Congestive Heart FailureNCT02682251
Engaging Patients in Heart Failure Management
A study testing PHR Messaging in people with Congestive Heart Failure, run by Parkview Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- PHR Messaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 5 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- *Ability to provide informed consent
- *Age ≥ 18 years
- 5 and 6 must apply to caregivers, partners, and/or support persons
- 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
Who cannot join
- 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
Show all 19Show fewer
- *Age < 18 years
- *Does not meet inclusion criteria
- Only 6, 7, and 8 apply to caregivers, partners, and/or support persons
- TECHNOLOGY TRIAL
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- PHR Messaging
- Keywords
- Cardiac Resynchronization Therapy Devices, Cardiac Resynchronization Therapy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHR MessagingOther
PHR messaging of data pertinent to chronic resynchronization therapy and heart failure management (i.e. percentage LV pacing).
| Study group | Role | What they receive |
|---|---|---|
| Heart Failure Patients with CRT-CIED | Experimental | PHR Messaging to notify patient of device transmitted information (i.e. percentage LV pacing) Receives: Other: PHR Messaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timeliness of calls to clinic for adjustment in therapy
Measured: 6 months during study
Patient engagement evaluated through patient survey
Measured: 6 months during study
Improved percentage of LV pacing
Measured: 6 months during study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionAug 2019
- Study completion5 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parkview Health
- Sponsor type
- University, hospital or other
- Collaborators
- Biotronik, Inc.
- Responsible party
- Principal investigator, Tammy Toscos, Parkview Health
- Investigators
- Tammy Toscos, PhD, Principal investigator, Parkview HealthMichael Mirro, MD, Principal investigator, Parkview Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02682251
- Sponsor's protocol ID
- PRC15-0904 BTK
- Status last verified
- Oct 2019
- First submitted
- 27 Jan 2016
- Last updated
- 30 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is no plan to make individual participant data available.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Patients in Heart Failure Management
- ClinicalTrials.gov ID
- NCT02682251
- Acronym / sponsor ID
- PRC15-0904 BTK
- Conditions
- Congestive Heart Failure
- Keywords
- Cardiac Resynchronization Therapy Devices, Cardiac Resynchronization Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Parkview HealthUniversity, hospital or other
- Collaborators
- Biotronik, Inc.
- Study start
- Feb 2016 (actual)
- Primary completion
- Aug 2019 (actual)
- Study completion
- 5 Oct 2019 (actual)
- First posted
- 15 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart Failure Patients with CRT-CIED | Experimental | Other: PHR MessagingPHR Messaging to notify patient of device transmitted information (i.e. percentage LV pacing) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Remotely monitored with CRT-CIED
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PHR MessagingPHR messaging of data pertinent to chronic resynchronization therapy and heart failure management (i.e. percentage LV pacing). | Other | Heart Failure Patients with CRT-CIED |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tammy Toscos, PhD principal investigator
Parkview Health
Michael Mirro, MD principal investigator
Parkview Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PHR Messaging in people with Congestive Heart Failure, run by Parkview Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timeliness of calls to clinic for adjustment in therapy (time frame: 6 months during study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2019.