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

Kent State University

Status: Completed

Conditions: Heart Failure

Treatments: Behavioral: Non-reminding; Device: iPhone or pillbox

Study type: Interventional

Funder types: Other

Identifiers

NCT01463267

194822-4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 45 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 4 patient groups, including a placebo group

Device 2 passive

Active Comparator group

Description:

Device 2 will NOT remind patients to take medications

Treatment:

Behavioral: Non-reminding

Device 2 active

Active Comparator group

Description:

Device 2 will remind patients to take medications

Treatment:

Device: iPhone or pillbox

Device 1 active

Active Comparator group

Description:

Device 1 will remind patients to take their medications

Treatment:

Device: iPhone or pillbox

Device 1 Passive

Placebo Comparator group

Description:

Device 1 will NOT remind patients to take medications.

Treatment:

Behavioral: Non-reminding