The Effect of the MedSentry System on Medication Adherence

Mass General Brigham

Status: Terminated

Conditions: Heart Failure

Treatments: Device: MedSentry System

Study type: Interventional

Funder types: Other

Identifiers

NCT01814696

2012-P-002181

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Control

No Intervention group

Description:

Subjects will continue to receive usual medical care from their doctor(s).

MedSentry System

Experimental group

Description:

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.

Treatment:

Device: MedSentry System