Trial Outcomes & Findings for Disease Management Platform for Heart Failure (DMP-HF) (NCT NCT04782973)

NCT ID: NCT04782973

Last Updated: 2025-03-05

Results Overview

Feasibility of implementing the AMAZE™ platform is assessed in terms of the number of patients who completed the study.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 70 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2025-03-05

Participant Flow

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)

Participant milestones

Measure	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.
Overall Study STARTED	70
Overall Study COMPLETED	51
Overall Study NOT COMPLETED	19

Reasons for withdrawal

Measure	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.
Overall Study Withdrawal by Subject	5
Overall Study Protocol Violation	6
Overall Study No Longer Eligible Post-Consent	8

Baseline Characteristics

Disease Management Platform for Heart Failure (DMP-HF)

Baseline characteristics by cohort

Measure	Intervention Group - AMAZE™ Disease Management Platform n=51 Participants 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.
Age, Customized Age Mean	65.9 years STANDARD_DEVIATION 12.9 • n=5 Participants
Sex/Gender, Customized Male	36 Participants n=5 Participants
Sex/Gender, Customized Female	15 Participants n=5 Participants
Race/Ethnicity, Customized White	46 Participants n=5 Participants
Race/Ethnicity, Customized Black	3 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=5 Participants
Clinical conditions and co-morbidities Hypertension	45 participants n=5 Participants
Clinical conditions and co-morbidities Coronary artery disease	39 participants n=5 Participants
Clinical conditions and co-morbidities Hyperlipidemia	36 participants n=5 Participants
Clinical conditions and co-morbidities Atrial fibrillation	29 participants n=5 Participants
Clinical conditions and co-morbidities Anemia	26 participants n=5 Participants
Clinical conditions and co-morbidities Depression	25 participants n=5 Participants
Clinical conditions and co-morbidities Chronic kidney disease	19 participants n=5 Participants
Clinical conditions and co-morbidities Chronic lung disease	18 participants n=5 Participants
Clinical conditions and co-morbidities Obstructive sleep apnea	18 participants n=5 Participants
Clinical conditions and co-morbidities Diabetes	16 participants n=5 Participants
Clinical conditions and co-morbidities Cancer	11 participants n=5 Participants
Clinical conditions and co-morbidities Cerebrovascular disease	10 participants n=5 Participants
Clinical conditions and co-morbidities Thyroid disorder	10 participants n=5 Participants
Clinical conditions and co-morbidities Peripheral artery disease event	9 participants n=5 Participants
Clinical conditions and co-morbidities Abdominal aortic aneurysm	3 participants n=5 Participants
Clinical conditions and co-morbidities Familial hypercholesterolemia	3 participants n=5 Participants
Clinical conditions and co-morbidities Cirrhosis	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Feasibility of implementing the AMAZE™ platform is assessed in terms of the number of patients who completed the study.

Outcome measures

Measure	Eligible Patients n=409 Participants Patients admitted to MGH Cardiology floors considered eligible following manual chart review of their electronic medical records.	Approached Patients n=167 Participants Eligible patients who were approached for recruitment to the study	Enrolled Patients n=70 Participants Patients who consented to participating in the study
Feasibility of Implementation	51 Participants	51 Participants	51 Participants

PRIMARY outcome

Timeframe: 60 days

Population: Of 51 completed participants, 21(41.2%) completed the 60-day MAUQ.

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).

Outcome measures

Measure	Eligible Patients n=21 Participants Patients admitted to MGH Cardiology floors considered eligible following manual chart review of their electronic medical records.	Approached Patients Eligible patients who were approached for recruitment to the study	Enrolled Patients Patients who consented to participating in the study
Perceived Value of Disease Management Platform I like the interface of the app	6 score on a scale Interval 4.5 to 7.0	—	—
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 Interval 5.0 to 6.0	—	—
Perceived Value of Disease Management Platform I feel comfortable using this app in social settings	6 score on a scale Interval 6.0 to 7.0	—	—
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 Interval 6.0 to 7.0	—	—
Perceived Value of Disease Management Platform I would use this app again	6 score on a scale Interval 6.0 to 7.0	—	—
Perceived Value of Disease Management Platform Overall, I am satisfied with this app	6 score on a scale Interval 5.5 to 6.0	—	—
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 Interval 5.0 to 6.5	—	—
Perceived Value of Disease Management Platform This mHealth app provides an acceptable way to receive healthcare services	6 score on a scale Interval 5.0 to 6.0	—	—
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 Interval 4.0 to 6.0	—	—
Perceived Value of Disease Management Platform The navigation was consistent when moving between screens	6 score on a scale Interval 6.0 to 7.0	—	—
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 Interval 5.0 to 6.0	—	—
Perceived Value of Disease Management Platform This app has all the functions and capabilities I expected it to have	6 score on a scale Interval 5.0 to 6.0	—	—
Perceived Value of Disease Management Platform The app would be useful for my health and wellbeing	6 score on a scale Interval 5.0 to 7.0	—	—
Perceived Value of Disease Management Platform The app improved my access to healthcare services	6 score on a scale Interval 5.0 to 7.0	—	—
Perceived Value of Disease Management Platform The app helped me manage my health effectively	6 score on a scale Interval 5.0 to 6.0	—	—
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 Interval 4.0 to 6.0	—	—
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 Interval 6.0 to 6.5	—	—
Perceived Value of Disease Management Platform I felt comfortable communicating with my healthcare provider using the app	6 score on a scale Interval 4.5 to 7.0	—	—
Perceived Value of Disease Management Platform The app was easy to use	6 score on a scale Interval 6.0 to 7.0	—	—
Perceived Value of Disease Management Platform It was easy for me to learn to use the app	7 score on a scale Interval 6.0 to 7.0	—	—
Perceived Value of Disease Management Platform The app made it convenient for me to communicate with my healthcare provider	6 score on a scale Interval 4.5 to 6.0	—	—

SECONDARY outcome

Timeframe: 60 days

Participants' engagement with the platform was measured in terms of daily logs completed and number of messages sent to the nurse navigator.

Outcome measures

Measure	Eligible Patients n=51 Participants Patients admitted to MGH Cardiology floors considered eligible following manual chart review of their electronic medical records.	Approached Patients Eligible patients who were approached for recruitment to the study	Enrolled Patients Patients who consented to participating in the study
Disease Management Platform Engagement Number of days participants engaged with the platform during the first 30 days of the study period	22 days Interval 11.0 to 28.0	—	—
Disease Management Platform Engagement Number of days participants engaged with the platform over the 60-day study period	44 days Interval 14.0 to 53.0	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Eligible Patients n=29 Participants Patients admitted to MGH Cardiology floors considered eligible following manual chart review of their electronic medical records.	Approached Patients Eligible patients who were approached for recruitment to the study	Enrolled Patients Patients who consented to participating in the study
Health Status Change With Use of Disease Management Platform Number of participants whose score decreased by at least 15 points	2 participants	—	—
Health Status Change With Use of Disease Management Platform Number of participants whose score decreased by at least 10 points	2 participants	—	—
Health Status Change With Use of Disease Management Platform Number of participants whose score decreased by at least 5 points	5 participants	—	—
Health Status Change With Use of Disease Management Platform Number of participants whose score did not change	6 participants	—	—
Health Status Change With Use of Disease Management Platform Number of participants whose score increased by at least 5 points	18 participants	—	—
Health Status Change With Use of Disease Management Platform Number of participants whose score increased by at least 10 points	9 participants	—	—
Health Status Change With Use of Disease Management Platform Number of participants whose score increased by at least 15 points	9 participants	—	—

Adverse Events

Intervention Group - AMAZE™ Disease Management Platform

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kaavya Paruchuri, MD

Massachusetts General Hospital

Phone: 617-726-1843

Email: kparuchuri@mgh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place