Engaging Patients in Heart Failure Management

NCT ID: NCT02682251

Last Updated: 2019-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2019-10-05

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.

Conditions

Congestive Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Heart Failure Patients with CRT-CIED

PHR Messaging to notify patient of device transmitted information (i.e. percentage LV pacing)

Group Type: EXPERIMENTAL

PHR Messaging

Intervention Type: OTHER

PHR messaging of data pertinent to chronic resynchronization therapy and heart failure management (i.e. percentage LV pacing).

Interventions

PHR Messaging

PHR messaging of data pertinent to chronic resynchronization therapy and heart failure management (i.e. percentage LV pacing).

Intervention Type: OTHER

Eligibility Criteria

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

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

TECHNOLOGY TRIAL

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. 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotronik, Inc.

INDUSTRY

Sponsor Role: collaborator

Parkview Health

OTHER

Sponsor Role: lead

Responsible Party

Tammy Toscos

Research Scientist, Informatics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tammy Toscos, PhD

Role: PRINCIPAL_INVESTIGATOR

Parkview Health

Michael Mirro, MD

Role: PRINCIPAL_INVESTIGATOR

Parkview Health

Locations

Parkview Health

Fort Wayne, Indiana, United States

Countries

United States

Other Identifiers

PRC15-0904 BTK

Identifier Type: -

Identifier Source: org_study_id