Clinical trial NCT01814696: 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
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
Congestive Heart Failure
Medication Adherence
Medication Compliance
Telemedicine
Telehealth
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2013-03-20
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Medical Outcomes Study (MOS) "Adhere"
timeFrame: 3 months
Secondary outcomes:
measure: Number of Participants With 1 or More Emergency Department (ED) Visits.
timeFrame: 3 months
measure: Number of Participants With 1 or More Hospitalizations.
timeFrame: 3 months
measure: Number of Emergency Department (ED) Visits.
timeFrame: 3 months
measure: Number of Hospitalization Visits.
timeFrame: 3 months
measure: Hospitalization, Length of Stay (Days)
timeFrame: 3 months
measure: Minnesota Living With Heart Failure Questionnaire (MLHFQ) Total Summary Score
timeFrame: Baseline, end 3 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Kamal Jethwani, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.