Skip to main content
OpenTrials
Completed

NCT Number: NCT02378571

Medication Adherence Telemonitoring to Reduce Heart Failure Readmissions

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medication adherence telemonitoring

Behavioral

The member of the study team will respond to adherence data using clinical judgment as they would if the information was obtained during clinical care. Specifically, when contacting nonadherent participants, the member of the study team will provide participants with feedback on their electronic adherence; will inquire about potential consequences of missed doses; and will assess and respond to reasons for missed doses.

Primary outcomes

  1. Percentage of days participants take the correct number of doses of their diuretic

    Time frame: 30 days post-discharge

    Loop diuretic adherence: Adherence to the diuretic medication will be electronically measured using GlowCaps (Vitality Inc.) in the 30 days after hospitalization. Medication adherence will be calculated as the percent of days participants take the correct number of doses of their diuretic. Days when participants are incapable of taking their medication from the GlowCap bottle (e.g., while hospitalized) will be censored from calculations.

Secondary outcomes

  1. Score on the Self Care Heart Failure Index

    Time frame: 30 days post-discharge

    Heart Failure Symptoms, Self-Efficacy for self-managing heart failure, and Self-Management Behaviors will be measured using Self Care Heart Failure Index

  2. Proportion very or extremely satisfied with heart failure care

    Time frame: 30 days post-discharge

    Satisfaction with Heart Failure Care will be assessed by asking participants "Overall, how satisfied are you with the care you have been receiving for your heart problems over the last 30 days?" Response options will include: "not at all satisfied", "a little satisfied", "very satisfied," and "extremely satisfied."

  3. Number of readmissions and emergency room visits

    Time frame: 30 days post-discharge

    Readmissions and emergency room visits will be assessed by contacting participants or their close contacts at 30 days. Hospital records will be reviewed to confirm readmissions, to determine the reason for readmission or emergency room visit (heart failure versus other), and to determine whether it was related to medication nonadherence.

  4. Proportion attending at least 1 scheduled outpatient clinic visit within 30 days of discharge

    Time frame: 30 days post-discharge

    Attendance at scheduled outpatient clinic visits will be assessed by contacting participants or their close contacts at 30 days. Hospital records will be reviewed, when available, to determine whether and how medication adherence was addressed during the visit.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • New York Presbyterian Hospital

Registry information

Official study title

Telemonitoring Adherence to Medications to Reduce Heart Failure Readmissions: A Pilot Randomized Clinical Trial

Acronym: TEAM-HF

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 4, 2015
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.