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Engaging Patients in Heart Failure Management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02682251
Recruitment Status : Completed
First Posted : February 15, 2016
Last Update Posted : October 30, 2019
Sponsor:
Collaborator:
Biotronik, Inc.
Information provided by (Responsible Party):
Tammy Toscos, Parkview Health

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Other: PHR Messaging Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
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).




Primary Outcome Measures :
  1. Timeliness of calls to clinic for adjustment in therapy [ Time Frame: 6 months during study ]
  2. Patient engagement evaluated through patient survey [ Time Frame: 6 months during study ]
  3. Improved percentage of LV pacing [ Time Frame: 6 months during study ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

FOCUS GROUPS

Inclusion Criteria:

  1. Remotely monitored with CRT-CIED

    • focus groups 1 & 2: implant ≤ 12 months
    • focus groups 3 & 4: implant ≥ 12 months
  2. Current patient of PPG-Cardiology
  3. History of HFrEF (heart failure in the setting of reduced ejection fraction)
  4. Access to computer and internet
  5. *Ability to provide informed consent
  6. *Age ≥ 18 years

    • 5 and 6 must apply to caregivers, partners, and/or support persons

Exclusion Criteria:

  1. Not remotely monitored with CRT-CIED
  2. Not current patient of PPG-Cardiology
  3. No history of HFrEF
  4. Pacemaker dependent
  5. Does not have access to computer and internet
  6. *Inability to provide informed consent
  7. *Age < 18 years
  8. *Does not meet inclusion criteria

    • Only 6, 7, and 8 apply to caregivers, partners, and/or support persons

TECHNOLOGY TRIAL

Inclusion Criteria:

  1. Remotely monitored with Biotronik CRT-CIED for more than 60 days
  2. Ability to provide informed consent
  3. Age ≥ 18 years
  4. Willing to have MyChart or proxy to MyChart
  5. Current patient of PPG-Cardiology
  6. History of HFrEF

Exclusion Criteria:

  1. Do not have a Biotronik CRT
  2. Have a Biotronik CRT-CIED for less than 60 days
  3. Not being remotely monitored with a Biotronik CRT-CIED
  4. No history of HFrEF
  5. Inability to provide informed consent
  6. Age < 18 years
  7. Lack of internet access or otherwise unable to access MyChart
  8. Pacemaker dependency
  9. Does not meet inclusion criteria

Information from the National Library of Medicine

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


Locations
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United States, Indiana
Parkview Health
Fort Wayne, Indiana, United States, 46845
Sponsors and Collaborators
Parkview Health
Biotronik, Inc.
Investigators
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Principal Investigator: Tammy Toscos, PhD Parkview Health
Principal Investigator: Michael Mirro, MD Parkview Health
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Responsible Party: Tammy Toscos, Research Scientist, Informatics, Parkview Health
ClinicalTrials.gov Identifier: NCT02682251    
Other Study ID Numbers: PRC15-0904 BTK
First Posted: February 15, 2016    Key Record Dates
Last Update Posted: October 30, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data available.
Keywords provided by Tammy Toscos, Parkview Health:
Cardiac Resynchronization Therapy Devices
Cardiac Resynchronization Therapy
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases