Clinical trial NCT02378571: Medication Adherence Telemonitoring to Reduce Heart Failure Readmissions
Official title: Telemonitoring Adherence to Medications to Reduce Heart Failure Readmissions: A Pilot Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Medication adherence
Hospital readmissions
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: New York Presbyterian Hospital
First posted: 2015-03-04
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall purpose of this project is to determine the feasibility of conducting a large scale randomized clinical trial that compares remote monitoring of adherence to loop diuretics using a wireless electronic pillcap with usual care among recently hospitalized heart failure patients. The long-term goal of this program of research is to determine the effect of the adherence telemonitoring intervention on medication adherence and hospital readmissions among recently hospitalized heart failure patients.

Detailed description: Approximately one in four patients hospitalized with heart failure is readmitted within 30 days of discharge and more than 50% are readmitted within 6 months of discharge. Heart failure admissions are a major contributor to the enormous health care costs associated with heart failure. Thus far, the identification of effective interventions that prevent unnecessary readmissions has remained elusive. As a result, there is a pressing need to identify novel, cost-effective approaches to reducing heart failure readmissions. A growing body of research suggests that poor adherence to heart failure medications is a major reason for preventable heart failure readmissions. In particular, loop diuretic medications are essential to preventing the cardiopulmonary system from becoming overloaded. Patients who have been recently hospitalized may be especially vulnerable to adherence problems as a result of the stress of the recent hospitalization which commonly induces sleep deprivation, nutritional deficiency, physical deconditioning, cognitive impairment, and even delirium. Recent advances in wireless health now enable us to remotely, unobtrusively, and objectively monitor adherence to heart failure medications in the post-discharge period. Early identification of non-adherence to loop diuretic medications has the prevention to prevent a volume overloaded state that leads to a heart failure readmission. As patients who are non-adherent to their loop diuretics may also be non-adherent to other recommended self-management behaviors, early identification of medication nonadherence may provide the context to identify other gaps in self-management. To test our hypothesis that it is feasible to conduct a randomized trial of wireless, medication adherence monitoring with feedback to patients and clinicians, the investigators will enroll 40 patients who are hospitalized for heart failure and discharged on a diuretic medication. Patients will be randomized to 1) usual heart failure care + telemonitoring adherence to diuretic medications (INT); N=20 or 2) usual heart failure care (CTR); N=20. All patients will be asked to take their diuretic medication from a standard pill bottle covered by an electronic pill cap (GlowCap), but only patients assigned to the intervention arm will have their adherence telemonitored by a study clinician in real-time. Patients will have their adherence to medications measured in this fashion for 30 days after discharge. Patients will be contacted at 30 days to determine if they have been hospitalized and to collect other self-reported outcomes data.

Eligibility criteria: Inclusion Criteria:

* Hospitalized for heart failure
* Prescribed loop diuretic medication at discharge

Exclusion Criteria:

* Age less than 21 years
* New York Heart Association Class IV heart failure
* Terminal illness (\<6 mo prognosis)
* Unable to self-administer medications due to mental illness or cognitive impairment
* Non-English/Spanish speaking
* Discharged to an institutional setting (e.g., nursing home)
* Cardiologist or primary care provider refusal
* Unavailable for follow-up
* No access to telephone
* Enrolled in another cardiac trial

Primary outcomes:
measure: Percentage of days participants take the correct number of doses of their diuretic
timeFrame: 30 days post-discharge
Secondary outcomes:
measure: Score on the Self Care Heart Failure Index
timeFrame: 30 days post-discharge
measure: Proportion very or extremely satisfied with heart failure care
timeFrame: 30 days post-discharge
measure: Number of readmissions and emergency room visits
timeFrame: 30 days post-discharge
measure: Proportion attending at least 1 scheduled outpatient clinic visit within 30 days of discharge
timeFrame: 30 days post-discharge
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Ian M Kronish, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gallagher BD, Moise N, Haerizadeh M, Ye S, Medina V, Kronish IM. Telemonitoring Adherence to Medications in Heart Failure Patients (TEAM-HF): A Pilot Randomized Clinical Trial. J Card Fail. 2017 Apr;23(4):345-349. doi: 10.1016/j.cardfail.2016.11.001. Epub 2016 Nov 3.