Study of Reminding to Improve Medication Adherence in Heart Failure
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 45 - 90 |
| Updated: | 4/2/2016 |
| Start Date: | November 2010 |
| End Date: | September 2012 |
Heart iRx This Short Non-descriptive Title is the Real Title
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.
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.
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.
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.
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
We found this trial at
1
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