Trial Outcomes & Findings for The Effect of the MedSentry System on Medication Adherence (NCT NCT01814696)
NCT ID: NCT01814696
Last Updated: 2020-09-17
Results Overview
Subject reported medication adherence. The Medical Outcomes Study (MOS) "Adhere" medication adherence measure consists of a single question that asks participants "How often did you take your medications as prescribed during the past 4 weeks?" Responses are recoded into a dichotomous measure of nonadherent (none, a little, some of the time) and adherent (most, all of the time).
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
3 months
Results posted on
2020-09-17
Participant Flow
Participants were recruited from a list of HF patients who had successfully completed a HF telemonitoring program at Massachusetts General Hospital (MGH) or Brigham \& Women's Hospital (BWH) and had been hospitalized in the previous 24 months.
Participant milestones
| Measure |
Control
Subjects will continue to receive usual medical care from their doctor(s).
Subjects will follow their normal medication management routine.
|
Intervention
Subjects will continue to receive usual medical care from their doctor(s).
Intervention: Subjects will use the MedSentry System and electronic pillbox, to manage their medications.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
11
|
|
Overall Study
COMPLETED
|
13
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Control
Subjects will continue to receive usual medical care from their doctor(s).
Subjects will follow their normal medication management routine.
|
Intervention
Subjects will continue to receive usual medical care from their doctor(s).
Intervention: Subjects will use the MedSentry System and electronic pillbox, to manage their medications.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Randomized to wrong group
|
1
|
0
|
Baseline Characteristics
The Effect of the MedSentry System on Medication Adherence
Baseline characteristics by cohort
| Measure |
Control
n=14 Participants
Subjects will continue to receive usual medical care from their doctor(s).
|
Intervention
n=11 Participants
Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.
MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74.4 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
68.4 years
STANDARD_DEVIATION 11.8 • n=7 Participants
|
71.7 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
13 participants
n=5 Participants
|
9 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-White
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
11 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Marital Status
Married
|
7 participants
n=5 Participants
|
4 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Marital Status
Non-married
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Lives Alone
Lives Alone
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Lives Alone
Lives with Others in Household
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Education Level
Less than 1 year college
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Education Level
1 or more years of college
|
11 participants
n=5 Participants
|
7 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Internet User
Internet User
|
10 participants
n=5 Participants
|
6 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Internet User
Non-Internet User
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Mobile Phone Ownership
No mobile phone
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Mobile Phone Ownership
Cellphone
|
11 participants
n=5 Participants
|
7 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Mobile Phone Ownership
Smartphone
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Medical Outcomes Study (MOS) Adhere
Adherent
|
11 participants
n=5 Participants
|
7 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Medical Outcomes Study (MOS) Adhere
Non-adherent
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Using a Medication Reminder Tool
Using a medication reminder
|
11 participants
n=5 Participants
|
7 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Using a Medication Reminder Tool
Not using a medication reminder
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
NYHA Functional Classification
Class 1
|
11 participants
n=5 Participants
|
1 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
NYHA Functional Classification
Class 2
|
1 participants
n=5 Participants
|
9 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
NYHA Functional Classification
Class 3
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
NYHA Functional Classification
Class 4
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
NYHA Functional Classification
Unknown
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Self-Rated Health
Poor
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Self-Rated Health
Fair
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Self-Rated Health
Good
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Self-Rated Health
Very Good
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Self-Rated Health
Excellent
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Personal Health Questionnaire Depression Scale, 8-Items (PHQ-8)
|
3.5 units on a scale
STANDARD_DEVIATION 4.6 • n=5 Participants
|
6.8 units on a scale
STANDARD_DEVIATION 4.5 • n=7 Participants
|
5.0 units on a scale
STANDARD_DEVIATION 4.8 • n=5 Participants
|
|
Minnesota Living with Heart Failure Questionnaire (MLHFQ) Total Score
|
26.2 units on a scale
STANDARD_DEVIATION 23.1 • n=5 Participants
|
43.7 units on a scale
STANDARD_DEVIATION 25.9 • n=7 Participants
|
34.3 units on a scale
STANDARD_DEVIATION 25.6 • n=5 Participants
|
|
Minnesota Living with Heart Failure Questionnaire (MLHFQ) Physical Score
|
10.8 units on a scale
STANDARD_DEVIATION 11.4 • n=5 Participants
|
21.9 units on a scale
STANDARD_DEVIATION 11.8 • n=7 Participants
|
15.7 units on a scale
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Minnesota Living with Heart Failure Questionnaire (MLHFQ) Emotional Score
|
5.9 units on a scale
STANDARD_DEVIATION 6.2 • n=5 Participants
|
7.2 units on a scale
STANDARD_DEVIATION 7.7 • n=7 Participants
|
6.5 units on a scale
STANDARD_DEVIATION 6.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Participants who completed questions on enrollment and closeout survey.
Subject reported medication adherence. The Medical Outcomes Study (MOS) "Adhere" medication adherence measure consists of a single question that asks participants "How often did you take your medications as prescribed during the past 4 weeks?" Responses are recoded into a dichotomous measure of nonadherent (none, a little, some of the time) and adherent (most, all of the time).
Outcome measures
| Measure |
Control
n=13 Participants
Subjects will continue to receive usual medical care from their doctor(s).
|
Intervention
n=11 Participants
Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.
MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications.
|
|---|---|---|
|
Medical Outcomes Study (MOS) "Adhere"
Adherent
|
9 participants
|
8 participants
|
|
Medical Outcomes Study (MOS) "Adhere"
Non-adherent
|
4 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Intention to treat analysis.
Outcome measures
| Measure |
Control
n=14 Participants
Subjects will continue to receive usual medical care from their doctor(s).
|
Intervention
n=11 Participants
Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.
MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications.
|
|---|---|---|
|
Number of Participants With 1 or More Emergency Department (ED) Visits.
Heart Failure Related
|
3 participants
|
1 participants
|
|
Number of Participants With 1 or More Emergency Department (ED) Visits.
Non Heart Failure Related
|
4 participants
|
3 participants
|
|
Number of Participants With 1 or More Emergency Department (ED) Visits.
All Cause
|
7 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Intention to treat analysis.
Outcome measures
| Measure |
Control
n=14 Participants
Subjects will continue to receive usual medical care from their doctor(s).
|
Intervention
n=11 Participants
Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.
MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications.
|
|---|---|---|
|
Number of Participants With 1 or More Hospitalizations.
Heart Failure Related
|
4 participants
|
1 participants
|
|
Number of Participants With 1 or More Hospitalizations.
Non Heart Failure Related
|
4 participants
|
1 participants
|
|
Number of Participants With 1 or More Hospitalizations.
All Cause
|
7 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Intention to treat analysis.
Outcome measures
| Measure |
Control
n=14 Participants
Subjects will continue to receive usual medical care from their doctor(s).
|
Intervention
n=11 Participants
Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.
MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications.
|
|---|---|---|
|
Number of Emergency Department (ED) Visits.
All cause
|
7 participants
|
4 participants
|
|
Number of Emergency Department (ED) Visits.
Heart Failure Related
|
3 participants
|
1 participants
|
|
Number of Emergency Department (ED) Visits.
Non Heart Failure Related
|
4 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Intention to treat analysis.
Outcome measures
| Measure |
Control
n=14 Participants
Subjects will continue to receive usual medical care from their doctor(s).
|
Intervention
n=11 Participants
Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.
MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications.
|
|---|---|---|
|
Number of Hospitalization Visits.
All cause
|
8 participants
|
2 participants
|
|
Number of Hospitalization Visits.
Heart Failure Related
|
4 participants
|
1 participants
|
|
Number of Hospitalization Visits.
Non Heart Failure Related
|
4 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Intention to treat analysis.
Outcome measures
| Measure |
Control
n=14 Participants
Subjects will continue to receive usual medical care from their doctor(s).
|
Intervention
n=11 Participants
Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.
MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications.
|
|---|---|---|
|
Hospitalization, Length of Stay (Days)
All cause
|
2.34 days
Standard Deviation 3.13
|
0.36 days
Standard Deviation 1.21
|
|
Hospitalization, Length of Stay (Days)
Heart Failure Related
|
1.36 days
Standard Deviation 2.68
|
0.18 days
Standard Deviation 0.60
|
|
Hospitalization, Length of Stay (Days)
Non Heart Failure Related
|
1.07 days
Standard Deviation 2.06
|
0.18 days
Standard Deviation 0.60
|
SECONDARY outcome
Timeframe: Baseline, end 3 monthsHealth-related quality of life is measured using the Minnesota Living with Heart Failure Questionnaire (MLHFQ). The questionnaire consists of 21 items that assess the impact of HF and HF treatment on key physical, emotional, and social dimensions of a patient's life during the past four weeks. Responses are coded from 0 = does not apply and 1 = very little to 5 = very much. A higher score represents a greater negative HR-related impact on quality of life.
Outcome measures
| Measure |
Control
n=13 Participants
Subjects will continue to receive usual medical care from their doctor(s).
|
Intervention
n=11 Participants
Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.
MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications.
|
|---|---|---|
|
Minnesota Living With Heart Failure Questionnaire (MLHFQ) Total Summary Score
|
28.2 units on a scale
Standard Deviation 22.3
|
62.2 units on a scale
Standard Deviation 20.6
|
Adverse Events
Control
Serious events: 7 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control
n=14 participants at risk
Subjects will continue to receive usual medical care from their doctor(s).
|
Intervention
n=11 participants at risk
Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.
MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications.
|
|---|---|---|
|
Cardiac disorders
ED Visit
|
21.4%
3/14 • Number of events 3 • 3 months
Adverse Events were categorized as cardiac and non-cardiac types. Adverse Events classified as cardiac types during the study included: angina; wide complex tachycardia; automatic implantable automatic defibrillator firing; endocarditis; and dizzy, low blood pressure. Adverse Events classified as non-cardiac types during this study included: fell; cellulitis; confusion; fever, shortness of breath, asthma; and ear pain.
|
9.1%
1/11 • Number of events 1 • 3 months
Adverse Events were categorized as cardiac and non-cardiac types. Adverse Events classified as cardiac types during the study included: angina; wide complex tachycardia; automatic implantable automatic defibrillator firing; endocarditis; and dizzy, low blood pressure. Adverse Events classified as non-cardiac types during this study included: fell; cellulitis; confusion; fever, shortness of breath, asthma; and ear pain.
|
|
General disorders
ED Visit
|
28.6%
4/14 • Number of events 4 • 3 months
Adverse Events were categorized as cardiac and non-cardiac types. Adverse Events classified as cardiac types during the study included: angina; wide complex tachycardia; automatic implantable automatic defibrillator firing; endocarditis; and dizzy, low blood pressure. Adverse Events classified as non-cardiac types during this study included: fell; cellulitis; confusion; fever, shortness of breath, asthma; and ear pain.
|
27.3%
3/11 • Number of events 3 • 3 months
Adverse Events were categorized as cardiac and non-cardiac types. Adverse Events classified as cardiac types during the study included: angina; wide complex tachycardia; automatic implantable automatic defibrillator firing; endocarditis; and dizzy, low blood pressure. Adverse Events classified as non-cardiac types during this study included: fell; cellulitis; confusion; fever, shortness of breath, asthma; and ear pain.
|
|
Cardiac disorders
Hospitalization
|
28.6%
4/14 • Number of events 4 • 3 months
Adverse Events were categorized as cardiac and non-cardiac types. Adverse Events classified as cardiac types during the study included: angina; wide complex tachycardia; automatic implantable automatic defibrillator firing; endocarditis; and dizzy, low blood pressure. Adverse Events classified as non-cardiac types during this study included: fell; cellulitis; confusion; fever, shortness of breath, asthma; and ear pain.
|
9.1%
1/11 • Number of events 1 • 3 months
Adverse Events were categorized as cardiac and non-cardiac types. Adverse Events classified as cardiac types during the study included: angina; wide complex tachycardia; automatic implantable automatic defibrillator firing; endocarditis; and dizzy, low blood pressure. Adverse Events classified as non-cardiac types during this study included: fell; cellulitis; confusion; fever, shortness of breath, asthma; and ear pain.
|
|
General disorders
Hospitalization
|
28.6%
4/14 • Number of events 4 • 3 months
Adverse Events were categorized as cardiac and non-cardiac types. Adverse Events classified as cardiac types during the study included: angina; wide complex tachycardia; automatic implantable automatic defibrillator firing; endocarditis; and dizzy, low blood pressure. Adverse Events classified as non-cardiac types during this study included: fell; cellulitis; confusion; fever, shortness of breath, asthma; and ear pain.
|
9.1%
1/11 • Number of events 1 • 3 months
Adverse Events were categorized as cardiac and non-cardiac types. Adverse Events classified as cardiac types during the study included: angina; wide complex tachycardia; automatic implantable automatic defibrillator firing; endocarditis; and dizzy, low blood pressure. Adverse Events classified as non-cardiac types during this study included: fell; cellulitis; confusion; fever, shortness of breath, asthma; and ear pain.
|
Other adverse events
Adverse event data not reported
Additional Information
Kamal Jethwani, MD, MPH
Partners Healthcare Connected Health Innovation
Phone: 617-724-3410
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place