Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:46 PM
Study NCT ID:
NCT01463267
Status:
COMPLETED
Last Update Posted:
2020-11-27
First Post:
2011-09-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of Reminding to Improve Medication Adherence in Heart Failure
Sponsor:
Kent State University
Organization:
Study Overview
Official Title:
Heart iRx This Short Non-descriptive Title is the Real Title
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Heart iRx
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: