The Effect of the MedSentry System on Medication Adherence

NCT ID: NCT01814696

Last Updated: 2020-09-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-10-31

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

MedSentry System

Intervention Type: DEVICE

Subjects will use the MedSentry System and electronic pillbox, to manage their medications.

Interventions

MedSentry System

Subjects will use the MedSentry System and electronic pillbox, to manage their medications.

Intervention Type: DEVICE

Other Intervention Names

MedSentry pillbox; Electronic pillbox; Pillbox

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Joseph C. Kvedar

Dermatologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kamal Jethwani, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 27154462 (View on PubMed)

Other Identifiers

2012-P-002181

Identifier Type: -

Identifier Source: org_study_id