Heart iRx This Short Non-descriptive Title is the Real Title
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Kent State University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Medication Adherence
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Joel Hughes
Associate Professor
Kent State University
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
Outcomes
Primary Outcomes
Medication Adherence
Time Frame: 28 days
The percentage of prescribed medications recorded as taken by the medication reminding device.
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.