Medication Adherence Telemonitoring to Reduce Heart Failure Readmissions

NCT ID: NCT02378571

Last Updated: 2018-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-11-30

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Usual care

Participants assigned to usual care will also be provided with a GlowCap prior to discharge and will be instructed to take their loop diuretic from this bottle and to notify the study team about prescribed dose changes. This information, however, will solely be used to measure medication adherence and will not be provided to a member of the study team nor to any of the participants' health care providers until the completion of the study period, at least 1 month later. Participants will not be provided with any advice on heart failure adherence.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Medication adherence telemonitoring

At discharge, participants in the intervention group will be instructed to take their loop diuretic exclusively from the GlowCap in the manner prescribed by their physician. A study team member will review the adherence data on a daily basis (except holidays and weekends) during the first 7 days after discharge, and then on, at minimum, a weekly basis. The study team member 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.

Group Type: EXPERIMENTAL

Medication adherence telemonitoring

Intervention Type: 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.

Interventions

Medication adherence telemonitoring

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York Presbyterian Hospital

OTHER

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Ian Kronish

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ian M Kronish, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Medical Center

New York, New York, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 27818309 (View on PubMed)

Other Identifiers

AAAO3305

Identifier Type: -

Identifier Source: org_study_id