Study of Reminding to Improve Medication Adherence in Heart Failure (Heart iRx)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Heart Failure |
Device: iPhone or pillbox Behavioral: Non-reminding |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Heart iRx This Short Non-descriptive Title is the Real Title |
- Patient Acceptance [ Time Frame: 28 days ] [ Designated as safety issue: No ]Patient ratings of their satisfaction with the device, ease of use, and other impressions.
- Medication adherence [ Time Frame: 28 days ] [ Designated as safety issue: No ]The percentage of prescribed medications recorded as taken by the medication reminding device.
| Estimated Enrollment: | 60 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Device 2 passive
Device 2 will NOT remind patients to take medications
|
Behavioral: Non-reminding
As a comparison, the devices will collect medication taking information without providing reminders.
|
|
Active Comparator: Device 2 active
Device 2 will remind patients to take medications
|
Device: iPhone or pillbox
People will be reminded to take their medications by a device that alerts the patient to the need to take a medication.
|
|
Active Comparator: Device 1 active
Device 1 will remind patients to take their medications
|
Device: iPhone or pillbox
People will be reminded to take their medications by a device that alerts the patient to the need to take a medication.
|
|
Placebo Comparator: Device 1 Passive
Device 1 will NOT remind patients to take medications.
|
Behavioral: Non-reminding
As a comparison, the devices will collect medication taking information without providing reminders.
|
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.
Eligibility| Ages Eligible for Study: | 45 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Ohio | |
| Akron City Hospital | Recruiting |
| Akron, Ohio, United States, 44304 | |
| Contact: Joel W Hughes, Ph.D. 330-672-7721 jhughes1@kent.edu | |
| Principal Investigator: Joel W Hughes, PhD | |
| Principal Investigator: | Joel W Hughes, PhD | Kent State University |
More Information
No publications provided
| Responsible Party: | Joel Hughes, Associate Professor, Kent State University |
| ClinicalTrials.gov Identifier: | NCT01463267 History of Changes |
| Other Study ID Numbers: | 194822-4 |
| Study First Received: | September 27, 2011 |
| Last Updated: | October 28, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Kent State University:
|
Heart Failure |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 21, 2013