Trial Outcomes & Findings for Automated Hovering to Improve Medication Adherence Among Myocardial Infarction Patients (Heartstrong) (NCT NCT01800201)

NCT ID: NCT01800201

Last Updated: 2020-01-18

Results Overview

Primary outcome variable(s): 1- year survival probability rate for vascular inpatient readmission or death

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 1509 participants
• Primary outcome timeframe: Date of enrollment + 12 months
• Results posted on: 2020-01-18

Participant Flow

Participants were recruited by University of Pennsylvania research staff from March 2013 through January 2015 and followed for one year.

No enrolled participants were excluded from the study before arm assignment

Participant milestones

Measure	Control The control group will have their claims data analyzed for a 12 month period. We will be examining these data for hospital admissions, new vascular events (AMI, stroke, acute coronary syndrome admission), or repeat or new cardiovascular procedures.	Intervention The intervention group (1) will use the GlowCaps, a remote monitoring and reminder pill bottle; (2) will be assigned an engagement advisor from the study team; (3) asked to provide the study team with names and contact information of up to 3 family members or friends as support partners for medication adherence. The study team will contact these people in order listed until 1 agrees to serve in this role; (4) will select a 2-digit lucky number to be used as part of the sweepstakes-based engagement incentives in which eligibility to win will be conditional on medication adherence; and (5) will determine their preferences for Way to Health platform communication methods during the study. The group receiving the program intervention will also have their claims data analyzed for the 12 months post-enrollment.
Overall Study STARTED	506	1003
Overall Study COMPLETED	503	1000
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Measure	Control The control group will have their claims data analyzed for a 12 month period. We will be examining these data for hospital admissions, new vascular events (AMI, stroke, acute coronary syndrome admission), or repeat or new cardiovascular procedures.	Intervention The intervention group (1) will use the GlowCaps, a remote monitoring and reminder pill bottle; (2) will be assigned an engagement advisor from the study team; (3) asked to provide the study team with names and contact information of up to 3 family members or friends as support partners for medication adherence. The study team will contact these people in order listed until 1 agrees to serve in this role; (4) will select a 2-digit lucky number to be used as part of the sweepstakes-based engagement incentives in which eligibility to win will be conditional on medication adherence; and (5) will determine their preferences for Way to Health platform communication methods during the study. The group receiving the program intervention will also have their claims data analyzed for the 12 months post-enrollment.
Overall Study Withdrawal by Subject	2	0
Overall Study patient privacy concerns	1	1
Overall Study did not want to use device	0	1
Overall Study PI withdrawal, cognitive concerns	0	1

Baseline Characteristics

Automated Hovering to Improve Medication Adherence Among Myocardial Infarction Patients (Heartstrong)

Baseline characteristics by cohort

Measure	Control n=503 Participants The control group will have their claims data analyzed for a 12 month period. We will be examining these data for hospital admissions, new vascular events (AMI, stroke, acute coronary syndrome admission), or repeat or new cardiovascular procedures.	Intervention n=1000 Participants The intervention group (1) will use the GlowCaps, a remote monitoring and reminder pill bottle; (2) will be assigned an engagement advisor from the study team; (3) asked to provide the study team with names and contact information of up to 3 family members or friends as support partners for medication adherence. The study team will contact these people in order listed until 1 agrees to serve in this role; (4) will select a 2-digit lucky number to be used as part of the sweepstakes-based engagement incentives in which eligibility to win will be conditional on medication adherence; and (5) will determine their preferences for Way to Health platform communication methods during the study. The group receiving the program intervention will also have their claims data analyzed for the 12 months post-enrollment.	Total n=1503 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	332 Participants n=5 Participants	601 Participants n=7 Participants	933 Participants n=5 Participants
Age, Categorical >=65 years	171 Participants n=5 Participants	399 Participants n=7 Participants	570 Participants n=5 Participants
Age, Continuous	60.6 years STANDARD_DEVIATION 10.2 • n=5 Participants	61.2 years STANDARD_DEVIATION 10.4 • n=7 Participants	61.0 years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	190 Participants n=5 Participants	343 Participants n=7 Participants	533 Participants n=5 Participants
Sex: Female, Male Male	313 Participants n=5 Participants	657 Participants n=7 Participants	970 Participants n=5 Participants
Region of Enrollment United States	503 participants n=5 Participants	1000 participants n=7 Participants	1503 participants n=5 Participants

PRIMARY outcome

Timeframe: Date of enrollment + 12 months

Primary outcome variable(s): 1- year survival probability rate for vascular inpatient readmission or death

Outcome measures

Measure	Control n=503 Participants The control group will have their claims data analyzed for a 12 month period. We will be examining these data for hospital admissions, new vascular events (AMI, stroke, acute coronary syndrome admission), or repeat or new cardiovascular procedures.	Intervention n=1000 Participants The intervention group (1) will use GlowCaps, a remote monitoring and reminder pill bottle; (2) assigned an engagement advisor from the study team; (3) asked to provide study team with names and contact information of up to 3 family members or friends as support partners for med adherence. The study team will contact these people in order listed until 1 agrees to this role; (4) will select a 2-digit lucky number to be used as part of the sweepstakes-based engagement incentives in which eligibility to win will be conditional on med adherence; and (5) will determine preferences for Way to Health platform communication methods.The group receiving the program intervention will also have their claims data analyzed for the 12 months post-enrollment.
1 -Year Survival Probability Rate: Vascular Readmissions or Death	.91 proportion of participants	.91 proportion of participants

SECONDARY outcome

Timeframe: Date of enrollment + 12 months

1 year survival probability rate for all cause readmissions

Outcome measures

Measure	Control n=503 Participants The control group will have their claims data analyzed for a 12 month period. We will be examining these data for hospital admissions, new vascular events (AMI, stroke, acute coronary syndrome admission), or repeat or new cardiovascular procedures.	Intervention n=1000 Participants The intervention group (1) will use GlowCaps, a remote monitoring and reminder pill bottle; (2) assigned an engagement advisor from the study team; (3) asked to provide study team with names and contact information of up to 3 family members or friends as support partners for med adherence. The study team will contact these people in order listed until 1 agrees to this role; (4) will select a 2-digit lucky number to be used as part of the sweepstakes-based engagement incentives in which eligibility to win will be conditional on med adherence; and (5) will determine preferences for Way to Health platform communication methods.The group receiving the program intervention will also have their claims data analyzed for the 12 months post-enrollment.
1 Year Survival Probability Rate All Cause Readmissions	.65 proportion of participants	.69 proportion of participants

SECONDARY outcome

Timeframe: Date of enrollment + 12 months

This is the number of vascular inpatient admission events control vs. intervention

Outcome measures

Measure	Control n=503 Participants The control group will have their claims data analyzed for a 12 month period. We will be examining these data for hospital admissions, new vascular events (AMI, stroke, acute coronary syndrome admission), or repeat or new cardiovascular procedures.	Intervention n=1000 Participants The intervention group (1) will use GlowCaps, a remote monitoring and reminder pill bottle; (2) assigned an engagement advisor from the study team; (3) asked to provide study team with names and contact information of up to 3 family members or friends as support partners for med adherence. The study team will contact these people in order listed until 1 agrees to this role; (4) will select a 2-digit lucky number to be used as part of the sweepstakes-based engagement incentives in which eligibility to win will be conditional on med adherence; and (5) will determine preferences for Way to Health platform communication methods.The group receiving the program intervention will also have their claims data analyzed for the 12 months post-enrollment.
Total Vascular Inpatient Readmissions	62 readmissions	119 readmissions

SECONDARY outcome

Timeframe: 12 months

Calculated by the proportion of days in which a patient has an active medication for all three medications (statin, beta blocker and antiplatelet). It is not the weighted average of the individual medication. This reflects the "intermediate" definition of adherence: our intermediate definition assumed that patients had been prescribed a medication for the entire study period if they ever filled that medication after discharge

Outcome measures

Measure	Control n=246 Participants The control group will have their claims data analyzed for a 12 month period. We will be examining these data for hospital admissions, new vascular events (AMI, stroke, acute coronary syndrome admission), or repeat or new cardiovascular procedures.	Intervention n=516 Participants The intervention group (1) will use GlowCaps, a remote monitoring and reminder pill bottle; (2) assigned an engagement advisor from the study team; (3) asked to provide study team with names and contact information of up to 3 family members or friends as support partners for med adherence. The study team will contact these people in order listed until 1 agrees to this role; (4) will select a 2-digit lucky number to be used as part of the sweepstakes-based engagement incentives in which eligibility to win will be conditional on med adherence; and (5) will determine preferences for Way to Health platform communication methods.The group receiving the program intervention will also have their claims data analyzed for the 12 months post-enrollment.
Proportion of Days Covered (PDC) for a Subset of Patients for Whom we Have Prescription Information	.58 PDC, mean Standard Deviation 0.35	.61 PDC, mean Standard Deviation 0.33

Adverse Events

Control

Serious events: 37 serious events

Other events: 0 other events

Deaths: 4 deaths

Intervention

Serious events: 66 serious events

Other events: 0 other events

Deaths: 8 deaths

Serious adverse events

Measure	Control n=503 participants at risk The control group will have their claims data analyzed for a 12 month period. We will be examining these data for hospital admissions, new vascular events (AMI, stroke, acute coronary syndrome admission), or repeat or new cardiovascular procedures.	Intervention n=1000 participants at risk The intervention group (1) will use the GlowCaps, a remote monitoring and reminder pill bottle; (2) will be assigned an engagement advisor from the study team; (3) asked to provide the study team with names and contact information of up to 3 family members or friends as support partners for medication adherence. The study team will contact these people in order listed until 1 agrees to serve in this role; (4) will select a 2-digit lucky number to be used as part of the sweepstakes-based engagement incentives in which eligibility to win will be conditional on medication adherence; and (5) will determine their preferences for Way to Health platform communication methods during the study. The group receiving the program intervention will also have their claims data analyzed for the 12 months post-enrollment.
Cardiac disorders Intracranial Hemmorhage	0.00% 0/503 • 1509 participants were enrolled starting in March 2013 through January 2015 and observed for one year. 6 patients withdrew. Adverse event data was collected for 1503 participants during all 12 months of their participation. We only have a report of deaths from medical claims if the patient died in the hospital, as a result we did not report on deaths in our manuscript due to incomplete data.	0.50% 5/1000 • Number of events 7 • 1509 participants were enrolled starting in March 2013 through January 2015 and observed for one year. 6 patients withdrew. Adverse event data was collected for 1503 participants during all 12 months of their participation. We only have a report of deaths from medical claims if the patient died in the hospital, as a result we did not report on deaths in our manuscript due to incomplete data.
Renal and urinary disorders Liver Failure	0.20% 1/503 • Number of events 1 • 1509 participants were enrolled starting in March 2013 through January 2015 and observed for one year. 6 patients withdrew. Adverse event data was collected for 1503 participants during all 12 months of their participation. We only have a report of deaths from medical claims if the patient died in the hospital, as a result we did not report on deaths in our manuscript due to incomplete data.	0.10% 1/1000 • Number of events 1 • 1509 participants were enrolled starting in March 2013 through January 2015 and observed for one year. 6 patients withdrew. Adverse event data was collected for 1503 participants during all 12 months of their participation. We only have a report of deaths from medical claims if the patient died in the hospital, as a result we did not report on deaths in our manuscript due to incomplete data.
Cardiac disorders Heart Block	0.20% 1/503 • Number of events 1 • 1509 participants were enrolled starting in March 2013 through January 2015 and observed for one year. 6 patients withdrew. Adverse event data was collected for 1503 participants during all 12 months of their participation. We only have a report of deaths from medical claims if the patient died in the hospital, as a result we did not report on deaths in our manuscript due to incomplete data.	0.40% 4/1000 • Number of events 6 • 1509 participants were enrolled starting in March 2013 through January 2015 and observed for one year. 6 patients withdrew. Adverse event data was collected for 1503 participants during all 12 months of their participation. We only have a report of deaths from medical claims if the patient died in the hospital, as a result we did not report on deaths in our manuscript due to incomplete data.
Renal and urinary disorders Rhabdomyolysis	0.20% 1/503 • Number of events 1 • 1509 participants were enrolled starting in March 2013 through January 2015 and observed for one year. 6 patients withdrew. Adverse event data was collected for 1503 participants during all 12 months of their participation. We only have a report of deaths from medical claims if the patient died in the hospital, as a result we did not report on deaths in our manuscript due to incomplete data.	0.40% 4/1000 • Number of events 4 • 1509 participants were enrolled starting in March 2013 through January 2015 and observed for one year. 6 patients withdrew. Adverse event data was collected for 1503 participants during all 12 months of their participation. We only have a report of deaths from medical claims if the patient died in the hospital, as a result we did not report on deaths in our manuscript due to incomplete data.
Gastrointestinal disorders GI Hemmorhage/Ulcer	2.4% 12/503 • Number of events 16 • 1509 participants were enrolled starting in March 2013 through January 2015 and observed for one year. 6 patients withdrew. Adverse event data was collected for 1503 participants during all 12 months of their participation. We only have a report of deaths from medical claims if the patient died in the hospital, as a result we did not report on deaths in our manuscript due to incomplete data.	1.2% 12/1000 • Number of events 14 • 1509 participants were enrolled starting in March 2013 through January 2015 and observed for one year. 6 patients withdrew. Adverse event data was collected for 1503 participants during all 12 months of their participation. We only have a report of deaths from medical claims if the patient died in the hospital, as a result we did not report on deaths in our manuscript due to incomplete data.
Blood and lymphatic system disorders Syncope	1.2% 6/503 • Number of events 6 • 1509 participants were enrolled starting in March 2013 through January 2015 and observed for one year. 6 patients withdrew. Adverse event data was collected for 1503 participants during all 12 months of their participation. We only have a report of deaths from medical claims if the patient died in the hospital, as a result we did not report on deaths in our manuscript due to incomplete data.	1.3% 13/1000 • Number of events 16 • 1509 participants were enrolled starting in March 2013 through January 2015 and observed for one year. 6 patients withdrew. Adverse event data was collected for 1503 participants during all 12 months of their participation. We only have a report of deaths from medical claims if the patient died in the hospital, as a result we did not report on deaths in our manuscript due to incomplete data.
Cardiac disorders Bradycardia	2.8% 14/503 • Number of events 15 • 1509 participants were enrolled starting in March 2013 through January 2015 and observed for one year. 6 patients withdrew. Adverse event data was collected for 1503 participants during all 12 months of their participation. We only have a report of deaths from medical claims if the patient died in the hospital, as a result we did not report on deaths in our manuscript due to incomplete data.	2.7% 27/1000 • Number of events 29 • 1509 participants were enrolled starting in March 2013 through January 2015 and observed for one year. 6 patients withdrew. Adverse event data was collected for 1503 participants during all 12 months of their participation. We only have a report of deaths from medical claims if the patient died in the hospital, as a result we did not report on deaths in our manuscript due to incomplete data.
Blood and lymphatic system disorders Unspecified Hemmorhage	0.40% 2/503 • Number of events 2 • 1509 participants were enrolled starting in March 2013 through January 2015 and observed for one year. 6 patients withdrew. Adverse event data was collected for 1503 participants during all 12 months of their participation. We only have a report of deaths from medical claims if the patient died in the hospital, as a result we did not report on deaths in our manuscript due to incomplete data.	0.00% 0/1000 • 1509 participants were enrolled starting in March 2013 through January 2015 and observed for one year. 6 patients withdrew. Adverse event data was collected for 1503 participants during all 12 months of their participation. We only have a report of deaths from medical claims if the patient died in the hospital, as a result we did not report on deaths in our manuscript due to incomplete data.

Other adverse events

Adverse event data not reported

Additional Information

Noora Marcus

University of Pennsylvania

Phone: 215-746-4429

Email: noora.marcus@uphs.upenn.edu

Results disclosure agreements

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