The Effect of the MedSentry System on Medication Adherence

Not Applicable

Terminated

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
MedSentry System	MedSentry System	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Hospitalization, Length of Stay (Days)	3 months
Number of Participants With 1 or More Emergency Department (ED) Visits.	3 months
Number of Emergency Department (ED) Visits.	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 Participants With 1 or More Hospitalizations.	3 months
Number of Hospitalization Visits.	3 months