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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2011 by Joel Hughes, Kent State University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01463267
First Posted: November 1, 2011
Last Update Posted: November 1, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Summa Health System
Information provided by (Responsible Party):
Joel Hughes, Kent State University
  Purpose
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.

Condition Intervention
Heart Failure Device: iPhone or pillbox Behavioral: Non-reminding

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Heart iRx This Short Non-descriptive Title is the Real Title

Resource links provided by NLM:


Further study details as provided by Joel Hughes, Kent State University:

Primary Outcome Measures:
  • Patient Acceptance [ Time Frame: 28 days ]
    Patient ratings of their satisfaction with the device, ease of use, and other impressions.

  • Medication adherence [ Time Frame: 28 days ]
    The percentage of prescribed medications recorded as taken by the medication reminding device.


Estimated Enrollment: 60
Study Start Date: November 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01463267


Locations
United States, Ohio
Akron City Hospital Recruiting
Akron, Ohio, United States, 44304
Contact: Joel W Hughes, Ph.D.    330-672-7721    jhughes1@kent.edu   
Principal Investigator: Joel W Hughes, PhD         
Sponsors and Collaborators
Kent State University
Summa Health System
Investigators
Principal Investigator: Joel W Hughes, PhD Kent State University
  More Information

Responsible Party: Joel Hughes, Associate Professor, Kent State University
ClinicalTrials.gov Identifier: NCT01463267     History of Changes
Other Study ID Numbers: 194822-4
First Submitted: September 27, 2011
First Posted: November 1, 2011
Last Update Posted: November 1, 2011
Last Verified: October 2011

Keywords provided by Joel Hughes, Kent State University:
Heart Failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases