Value of Disease Management Platform | I like the interface of the app | 6 score on a scale |
| Eligible Patients | Perceived Value of Disease Management Platform | The information in the app was well organized, so I could easily find the information I needed | 6 score on a scale |
| Eligible Patients | Perceived Value of Disease Management Platform | I feel comfortable using this app in social settings | 6 score on a scale |
| Eligible Patients | Perceived Value of Disease Management Platform | The amount of time involved in using this app has been fitting for me | 6 score on a scale |
| Eligible Patients | Perceived Value of Disease Management Platform | I would use this app again | 6 score on a scale |
| Eligible Patients | Perceived Value of Disease Management Platform | Overall, I am satisfied with this app | 6 score on a scale |
| Eligible Patients | Perceived Value of Disease Management Platform | Whenever I made a mistake using the app, I could recover easily and quickly | 6 score on a scale |
| Eligible Patients | Perceived Value of Disease Management Platform | This mHealth app provides an acceptable way to receive healthcare services | 6 score on a scale |
| Eligible Patients | Perceived Value of Disease Management Platform | The app adequately acknowledged and provided information to let me know the progress of my action | 6 score on a scale |
| Eligible Patients | Perceived Value of Disease Management Platform | The navigation was consistent when moving between screens | 6 score on a scale |
| Eligible Patients | Perceived Value of Disease Management Platform | The interface of the app allowed me to use all the functions offered by the app | 6 score on a scale |
| Eligible Patients | Perceived Value of Disease Management Platform | This app has all the functions and capabilities I expected it to have | 6 score on a scale |
| Eligible Patients | Perceived Value of Disease Management Platform | The app would be useful for my health and wellbeing | 6 score on a scale |
| Eligible Patients | Perceived Value of Disease Management Platform | The app improved my access to healthcare services | 6 score on a scale |
| Eligible Patients | Perceived Value of Disease Management Platform | The app helped me manage my health effectively | 6 score on a scale |
| Eligible Patients | Perceived Value of Disease Management Platform | The app made it convenient for me to communicate with my healthcare provider | 6 score on a scale |
| Eligible Patients | Perceived Value of Disease Management Platform | Using the app, I had many more opportunities to interact with my healthcare provider | 6 score on a scale |
| Eligible Patients | Perceived Value of Disease Management Platform | I felt confident that any information I sent to my provider using the app would be received | 6 score on a scale |
| Eligible Patients | Perceived Value of Disease Management Platform | I felt comfortable communicating with my healthcare provider using the app | 6 score on a scale |
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.
Time frame: 60 days
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Eligible Patients | Disease Management Platform Engagement | Number of days participants engaged with the platform during the first 30 days of the study period | 22 days |
| Eligible Patients | Disease Management Platform Engagement | Number of days participants engaged with the platform over the 60-day study period | 44 days |
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.
Time frame: 60 days
Population: Of the 51 participants who completed the study, 29 participants completed at least two surveys of the baseline and 30- and 60-day KCCQs.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eligible Patients | Health Status Change With Use of Disease Management Platform | Number of participants whose score decreased by at least 15 points | 2 participants |
| Eligible Patients | Health Status Change With Use of Disease Management Platform | Number of participants whose score decreased by at least 10 points | 2 participants |
| Eligible Patients | Health Status Change With Use of Disease Management Platform | Number of participants whose score decreased by at least 5 points | 5 participants |
| Eligible Patients | Health Status Change With Use of Disease Management Platform | Number of participants whose score did not change | 6 participants |
| Eligible Patients | Health Status Change With Use of Disease Management Platform | Number of participants whose score increased by at least 5 points | 18 participants |
| Eligible Patients | Health Status Change With Use of Disease Management Platform | Number of participants whose score increased by at least 10 points | 9 participants |
| Eligible Patients | Health Status Change With Use of Disease Management Platform | Number of participants whose score increased by at least 15 points | 9 participants |