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The Effect of the MedSentry System on Medication Adherence

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ClinicalTrials.gov Identifier: NCT01814696
Recruitment Status : Terminated (Slow enrollment and reached number needed for analysis.)
First Posted : March 20, 2013
Results First Posted : January 5, 2017
Last Update Posted : September 17, 2020
Sponsor:
Information provided by (Responsible Party):
Joseph C. Kvedar, Massachusetts General Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Heart Failure Device: MedSentry System Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effect of the MedSentry System on Medication Adherence for Patients With Congestive Heart Failure: A Pilot Study
Study Start Date : March 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Number of Participants With 1 or More Emergency Department (ED) Visits. [ Time Frame: 3 months ]
  2. Number of Participants With 1 or More Hospitalizations. [ Time Frame: 3 months ]
  3. Number of Emergency Department (ED) Visits. [ Time Frame: 3 months ]
  4. Number of Hospitalization Visits. [ Time Frame: 3 months ]
  5. Hospitalization, Length of Stay (Days) [ Time Frame: 3 months ]
  6. 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01814696


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Kamal Jethwani, MD, MPH Massachusetts General Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Joseph C. Kvedar, Dermatologist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01814696    
Other Study ID Numbers: 2012-P-002181
First Posted: March 20, 2013    Key Record Dates
Results First Posted: January 5, 2017
Last Update Posted: September 17, 2020
Last Verified: August 2020
Keywords provided by Joseph C. Kvedar, Massachusetts General Hospital:
Heart Failure
Congestive Heart Failure
Medication Adherence
 Medication Compliance
Telemedicine
Telehealth
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases