Medication Adherence Telemonitoring to Reduce Heart Failure Readmissions

NCT02378571 | Completed DMC

• 1 other identifier: AAAO3305
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Medication adherence; Hospital readmissions

Outcome Measures

Primary Outcomes (1)

• Percentage of days participants take the correct number of doses of their diuretic

  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.

  30 days post-discharge

Secondary Outcomes (4)

• Score on the Self Care Heart Failure Index

  30 days post-discharge

• Proportion very or extremely satisfied with heart failure care

  30 days post-discharge

• Number of readmissions and emergency room visits

  30 days post-discharge

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

  30 days post-discharge

Study Arms (2)

Usual care

NO INTERVENTION

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.

Medication adherence telemonitoring

EXPERIMENTAL

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.

Behavioral: Medication adherence telemonitoring

Interventions

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.

Medication adherence telemonitoring

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• New York Presbyterian Hospital: collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

• 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.

  PMID: 27818309 RESULT

MeSH Terms

Conditions

Heart Failure; Medication Adherence

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Ian M Kronish, MD, MPH

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: February 27, 2015
• First Posted: March 4, 2015
• Study Start: December 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2015
• Last Updated: January 23, 2018

Record last verified: 2018-01

Locations

US (1)