Heart Failure
Conditions
Keywords
Heart Failure, Congestive Heart Failure, Medication Adherence, Medication Compliance, Telemedicine, Telehealth
Brief summary
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: 1. The use of the MedSentry system will improve medication adherence in patients with a discharge diagnosis of HF. 2. The improvement in adherence correlates with fewer hospitalizations and emergency department (ED) visits. 3. The improvement in adherence correlates with better health-related quality of life.
Interventions
DEVICEMedSentry System
Subjects will use the MedSentry System and electronic pillbox, to manage their medications.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who have successfully completed the Partners Connected Cardiac Care Program (CCCP) * Take at least 3 and no more than 10 different daily medications (including both prescription and non-prescription/over the counter medications) to treat Heart Failure (HF) and other comorbid disorders. * Take medications no more than 4 specified times each day (i.e. morning, afternoon, early evening, bedtime). * The patient must be able to open a pill bottle independently. * The patient must be able to sort and manage their own medications. * Hospitalization within the last 24 months. * Have a telephone or cell phone. * Live in the greater Boston area. * The patients must speak, read and write English. * The patients must not be either vision or hearing impaired (i.e., unable to hear an alarm similar to a clock alarm or oven alarm). * Patient must have an Massachusetts General Hospital (MGH) affiliated care provider.
Exclusion criteria
* Dementia or other conditions precluding the participant from providing informed consent or from learning to use the MedSentry pillbox. * Home environment unsuitable for the MedSentry pillbox and other installed equipment. * Awaiting revascularization, cardiac resynchronization or heart transplant. * Patients with a coexisting terminal illness like cancer or Chronic Renal Failure (CRF) requiring dialysis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medical Outcomes Study (MOS) Adhere | 3 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With 1 or More Hospitalizations. | 3 months | — |
| Number of Emergency Department (ED) Visits. | 3 months | — |
| Number of Participants With 1 or More Emergency Department (ED) Visits. | 3 months | — |
| Hospitalization, Length of Stay (Days) | 3 months | — |
| Minnesota Living With Heart Failure Questionnaire (MLHFQ) Total Summary Score | Baseline, end 3 months | 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. |
| Number of Hospitalization Visits. | 3 months | — |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Control Subjects will continue to receive usual medical care from their doctor(s). | 14 |
| 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. | 11 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Randomized to wrong group | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Intervention | Total | Control |
|---|---|---|---|
| Age, Continuous | 68.4 years STANDARD_DEVIATION 11.8 | 71.7 years STANDARD_DEVIATION 11.2 | 74.4 years STANDARD_DEVIATION 10.4 |
| Education Level 1 or more years of college | 7 participants | 18 participants | 11 participants |
| Education Level Less than 1 year college | 4 participants | 7 participants | 3 participants |
| Internet User Internet User | 6 participants | 16 participants | 10 participants |
| Internet User Non-Internet User | 5 participants | 9 participants | 4 participants |
| Lives Alone Lives Alone | 4 participants | 10 participants | 6 participants |
| Lives Alone Lives with Others in Household | 7 participants | 15 participants | 8 participants |
| Marital Status Married | 4 participants | 11 participants | 7 participants |
| Marital Status Non-married | 7 participants | 14 participants | 7 participants |
| Medical Outcomes Study (MOS) Adhere Adherent | 7 participants | 18 participants | 11 participants |
| Medical Outcomes Study (MOS) Adhere Non-adherent | 4 participants | 7 participants | 3 participants |
| Minnesota Living with Heart Failure Questionnaire (MLHFQ) Emotional Score | 7.2 units on a scale STANDARD_DEVIATION 7.7 | 6.5 units on a scale STANDARD_DEVIATION 6.7 | 5.9 units on a scale STANDARD_DEVIATION 6.2 |
| Minnesota Living with Heart Failure Questionnaire (MLHFQ) Physical Score | 21.9 units on a scale STANDARD_DEVIATION 11.8 | 15.7 units on a scale STANDARD_DEVIATION 12.7 | 10.8 units on a scale STANDARD_DEVIATION 11.4 |
| Minnesota Living with Heart Failure Questionnaire (MLHFQ) Total Score | 43.7 units on a scale STANDARD_DEVIATION 25.9 | 34.3 units on a scale STANDARD_DEVIATION 25.6 | 26.2 units on a scale STANDARD_DEVIATION 23.1 |
| Mobile Phone Ownership Cellphone | 7 participants | 18 participants | 11 participants |
| Mobile Phone Ownership No mobile phone | 2 participants | 3 participants | 1 participants |
| Mobile Phone Ownership Smartphone | 2 participants | 4 participants | 2 participants |
| NYHA Functional Classification Class 1 | 1 participants | 12 participants | 11 participants |
| NYHA Functional Classification Class 2 | 9 participants | 10 participants | 1 participants |
| NYHA Functional Classification Class 3 | 1 participants | 2 participants | 1 participants |
| NYHA Functional Classification Class 4 | 0 participants | 0 participants | 0 participants |
| NYHA Functional Classification Unknown | 0 participants | 1 participants | 1 participants |
| Personal Health Questionnaire Depression Scale, 8-Items (PHQ-8) | 6.8 units on a scale STANDARD_DEVIATION 4.5 | 5.0 units on a scale STANDARD_DEVIATION 4.8 | 3.5 units on a scale STANDARD_DEVIATION 4.6 |
| Race/Ethnicity, Customized Non-White | 2 participants | 3 participants | 1 participants |
| Race/Ethnicity, Customized White | 9 participants | 22 participants | 13 participants |
| Region of Enrollment United States | 11 participants | 25 participants | 14 participants |
| Self-Rated Health Excellent | 0 participants | 1 participants | 1 participants |
| Self-Rated Health Fair | 5 participants | 11 participants | 6 participants |
| Self-Rated Health Good | 5 participants | 10 participants | 5 participants |
| Self-Rated Health Poor | 1 participants | 1 participants | 0 participants |
| Self-Rated Health Very Good | 0 participants | 2 participants | 2 participants |
| Sex: Female, Male Female | 4 Participants | 9 Participants | 5 Participants |
| Sex: Female, Male Male | 7 Participants | 16 Participants | 9 Participants |
| Using a Medication Reminder Tool Not using a medication reminder | 4 participants | 7 participants | 3 participants |
| Using a Medication Reminder Tool Using a medication reminder | 7 participants | 18 participants | 11 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 14 | 0 / 11 |
| serious Total, serious adverse events | 7 / 14 | 3 / 11 |
Outcome results
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).
Time frame: 3 months
Population: Participants who completed questions on enrollment and closeout survey.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control | Medical Outcomes Study (MOS) Adhere | Adherent | 9 participants |
| Control | Medical Outcomes Study (MOS) Adhere | Non-adherent | 4 participants |
| Intervention | Medical Outcomes Study (MOS) Adhere | Adherent | 8 participants |
| Intervention | Medical Outcomes Study (MOS) Adhere | Non-adherent | 3 participants |
p-value: 0.605Fisher Exact
Secondary
Hospitalization, Length of Stay (Days)
Time frame: 3 months
Population: Intention to treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Hospitalization, Length of Stay (Days) | Heart Failure Related | 1.36 days | Standard Deviation 2.68 |
| Control | Hospitalization, Length of Stay (Days) | All cause | 2.34 days | Standard Deviation 3.13 |
| Control | Hospitalization, Length of Stay (Days) | Non Heart Failure Related | 1.07 days | Standard Deviation 2.06 |
| Intervention | Hospitalization, Length of Stay (Days) | Heart Failure Related | 0.18 days | Standard Deviation 0.6 |
| Intervention | Hospitalization, Length of Stay (Days) | All cause | 0.36 days | Standard Deviation 1.21 |
| Intervention | Hospitalization, Length of Stay (Days) | Non Heart Failure Related | 0.18 days | Standard Deviation 0.6 |
Comparison: All causep-value: 0.034Wilcoxon rank-sum test
Comparison: Heart failure relatedp-value: 0.196Wilcoxon rank-sum test
Comparison: Non heart failure relatedp-value: 0.21Wilcoxon rank-sum test
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.
Time frame: Baseline, end 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Minnesota Living With Heart Failure Questionnaire (MLHFQ) Total Summary Score | 28.2 units on a scale | Standard Deviation 22.3 |
| Intervention | Minnesota Living With Heart Failure Questionnaire (MLHFQ) Total Summary Score | 62.2 units on a scale | Standard Deviation 20.6 |
p-value: 0.002t-test, 2 sided
Secondary
Number of Emergency Department (ED) Visits.
Time frame: 3 months
Population: Intention to treat analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control | Number of Emergency Department (ED) Visits. | All cause | 7 participants |
| Control | Number of Emergency Department (ED) Visits. | Heart Failure Related | 3 participants |
| Control | Number of Emergency Department (ED) Visits. | Non Heart Failure Related | 4 participants |
| Intervention | Number of Emergency Department (ED) Visits. | All cause | 4 participants |
| Intervention | Number of Emergency Department (ED) Visits. | Heart Failure Related | 1 participants |
| Intervention | Number of Emergency Department (ED) Visits. | Non Heart Failure Related | 3 participants |
Comparison: All causep-value: 0.497Wilcoxon rank-sum test
Comparison: Heart failure relatedp-value: 0.413Wilcoxon rank-sum test
Comparison: Non-heart failure ED visitsp-value: 0.944Wilcoxon rank-sum test
Secondary
Number of Hospitalization Visits.
Time frame: 3 months
Population: Intention to treat analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control | Number of Hospitalization Visits. | All cause | 8 participants |
| Control | Number of Hospitalization Visits. | Heart Failure Related | 4 participants |
| Control | Number of Hospitalization Visits. | Non Heart Failure Related | 4 participants |
| Intervention | Number of Hospitalization Visits. | All cause | 2 participants |
| Intervention | Number of Hospitalization Visits. | Heart Failure Related | 1 participants |
| Intervention | Number of Hospitalization Visits. | Non Heart Failure Related | 1 participants |
Comparison: All causep-value: 0.057Wilcoxon rank-sum test
Comparison: Heart failure relatedp-value: 0.236Wilcoxon rank-sum test
Comparison: Non heart failure relatedp-value: 0.236Wilcoxon rank-sum test
Secondary
Number of Participants With 1 or More Emergency Department (ED) Visits.
Time frame: 3 months
Population: Intention to treat analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control | Number of Participants With 1 or More Emergency Department (ED) Visits. | Heart Failure Related | 3 participants |
| Control | Number of Participants With 1 or More Emergency Department (ED) Visits. | Non Heart Failure Related | 4 participants |
| Control | Number of Participants With 1 or More Emergency Department (ED) Visits. | All Cause | 7 participants |
| Intervention | Number of Participants With 1 or More Emergency Department (ED) Visits. | Heart Failure Related | 1 participants |
| Intervention | Number of Participants With 1 or More Emergency Department (ED) Visits. | Non Heart Failure Related | 3 participants |
| Intervention | Number of Participants With 1 or More Emergency Department (ED) Visits. | All Cause | 4 participants |
Comparison: Heart failure related ED visitsp-value: 0.604Fisher Exact
Comparison: Non-heart failure related ED visitsp-value: 1Fisher Exact
Comparison: All cause ED visitsp-value: 0.677Fisher Exact
Secondary
Number of Participants With 1 or More Hospitalizations.
Time frame: 3 months
Population: Intention to treat analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control | Number of Participants With 1 or More Hospitalizations. | Heart Failure Related | 4 participants |
| Control | Number of Participants With 1 or More Hospitalizations. | Non Heart Failure Related | 4 participants |
| Control | Number of Participants With 1 or More Hospitalizations. | All Cause | 7 participants |
| Intervention | Number of Participants With 1 or More Hospitalizations. | Heart Failure Related | 1 participants |
| Intervention | Number of Participants With 1 or More Hospitalizations. | Non Heart Failure Related | 1 participants |
| Intervention | Number of Participants With 1 or More Hospitalizations. | All Cause | 1 participants |
p-value: 0.341Fisher Exact
p-value: 0.042Fisher Exact