Heart Failure and Reduced Ejection FractionNCT07084142
Developing a Digital Aid to Improve ICD Decisions
A study testing Online, patient-facing decision-making aid (app) with personalized risk information., Implantable Cardioverter Defibrillator (ICD) and Online, patient-facing decision-making app without personalized risk information. in people with Heart Failure and Reduced Ejection Fraction, run by Stanford University at 2 sites in United States.
Trial summary
Advanced heart failure, affecting 7 million Americans, has multiple causes and results in greatly increased risk of disability and death. A major problem is sudden cardiac death, when the damaged heart develops an abnormal pattern of electrical conduction that can result in cessation of heart activity. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Heart Failure and Reduced Ejection Fraction
- What is being tested?
- Online, patient-facing decision-making aid (app) with personalized risk information., Implantable Cardioverter Defibrillator (ICD) and Online, patient-facing decision-making app without personalized risk information.
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2025to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets or approximates minimal criteria for primary prevention ICD placement. ● Left Ventricular Ejection Fraction (LVEF) <35%.
- Clinical diagnosis of Heart Failure:
- Patients with severe ischemic dilated cardiomyopathy and underlying NYHA
- Class II or III Heart Failure, OR, Patients with severe nonischemic dilated cardiomyopathy and underlying NYHA Class II or III Heart Failure.
- Age ≥ 70 years old.
- Able to consent in English, Mandarin or Spanish and follow study instructions.
Who cannot join
- The exclusion criteria include any of the following:
- Past ICD implantation (not including pacemakers).
- Any indication for secondary prevention of SCD via ICD implantation.
- History of mechanical valve replacement.
- History of recent myocardial infarction within the last 40 days.
- History of recent revascularization within the past 90 days.
Show all 11Show fewer
- History of familial or genetic disorders with a high-risk of ventricular arrhythmias, such as the long QT syndrome (LQTS) or hypertrophic cardiomyopathy (HCM).
- Any factors contraindicating ICD placement.
- Less than 6 months life expectancy and other clinical consideration,
- Unwilling or unable to consider ICD,
- Any contraindications to ambulati
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Darlyne Esparza contact
United States2 sites, 2 recruiting
- Recruiting
Eastern Carolina University
Greenville, North Carolina, 27858
Elizabeth Jordan, 252-328-6131, JORDANE22@students.ecu.edu
Samuel Sears, PhD
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Daniel P Morin, MD, MPH, 415-476-4922, Daniel.Morin@ucsf.edu
Jacqueline Furrier, 415-476-4922, Jacqueline.Furrier@ucsf.edu
About this study
Official title: Developing "A Digital Shared Decision-Making Aid to Improve Patient-Centered Outcomes in Implantable Cardioverter-Defibrillator (ICD) Decisions Among Older Patients"
Advanced heart failure, affecting 7 million Americans, has multiple causes and results in greatly increased risk of disability and death. A major problem is sudden cardiac death, when the damaged heart develops an abnormal pattern of electrical conduction that can result in cessation of heart activity. While placement of an Implantable Cardioverter-Defibrillator (ICD) in a patient's chest can help prevent sudden cardiac death, these devices have several important downsides. This protocol focuses on development of a digital decision aid that helps heart failure patients make informed decisions that balance the benefits and downsides of ICD placement. This protocol covers the use of participant surveys, focus groups, and interviews to obtain the needed background information to guide the development of this digital tool, which will be subsequently tested against usual care in a randomized clinical trial. The study design is best described as a mixed methods evaluation and refinement of a digital app to improve ICD decision-making. In the future, the present protocol will be modified to create a new protocol that covers the needed human subjects requirements for performance of this clinical trial.
Read the detailed description
Advanced heart failure, affecting 7 million Americans, has multiple causes and results in greatly increased risk of disability and death. A major problem is sudden cardiac death, when the damaged heart develops an abnormal pattern of electrical conduction that can result in cessation of heart activity. While placement of an Implantable Cardioverter-Defibrillator (ICD) in a patient's chest can help prevent sudden cardiac death, these devices have several important downsides. This protocol focuses on development of a digital decision aid that helps heart failure patients make informed decisions that balance the benefits and downsides of ICD placement. This protocol covers the use of participant surveys, focus groups, and interviews to obtain the needed background information to guide the development of this digital tool, which will be subsequently tested against usual care in a randomized clinical trial. In the future, the present protocol will be modified to create a new protocol that covers the needed human subjects requirements for performance of this clinical trial.
Participants with heart failure who agree to participate will be recorded in a REDCap system database. The investigators will document in a recruitment tracking log all potentially eligible participants found to be ineligible or who decline participation. The reason for ineligibility or reason for decline will be captured along with age, gender, and race/ethnicity. At the time of their enrollment, the investigators will collect additional information from each participant about their employment status (full-time or part-time employment, no employment, retired), education (no postsecondary education, some postsecondary education), household size (living alone, living with at least one other person).
Participants with heart failure will be asked if they are willing to be interviewed, participate in focus groups, or complete surveys to determine their views on 1) which elements of patient outcome questionnaires are important to them; 2) which decision aid components or educational tools they like or find valuable. Interactions with participants will include open-ended interviews, focus groups, and surveys. These interviews, focus groups, and surveys will be conducted by study staff to help develop a patient-centric shared decision making software tool. Development will occur iteratively with new testing after any modifications. The same individuals may be asked to re-test the app following alterations.
Collaborating teams from UC San Francisco (Site PI: Daniel Morin, MD, MPH) and East Carolina University (Site PI: Samuel Sears, PhD) will join the study before the third month of operation. The participation of these clinical sites is not needed in the first steps on digital tool development. By successfully initiating the project at Stanford, the process of initiation at the clinical sites will be facilitated and is consistent with the mandated use of a single IRB for the three sites.
- Being tested
- Online, patient-facing decision-making aid (app) with personalized risk information., Implantable Cardioverter Defibrillator (ICD), Online, patient-facing decision-making app without personalized risk information.
- Keywords
- heart failure, HFrEF, sudden cardiac death, patient education, shared decision-making, arrhythmia, implantable cardioverter-defibrillator
- Medical subject headings
- Heart Failure, Systolic, Heart Failure, Death, Sudden, Cardiac, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online, patient-facing decision-making aid (app) with personalized risk information.Other
The online, patient-facing decision-making aid will have the following features:
- Clinical Data Input,
- Introduction via Animated Video,
- Common Questions,
- Check-In Quiz,
- Risk and Values Exploration based on patient specific information,
- Wrap-Up,
- Patient-Physician Worksheet,
These steps will be completed by the patient in advance of a provider visit where a shared-decision making process will decide whether an ICD is an appropriate sudden cardiac death-prevention strategy to pursue.
Implantable Cardioverter Defibrillator (ICD)Device
Some participants, in their course of medical care unrelated to the study intervention, will undergo implantation of an ICD.
Online, patient-facing decision-making app without personalized risk information.Other
The online, patient-facing decision-making aid will have the following features: 1) Clinical Data Input, 2) Introduction via Animated Video, 3) Common Questions, 4) Check-In Quiz, 5) Generic Risk and Values Exploration without patient specific information, 6) Wrap-Up, 7) Patient-Physician Worksheet, These steps will be completed by the patient in advance of a provider visit where a shared-decision making process will decide whether an ICD is an appropriate sudden cardiac death-prevention strategy to pursue.
| Study group | Role | What they receive |
|---|---|---|
| Exposure to digital decision-making app with personal risk information | Experimental | The participant will use the pre-visit, participant-facing app with personal risk information derived from participant characteristics. During a clinical encounter, the clinician will have access to an abbreviated clinician-facing digital tool that displays the same personalized information. Receives: Other: Online, patient-facing decision-making aid (app) with personalized risk information.; Device: Implantable Cardioverter Defibrillator (ICD) |
| Use of a digital decision-making app without personalized risk information. | Experimental | The participant will use the pre-visit, participant-facing app without personal risk information. During a clinical encounter, the clinician will have access to an abbreviated clinician-facing digital tool. Receives: Device: Implantable Cardioverter Defibrillator (ICD); Other: Online, patient-facing decision-making app without personalized risk information. |
| Usual clinical care | Placebo comparator | Participant will receive usual clinical care without use of the digital decision-making app. Receives: Device: Implantable Cardioverter Defibrillator (ICD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional Conflict Scale (DCS)
The Decisional Conflict Scale is a validated, 16-item questionnaire scale assessing whether a participant feels conflicted regarding a past medical decision. The range is 0 to 100 with higher scores indicating more conflict, a negative outcome.
Measured: Immediately after decision-making visit as well as at 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start1 Aug 2025
- Primary completionAug 2026 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure and Reduced Ejection FractionStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-arm randomized, parallel clinical trial. Arm A: digital decision-making tool with personalized risk information, Arm B: digital decision-making tool without personalized risk information, and Arm C: usual clinical care without digital tool use.
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of California, San Francisco, East Carolina University
- Responsible party
- Principal investigator, Randall Stafford, Stanford University
- Investigators
- Randall S Stafford, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07084142
- Sponsor's protocol ID
- IRB-79108
- Other IDs
- R01HL173578
- Status last verified
- Apr 2026
- First submitted
- 16 Jul 2025
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Upon reasonable request after January 1, 2027, IPD will be provided without cost.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing "A Digital Shared Decision-Making Aid to Improve Patient-Centered Outcomes in Implantable Cardioverter-Defibrillator (ICD) Decisions Among Older Patients"
- ClinicalTrials.gov ID
- NCT07084142
- Acronym / sponsor ID
- IRB-79108
- Keywords
- heart failure, HFrEF, sudden cardiac death, patient education, shared decision-making, arrhythmia, implantable cardioverter-defibrillator
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of California, San Francisco, East Carolina University
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 24 Jul 2025 (actual)
- 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.
Advanced heart failure, affecting 7 million Americans, has multiple causes and results in greatly increased risk of disability and death. A major problem is sudden cardiac death, when the damaged heart develops an abnormal pattern of electrical conduction that can result in cessation of heart activity. While placement of an Implantable Cardioverter-Defibrillator (ICD) in a patient's chest can help prevent sudden cardiac death, these devices have several important downsides. This protocol focuses on development of a digital decision aid that helps heart failure patients make informed decisions that balance the benefits and downsides of ICD placement. This protocol covers the use of participant surveys, focus groups, and interviews to obtain the needed background information to guide the development of this digital tool, which will be subsequently tested against usual care in a randomized clinical trial. The study design is best described as a mixed methods evaluation and refinement of a digital app to improve ICD decision-making. In the future, the present protocol will be modified to create a new protocol that covers the needed human subjects requirements for performance of this clinical trial.
Detailed description
Advanced heart failure, affecting 7 million Americans, has multiple causes and results in greatly increased risk of disability and death. A major problem is sudden cardiac death, when the damaged heart develops an abnormal pattern of electrical conduction that can result in cessation of heart activity. While placement of an Implantable Cardioverter-Defibrillator (ICD) in a patient's chest can help prevent sudden cardiac death, these devices have several important downsides. This protocol focuses on development of a digital decision aid that helps heart failure patients make informed decisions that balance the benefits and downsides of ICD placement. This protocol covers the use of participant surveys, focus groups, and interviews to obtain the needed background information to guide the development of this digital tool, which will be subsequently tested against usual care in a randomized clinical trial. In the future, the present protocol will be modified to create a new protocol that covers the needed human subjects requirements for performance of this clinical trial.
Participants with heart failure who agree to participate will be recorded in a REDCap system database. The investigators will document in a recruitment tracking log all potentially eligible participants found to be ineligible or who decline participation. The reason for ineligibility or reason for decline will be captured along with age, gender, and race/ethnicity. At the time of their enrollment, the investigators will collect additional information from each participant about their employment status (full-time or part-time employment, no employment, retired), education (no postsecondary education, some postsecondary education), household size (living alone, living with at least one other person).
Participants with heart failure will be asked if they are willing to be interviewed, participate in focus groups, or complete surveys to determine their views on 1) which elements of patient outcome questionnaires are important to them; 2) which decision aid components or educational tools they like or find valuable. Interactions with participants will include open-ended interviews, focus groups, and surveys. These interviews, focus groups, and surveys will be conducted by study staff to help develop a patient-centric shared decision making software tool. Development will occur iteratively with new testing after any modifications. The same individuals may be asked to re-test the app following alterations.
Collaborating teams from UC San Francisco (Site PI: Daniel Morin, MD, MPH) and East Carolina University (Site PI: Samuel Sears, PhD) will join the study before the third month of operation. The participation of these clinical sites is not needed in the first steps on digital tool development. By successfully initiating the project at Stanford, the process of initiation at the clinical sites will be facilitated and is consistent with the mandated use of a single IRB for the three sites.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three-arm randomized, parallel clinical trial. Arm A: digital decision-making tool with personalized risk information, Arm B: digital decision-making tool without personalized risk information, and Arm C: usual clinical care without digital tool use.
| Arm | Type | Receives |
|---|---|---|
| Exposure to digital decision-making app with personal risk information | Experimental | Other: Online, patient-facing decision-making aid (app) with personalized risk information., Device: Implantable Cardioverter Defibrillator (ICD)The participant will use the pre-visit, participant-facing app with personal risk information derived from participant characteristics. During a clinical encounter, the clinician will have access to an abbreviated clinician-facing digital tool that displays the same personalized information. |
| Use of a digital decision-making app without personalized risk information. | Experimental | Device: Implantable Cardioverter Defibrillator (ICD), Other: Online, patient-facing decision-making app without personalized risk information.The participant will use the pre-visit, participant-facing app without personal risk information. During a clinical encounter, the clinician will have access to an abbreviated clinician-facing digital tool. |
| Usual clinical care | Placebo comparator | Device: Implantable Cardioverter Defibrillator (ICD)Participant will receive usual clinical care without use of the digital decision-making app. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Meets or approximates minimal criteria for primary prevention ICD placement. ● Left Ventricular Ejection Fraction (LVEF) <35%.
- Clinical diagnosis of Heart Failure:
- Patients with severe ischemic dilated cardiomyopathy and underlying NYHA
- Class II or III Heart Failure, OR, Patients with severe nonischemic dilated cardiomyopathy and underlying NYHA Class II or III Heart Failure.
- Age ≥ 70 years old.
Key exclusion criteria (11 listed)
- Past ICD implantation (not including pacemakers).
- Any indication for secondary prevention of SCD via ICD implantation.
- History of mechanical valve replacement.
- History of recent myocardial infarction within the last 40 days.
- History of recent revascularization within the past 90 days.
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 |
|---|---|---|
| Online, patient-facing decision-making aid (app) with personalized risk information.The online, patient-facing decision-making aid will have the following features: 1. Clinical Data Input, 2. Introduction via Animated Video, 3. Common Questions, 4. Check-In Quiz, 5. Risk and Values Exploration based on patient specific information, 6. Wrap-Up, 7. Patient-Physician Worksheet, These steps will be completed by the patient in advance of a provider visit where a shared-decision making process will decide whether an ICD is an appropriate sudden cardiac death-prevention strategy to pursue. | Other | Exposure to digital decision-making app with personal risk information |
| Implantable Cardioverter Defibrillator (ICD)Some participants, in their course of medical care unrelated to the study intervention, will undergo implantation of an ICD. | Device | Exposure to digital decision-making app with personal risk information, Use of a digital decision-making app without personalized risk information., Usual clinical care |
| Online, patient-facing decision-making app without personalized risk information.The online, patient-facing decision-making aid will have the following features: 1) Clinical Data Input, 2) Introduction via Animated Video, 3) Common Questions, 4) Check-In Quiz, 5) Generic Risk and Values Exploration without patient specific information, 6) Wrap-Up, 7) Patient-Physician Worksheet, These steps will be completed by the patient in advance of a provider visit where a shared-decision making process will decide whether an ICD is an appropriate sudden cardiac death-prevention strategy to pursue. | Other | Use of a digital decision-making app without personalized risk information. |
Primary outcome
Decisional Conflict Scale (DCS)
Time frame: Immediately after decision-making visit as well as at 3 months.
The Decisional Conflict Scale is a validated, 16-item questionnaire scale assessing whether a participant feels conflicted regarding a past medical decision. The range is 0 to 100 with higher scores indicating more conflict, a negative outcome.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: Yes. Upon reasonable request after January 1, 2027, IPD will be provided without cost.
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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.
Darlyne Esparza contact
Randall S Stafford, MD, PhD principal investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online, patient-facing decision-making aid (app) with personalized risk information., Implantable Cardioverter Defibrillator (ICD) and Online, patient-facing decision-making app without personalized risk information. in people with Heart Failure and Reduced Ejection Fraction, run by Stanford University at 2 sites 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 6 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Randall S Stafford, MD, PhD, MHS (650-724-2400, rstafford@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decisional Conflict Scale (DCS) (time frame: Immediately after decision-making visit as well as at 3 months.). 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 27 Apr 2026.