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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

Tracking Information
First Submitted Date  ICMJE January 27, 2016
First Posted Date  ICMJE February 15, 2016
Last Update Posted Date October 30, 2019
Actual Study Start Date  ICMJE February 2016
Actual Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2016)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Engaging Patients in Heart Failure Management
Official Title  ICMJE Engaging Patients in Heart Failure Management
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Congestive Heart Failure
Intervention  ICMJE Other: PHR Messaging
PHR messaging of data pertinent to chronic resynchronization therapy and heart failure management (i.e. percentage LV pacing).
Study Arms  ICMJE Experimental: Heart Failure Patients with CRT-CIED
PHR Messaging to notify patient of device transmitted information (i.e. percentage LV pacing)
Intervention: Other: PHR Messaging
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 30, 2019)
10
Original Estimated Enrollment  ICMJE
 (submitted: February 10, 2016)
160
Actual Study Completion Date  ICMJE October 5, 2019
Actual Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02682251
Other Study ID Numbers  ICMJE PRC15-0904 BTK
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data available.
Responsible Party Tammy Toscos, Parkview Health
Study Sponsor  ICMJE Parkview Health
Collaborators  ICMJE Biotronik, Inc.
Investigators  ICMJE
Principal Investigator: Tammy Toscos, PhD Parkview Health
Principal Investigator: Michael Mirro, MD Parkview Health
PRS Account Parkview Health
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP