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The Effect of the MedSentry System on Medication Adherence

Primary Purpose

Heart Failure

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MedSentry System
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure focused on measuring Heart Failure, Congestive Heart Failure, Medication Adherence, Medication Compliance, Telemedicine, Telehealth

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

MedSentry System

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
March 18, 2013
Last Updated
August 29, 2020
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01814696
Brief Title
The Effect of the MedSentry System on Medication Adherence
Official Title
The Effect of the MedSentry System on Medication Adherence for Patients With Congestive Heart Failure: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment and reached number needed for analysis.
Study Start Date
March 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, Congestive Heart Failure, Medication Adherence, Medication Compliance, Telemedicine, Telehealth

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Subjects will continue to receive usual medical care from their doctor(s).
Arm Title
MedSentry System
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
MedSentry System
Other Intervention Name(s)
MedSentry pillbox, Electronic pillbox, Pillbox
Intervention Description
Subjects will use the MedSentry System and electronic pillbox, to manage their medications.
Primary Outcome Measure Information:
Title
Medical Outcomes Study (MOS) "Adhere"
Description
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
Secondary Outcome Measure Information:
Title
Number of Participants With 1 or More Emergency Department (ED) Visits.
Time Frame
3 months
Title
Number of Participants With 1 or More Hospitalizations.
Time Frame
3 months
Title
Number of Emergency Department (ED) Visits.
Time Frame
3 months
Title
Number of Hospitalization Visits.
Time Frame
3 months
Title
Hospitalization, Length of Stay (Days)
Time Frame
3 months
Title
Minnesota Living With Heart Failure Questionnaire (MLHFQ) Total Summary Score
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kamal Jethwani, MD, MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27154462
Citation
Hale TM, Jethwani K, Kandola MS, Saldana F, Kvedar JC. A Remote Medication Monitoring System for Chronic Heart Failure Patients to Reduce Readmissions: A Two-Arm Randomized Pilot Study. J Med Internet Res. 2016 Apr 17;18(5):e91. doi: 10.2196/jmir.5256. Erratum In: J Med Internet Res. 2019 Feb 05;21(2):e13125.
Results Reference
derived

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The Effect of the MedSentry System on Medication Adherence

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