The Effect of the MedSentry System on Medication Adherence

August 29, 2020 updated by: Joseph C. Kvedar, Massachusetts General Hospital

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Subjects will continue to receive usual medical care from their doctor(s).
Experimental: 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.
Device: MedSentry System
Subjects will use the MedSentry System and electronic pillbox, to manage their medications.
Other Names:
  • MedSentry pillbox
  • Electronic pillbox
  • Pillbox

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medical Outcomes Study (MOS) "Adhere"
Time Frame: 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).
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With 1 or More Emergency Department (ED) Visits.
Time Frame: 3 months
3 months
Number of Participants With 1 or More Hospitalizations.
Time Frame: 3 months
3 months
Number of Emergency Department (ED) Visits.
Time Frame: 3 months
3 months
Number of Hospitalization Visits.
Time Frame: 3 months
3 months
Hospitalization, Length of Stay (Days)
Time Frame: 3 months
3 months
Minnesota Living With Heart Failure Questionnaire (MLHFQ) Total Summary Score
Time Frame: 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.
Baseline, end 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

March 18, 2013

First Submitted That Met QC Criteria

March 18, 2013

First Posted (Estimate)

March 20, 2013

Study Record Updates

Last Update Posted (Actual)

September 17, 2020

Last Update Submitted That Met QC Criteria

August 29, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-P-002181

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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