Study of Reminding to Improve Medication Adherence in Heart Failure

Not Applicable

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Device 2 passive	Non-reminding	Device 2 will NOT remind patients to take medications
Device 1 active	iPhone or pillbox	Device 1 will remind patients to take their medications
Device 2 active	iPhone or pillbox	Device 2 will remind patients to take medications
Device 1 Passive	Non-reminding	Device 1 will NOT remind patients to take medications.

Primary Outcome Measures

Name	Time	Method
Medication Adherence	28 days	The percentage of prescribed medications recorded as taken by the medication reminding device.
Patient Acceptance	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.

Secondary Outcome Measures