Clinical trial NCT01463267: Study of Reminding to Improve Medication Adherence in Heart Failure
Official title: Heart iRx This Short Non-descriptive Title is the Real Title
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
Lead sponsor: Kent State University
Sponsor class: OTHER
Collaborators: name: Summa Health System
First posted: 2011-11-01
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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 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

Primary outcomes:
measure: Patient Acceptance
timeFrame: 28 days
measure: Medication Adherence
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Akron
country: United States
facility: Akron City Hospital
state: Ohio
Study officials:
affiliation: Kent State University
name: Joel W Hughes, PhD
role: PRINCIPAL_INVESTIGATOR
References: