The Effect of the MedSentry System on Medication Adherence

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01814696
• Other study ID #: 2012-P-002181
• Status: Terminated
• Phase: N/A
• Start date: March 2013
• Est. completion date: October 2014

Study information

• Verified date: August 2020
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: October 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants With 1 or More Emergency Department (ED) Visits.		3 months
Secondary	Number of Participants With 1 or More Hospitalizations.		3 months
Secondary	Number of Emergency Department (ED) Visits.		3 months
Secondary	Number of Hospitalization Visits.		3 months
Secondary	Hospitalization, Length of Stay (Days)		3 months
Secondary	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.	Baseline, end 3 months