- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02682251
Engaging Patients in Heart Failure Management
Study Overview
Detailed Description
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Indiana
-
Fort Wayne, Indiana, United States, 46845
- Parkview Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
FOCUS GROUPS
Inclusion Criteria:
Remotely monitored with CRT-CIED
- focus groups 1 & 2: implant ≤ 12 months
- focus groups 3 & 4: implant ≥ 12 months
- Current patient of PPG-Cardiology
- History of HFrEF (heart failure in the setting of reduced ejection fraction)
- Access to computer and internet
- *Ability to provide informed consent
*Age ≥ 18 years
- 5 and 6 must apply to caregivers, partners, and/or support persons
Exclusion Criteria:
- Not remotely monitored with CRT-CIED
- Not current patient of PPG-Cardiology
- No history of HFrEF
- Pacemaker dependent
- Does not have access to computer and internet
- *Inability to provide informed consent
- *Age < 18 years
*Does not meet inclusion criteria
- Only 6, 7, and 8 apply to caregivers, partners, and/or support persons
TECHNOLOGY TRIAL
Inclusion Criteria:
- Remotely monitored with Biotronik CRT-CIED for more than 60 days
- Ability to provide informed consent
- Age ≥ 18 years
- Willing to have MyChart or proxy to MyChart
- Current patient of PPG-Cardiology
- History of HFrEF
Exclusion Criteria:
- Do not have a Biotronik CRT
- Have a Biotronik CRT-CIED for less than 60 days
- Not being remotely monitored with a Biotronik CRT-CIED
- No history of HFrEF
- Inability to provide informed consent
- Age < 18 years
- Lack of internet access or otherwise unable to access MyChart
- Pacemaker dependency
- Does not meet inclusion criteria
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Heart Failure Patients with CRT-CIED
PHR Messaging to notify patient of device transmitted information (i.e. percentage LV pacing)
|
PHR messaging of data pertinent to chronic resynchronization therapy and heart failure management (i.e. percentage LV pacing).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Timeliness of calls to clinic for adjustment in therapy
Time Frame: 6 months during study
|
6 months during study
|
Patient engagement evaluated through patient survey
Time Frame: 6 months during study
|
6 months during study
|
Improved percentage of LV pacing
Time Frame: 6 months during study
|
6 months during study
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Tammy Toscos, PhD, Parkview Health
- Principal Investigator: Michael Mirro, MD, Parkview Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRC15-0904 BTK
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Congestive Heart Failure
-
Adnan Kastrati, MDBiotronik SE & Co. KGCompleted
-
Signature Medical, Inc.WithdrawnHeart Failure,Congestive
-
Echosense Ltd.WithdrawnCongestive Heart Failure (CHF)United States
-
Corthera, Inc.(formerly BAS Medical, Inc.), a member...TerminatedCongestive Heart Failure (CHF)Russian Federation
-
Meir Medical CenterUnknown
-
Nihon KohdenTerminatedHeart Failure,CongestiveUnited States
-
ELA Medical, Inc.Approved for marketing
-
Abbott Medical DevicesCompletedCongestive Heart Failure TreatedItaly
-
Echosense Ltd.Terminated
-
Magenta Medical Ltd.TerminatedCongestive Heart Failure | Heart Failure, Congestive | Acute Heart FailureCroatia, Belgium, Serbia
Clinical Trials on PHR Messaging
-
McMaster UniversityCanadian Institutes of Health Research (CIHR); McMaster Children's HospitalCompleted
-
University of IowaCompletedMedication Adherence | Health Behavior | Adverse Reaction to Drug | Physician-Patient RelationsUnited States
-
University of PittsburghAgency for Healthcare Research and Quality (AHRQ)CompletedCardiovascular RiskUnited States
-
Indiana UniversityNational Cancer Institute (NCI)Recruiting
-
The Cleveland ClinicNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
University of California, San FranciscoCompletedHIV Infections | Health LiteracyUnited States
-
Washington University School of MedicineNational Cancer Institute (NCI)CompletedSmoking Cessation | Cancer | Health BehaviorUnited States
-
University of MinnesotaAmerican Cancer Society, Inc.; Melanoma Research AllianceCompletedMelanoma (Skin)United States
-
Medical University of South CarolinaNational Cancer Institute (NCI)Active, not recruitingSmoking Cessation | Lung Cancer ScreeningUnited States
-
University of DelawareCompletedDiet, Healthy | Autonomic Nervous System | Affect | Nutrition Therapy | DieteticsUnited States