The Effect of the MedSentry System on Medication Adherence

Study Overview
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Brief Summary
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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: The use of the MedSentry system will improve medication adherence in patients with a discharge diagnosis of HF. The improvement in adherence correlates with fewer hospitalizations and emergency department (ED) visits. The improvement in adherence correlates with better health-related quality of life.

Official Title
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The Effect of the MedSentry System on Medication Adherence for Patients With Congestive Heart Failure: A Pilot Study

Conditions
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Heart Failure

Intervention / Treatment
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* Device: MedSentry System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Subjects will continue to receive usual medical care from their doctor(s). | |
| Experimental: MedSentry System<br>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. | Device: MedSentry System<br>* Subjects will use the MedSentry System and electronic pillbox, to manage their medications.<br>* Other names: Pillbox;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Congestive Heart Failure, Medication Adherence, Medication Compliance, Telemedicine, Telehealth