Engaging Patients in Heart Failure Management

NCT02682251 | Completed

• 1 other identifier: PRC15-0904 BTK
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Congestive Heart Failure

Keywords

Cardiac Resynchronization Therapy Devices; Cardiac Resynchronization Therapy

Outcome Measures

Primary Outcomes (3)

• Timeliness of calls to clinic for adjustment in therapy

  6 months during study

• Patient engagement evaluated through patient survey

  6 months during study

• Improved percentage of LV pacing

  6 months during study

Study Arms (1)

Heart Failure Patients with CRT-CIED

EXPERIMENTAL

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

Other: PHR Messaging

Interventions

PHR Messaging OTHER

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

Heart Failure Patients with CRT-CIED

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Parkview Health: lead
• Biotronik, Inc.: collaborator

Study Sites (1)

Parkview Health

Fort Wayne, Indiana, 46845, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Tammy Toscos, PhD

  Parkview Health

  PRINCIPAL INVESTIGATOR

• Michael Mirro, MD

  Parkview Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist, Informatics

Study Record Dates

• First Submitted: January 27, 2016
• First Posted: February 15, 2016
• Study Start: February 1, 2016
• Primary Completion: August 1, 2019
• Study Completion: October 5, 2019
• Last Updated: October 30, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)