The Effect of the MedSentry System on Medication Adherence

NCT01814696 | Terminated Results

• 1 other identifier: 2012-P-002181
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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. 1.The use of the MedSentry system will improve medication adherence in patients with a discharge diagnosis of HF.
2. 2.The improvement in adherence correlates with fewer hospitalizations and emergency department (ED) visits.
3. 3.The improvement in adherence correlates with better health-related quality of life.

Conditions

Heart Failure

Keywords

Heart Failure; Congestive Heart Failure; Medication Adherence; Medication Compliance; Telemedicine; Telehealth

Outcome Measures

Primary Outcomes (1)

• 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).

  3 months

Secondary Outcomes (6)

• Number of Participants With 1 or More Emergency Department (ED) Visits.

  3 months

• Number of Participants With 1 or More Hospitalizations.

  3 months

• Number of Emergency Department (ED) Visits.

  3 months

• Number of Hospitalization Visits.

  3 months

• Hospitalization, Length of Stay (Days)

  3 months

Study Arms (2)

Control

NO INTERVENTION

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

MedSentry System

EXPERIMENTAL

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

Interventions

MedSentry System DEVICE

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

Also known as: MedSentry pillbox, Electronic pillbox, Pillbox

MedSentry System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 27154462 DERIVED

MeSH Terms

Conditions

Heart Failure; Medication Adherence

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Limitations and Caveats

The initial goal was to enroll a total of 70 participants with 35 randomized to each of the two study arms. However, due to slow enrollment the study was ended early with 26 participants having completed enrollment and randomization.

Results Point of Contact

• Title: Kamal Jethwani, MD, MPH
• Organization: Partners Healthcare Connected Health Innovation

kjethwani@partners.org

617-724-3410

Study Officials

• Kamal Jethwani, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatologist

Study Record Dates

• First Submitted: March 18, 2013
• First Posted: March 20, 2013
• Study Start: March 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: October 1, 2014
• Last Updated: September 17, 2020
• Results First Posted: January 5, 2017

Record last verified: 2020-08

Locations

US (1)