Not provided
Not provided
Not provided
Not provided
Not provided
Slow enrollment and reached number needed for analysis.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this pilot study to evaluate the effect of the MedSentry system, a multi-faceted medication adherence device and reminder system, on medication adherence and clinical outcomes in heart-failure (HF) patients. We will also evaluate the usability and satisfaction derived from using this system.
We hypothesize that:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Subjects will continue to receive usual medical care from their doctor(s). | |
| MedSentry System | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MedSentry System | Device | Subjects will use the MedSentry System and electronic pillbox, to manage their medications. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Medical Outcomes Study (MOS) "Adhere" | 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). | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With 1 or More Emergency Department (ED) Visits. | 3 months | |
| Number of Participants With 1 or More Hospitalizations. | 3 months | |
| Number of Emergency Department (ED) Visits. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kamal Jethwani, MD, MPH | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27154462 | Derived | Hale TM, Jethwani K, Kandola MS, Saldana F, Kvedar JC. A Remote Medication Monitoring System for Chronic Heart Failure Patients to Reduce Readmissions: A Two-Arm Randomized Pilot Study. J Med Internet Res. 2016 Apr 17;18(5):e91. doi: 10.2196/jmir.5256. |
Not provided
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Control | Subjects will continue to receive usual medical care from their doctor(s). Subjects will follow their normal medication management routine. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Control | Subjects will continue to receive usual medical care from their doctor(s). |
| BG001 | Intervention | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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 | Medical Outcomes Study (MOS) "Adhere" | 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). | Participants who completed questions on enrollment and closeout survey. | Posted | Number | participants | 3 months |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Subjects will continue to receive usual medical care from their doctor(s). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ED Visit | Cardiac disorders | Systematic Assessment |
Not provided
The initial goal was to enroll a total of 70 participants with 35 randomized to each of the two study arms. However, due to slow enrollment the study was ended early with 26 participants having completed enrollment and randomization.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kamal Jethwani, MD, MPH | Partners Healthcare Connected Health Innovation | 617-724-3410 | kjethwani@partners.org |
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 3 months |
| Number of Hospitalization Visits. | 3 months |
| Hospitalization, Length of Stay (Days) | 3 months |
| Minnesota Living With Heart Failure Questionnaire (MLHFQ) Total Summary Score | Health-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. | Baseline, end 3 months |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Marital Status | Number | participants |
|
| Lives Alone | Number | participants |
|
| Education Level | Number | participants |
|
| Internet User | Number | participants |
|
| Mobile Phone Ownership | Number | participants |
|
| Medical Outcomes Study (MOS) Adhere | Single Medication Adherence Measures, Medical Outcomes Study (MOS) "Adhere" | Number | participants |
|
| Using a Medication Reminder Tool | Number | participants |
|
| NYHA Functional Classification | This scale is a categorical measure of severity of heart failure. There are four categories ranging from 1-4 increasing in severity. | Number | participants |
|
| Self-Rated Health | Number | participants |
|
| Personal Health Questionnaire Depression Scale, 8-Items (PHQ-8) | The PHQ-8 is a commonly used measure of depression. Each of the 8-items is scored from 0 to 3 to generate a total score from 0 to 24. Generally accepted cut points for depression severity are 5-9 = mild, 10-14 = moderate, 15-19 = moderately severe, and 20-24 = severe. | Mean | Standard Deviation | units on a scale |
|
| Minnesota Living with Heart Failure Questionnaire (MLHFQ) Total Score | Health-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. | Mean | Standard Deviation | units on a scale |
|
| Minnesota Living with Heart Failure Questionnaire (MLHFQ) Physical Score | Health-related quality of life is measured using the Minnesota Living with Heart Failure Questionnaire (MLHFQ). The Physical Sub-scale is created from 8-items from the 21-items that make up the MLHFQ. The items assess the impact of HF and HF treatment on key physical 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. The sub-scale ranges in possible values from 0 to 40. A higher score represents a greater negative HR-related impact on quality of life. | Mean | Standard Deviation | units on a scale |
|
| Minnesota Living with Heart Failure Questionnaire (MLHFQ) Emotional Score | Health-related quality of life is measured using the Minnesota Living with Heart Failure Questionnaire (MLHFQ). The Emotional Sub-scale is created from 5-items from the 21-items that make up the MLHFQ. The items assess the impact of HF and HF treatment on key emotional 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. The sub-scale ranges in possible values from 0 to 25. A higher score represents a greater negative HR-related impact on quality of life. | Mean | Standard Deviation | units on a scale |
|
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.
|
|
|
| Secondary | Number of Participants With 1 or More Emergency Department (ED) Visits. | Intention to treat analysis. | Posted | Number | participants | 3 months |
|
|
|
|
| Secondary | Number of Participants With 1 or More Hospitalizations. | Intention to treat analysis. | Posted | Number | participants | 3 months |
|
|
|
|
| Secondary | Number of Emergency Department (ED) Visits. | Intention to treat analysis. | Posted | Number | participants | 3 months |
|
|
|
|
| Secondary | Number of Hospitalization Visits. | Intention to treat analysis. | Posted | Number | participants | 3 months |
|
|
|
|
| Secondary | Hospitalization, Length of Stay (Days) | Intention to treat analysis. | Posted | Mean | Standard Deviation | days | 3 months |
|
|
|
|
| Secondary | Minnesota Living With Heart Failure Questionnaire (MLHFQ) Total Summary Score | Health-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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, end 3 months |
|
|
|
|
| 7 |
| 14 |
| 0 |
| 14 |
| EG001 | Intervention | 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. | 3 | 11 | 0 | 11 |
| ED Visit | General disorders | Systematic Assessment |
|
| Hospitalization | Cardiac disorders | Systematic Assessment |
|
| Hospitalization | General disorders | Systematic Assessment |
|
Not provided
Not provided
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| All Cause |
|
| 1.000 |
| 2-Sided |
| Superiority or Other (legacy) |
| All cause ED visits | Fisher Exact | 0.677 | 2-Sided | Superiority or Other (legacy) |
| All Cause |
|
| 2-Sided |
| Superiority or Other (legacy) |
| Non Heart Failure Related |
|
| 0.413 |
| 2-Sided |
| Superiority or Other (legacy) |
| Non-heart failure ED visits | Wilcoxon rank-sum test | 0.944 | 2-Sided | Superiority or Other (legacy) |
| Non Heart Failure Related |
|
| 0.236 |
| 2-Sided |
| Superiority or Other (legacy) |
| Non heart failure related | Wilcoxon rank-sum test | 0.236 | 2-Sided | Superiority or Other (legacy) |
| Non Heart Failure Related |
|
| 0.196 |
| Superiority or Other (legacy) |
| Non heart failure related | Wilcoxon rank-sum test | 0.210 | 2-Sided | Superiority or Other (legacy) |