Study of Reminding to Improve Medication Adherence in Heart Failure

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Heart Failure

Intervention / Treatment
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* Device: iPhone or pillbox
* Behavioral: Non-reminding


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Acceptance | 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 | The percentage of prescribed medications recorded as taken by the medication reminding device. | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure