Study of Reminding to Improve Medication Adherence in Heart Failure (Heart iRx)

November 5, 2020 updated by: Joel Hughes, Kent State University

Heart iRx This Short Non-descriptive Title is the Real Title

This study is being done to look at how people manage their heart failure. The investigators are testing two medication reminder systems and the investigators want to know which one people like better. The investigators also want to see if they have any effect on ease of managing medication in individuals with heart failure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A pilot and feasibility randomized trial of two medication reminder systems for patients with heart failure (HF). The investigators believe that medication reminder systems will improve adherence and will reduce the effects of cognitive impairment on medication adherence. The investigators believe that patients will accept and use a medication reminder system, but the investigators cannot specify which system will be preferred. Each has different features which may be perceived as more or less desirable.

The investigators will enroll 60 patients with HF and randomize them to four conditions in a 2 (device 1 versus device 2) by 2 (Active versus Passive) design. After enrollment in the trial, patients will be consented and will complete pretesting at Summa Health System in the Center for Clinical Trials. They will primarily undergo brief computerized cognitive testing, complete self-report measures (e.g., quality of life, depression, self-management related social support), and will give consent for medical information to be collected from their electronic medical record. They will then be randomized to condition. In-home training will be provided regarding how to use the equipment. Medication adherence will be monitored for 28 days, followed by an in-home post-test (all pre-test measures) during which the equipment is returned.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Akron, Ohio, United States, 44304
        • Akron City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 45-90 years of age
  • documented systolic or diastolic heart failure

Exclusion Criteria:

  • History of neurological disorder
  • moderate or severe head injury with greater than 10 min loss of consciousness
  • Past or current history of severe psychiatric illness. Specifically, psychotic disorders (e.g. schizophrenia) and bipolar disorder. Potential study participants will not be excluded on the basis of managed depressive or anxiety disorder. These conditions are common in HF patients and their exclusion may limit generalizability of findings.
  • 5 year past or current history of alcohol or drug abuse (defined by DSM-IV criteria)
  • History of learning disorder or developmental disability (defined by DSM-IV criteria)
  • Renal failure requiring dialysis
  • Current home telemonitoring program to assist with HF self-management
  • They do not have a land-line telephone
  • Cardiac surgery < 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Device 2 passive
Device 2 will NOT remind patients to take medications
Behavioral: Non-reminding
As a comparison, the devices will collect medication taking information without providing reminders.
Active Comparator: Device 2 active
Device 2 will remind patients to take medications
Device: iPhone or pillbox
People will be reminded to take their medications by a device that alerts the patient to the need to take a medication.
Active Comparator: Device 1 active
Device 1 will remind patients to take their medications
Device: iPhone or pillbox
People will be reminded to take their medications by a device that alerts the patient to the need to take a medication.
Placebo Comparator: Device 1 Passive
Device 1 will NOT remind patients to take medications.
Behavioral: Non-reminding
As a comparison, the devices will collect medication taking information without providing reminders.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Acceptance
Time Frame: 28 days
Patient ratings of their satisfaction with the device, ease of use, and other impressions. A survey was created for this study to assess individuals' evaluations of the device to which they were randomized (see Appendix 1). At the final study session, participants completed the questionnaire about their preference for the device they were assigned. The 14 items were summed into a total score reflecting their ultimate appraisal for the device. The range of possible scores was 14-70. A higher score is greater patient acceptance. Participants rated how much they agreed to each statement from strongly disagree to strongly agree. The statements assess factors such as helpfulness, improving quality of life, and satisfaction.
28 days
Medication Adherence
Time Frame: 28 days
The percentage of prescribed medications recorded as taken by the medication reminding device.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kent State University

Collaborators

Summa Health System

Investigators

  • Principal Investigator: Joel W Hughes, PhD, Kent State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

September 27, 2011

First Submitted That Met QC Criteria

October 28, 2011

First Posted (Estimate)

November 1, 2011

Study Record Updates

Last Update Posted (Actual)

November 27, 2020

Last Update Submitted That Met QC Criteria

November 5, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 194822-4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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