Engaging Patients in Heart Failure Management
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|ClinicalTrials.gov Identifier: NCT02682251|
Recruitment Status : Completed
First Posted : February 15, 2016
Last Update Posted : October 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Congestive Heart Failure||Other: PHR Messaging||Not Applicable|
An interventional study to empower congestive heart failure patients who have a cardiac resynchronization therapy-cardiac implantable electronic device (CRT-CIED) by using a personal health record (PHR) to directly message them their device data and send alerts based on percent left ventricular pacing.
There will be three phases in this study. In the first phase the investigators will employ a user-centered design approach to better understand what types of information that patients who have a remotely monitored CRT-CIED would find beneficial towards understanding and managing their disease. The investigators also hope to uncover expectations for alert mechanisms and two-way messaging between provider and patient around CIED remote monitoring data. In the second phase the investigators will implement the PHR intervention as designed in phase 1. In the third phase of this study, the investigators will test the PHR intervention in a single arm, 6-month trial.
A maximum of 120 participants (including patients and their caregiver, partner, and/or support persons) will be enrolled in the focus groups for phase 1. A maximum of 10 patients will be enrolled in the design session to follow in phase 1. After building the intervention in phase 2, a maximum of 30 patients will be enrolled in the technology trial for phase 3. Enrollment is projected to be complete within six months for phase 1, and within one year for phase 3.
In phase 3, adult subjects (N=30) with a diagnosis of congestive heart failure undergoing chronic resynchronization therapy through their CIED will receive interventional messaging through their PHR regarding percent left ventricular pacing.
The study duration will commence at the time of informed consent documentation during the first focus group and conclude at the time of the last patient visit during the technology trial.
Impact of PHR messaging will be evaluated by timeliness of patient calls to clinic for adjustment in therapy, an improved percentage of LV pacing over 6 months compared to historical controls from the same clinic, as well as self-reported patient engagement. Timeliness of patient calls to clinic will be evaluated through record of patient calls to clinic 6 months prior to study and 6 months during study. Patient engagement will be evaluated through patient survey at start and end of study.
Patients will follow standard of care + intervention during study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Engaging Patients in Heart Failure Management|
|Actual Study Start Date :||February 2016|
|Actual Primary Completion Date :||August 2019|
|Actual Study Completion Date :||October 5, 2019|
Experimental: Heart Failure Patients with CRT-CIED
PHR Messaging to notify patient of device transmitted information (i.e. percentage LV pacing)
Other: PHR Messaging
PHR messaging of data pertinent to chronic resynchronization therapy and heart failure management (i.e. percentage LV pacing).
- Timeliness of calls to clinic for adjustment in therapy [ Time Frame: 6 months during study ]
- Patient engagement evaluated through patient survey [ Time Frame: 6 months during study ]
- Improved percentage of LV pacing [ Time Frame: 6 months during study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02682251
|United States, Indiana|
|Fort Wayne, Indiana, United States, 46845|
|Principal Investigator:||Tammy Toscos, PhD||Parkview Health|
|Principal Investigator:||Michael Mirro, MD||Parkview Health|