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Developing a Digital Aid to Improve ICD Decisions

Developing "A Digital Shared Decision-Making Aid to Improve Patient-Centered Outcomes in Implantable Cardioverter-Defibrillator (ICD) Decisions Among Older Patients"

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
60 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires, Interviews

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study uses surveys, group talks, and interviews to help build a digital tool for people with heart failure, mainly those age 70 or older. The tool will help people weigh the benefits and downsides of an ICD, a device placed in the chest to stop dangerous heart rhythms. The study may adjust its entry rules while developing the tool.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Meet or nearly meet the rules for getting an ICD to prevent a first sudden heart death.
  • Have a heart pumping measure called LVEF below 35%.
  • Have heart failure with a severely weakened, enlarged heart, with or without damage from poor blood flow.
  • Have heart failure rated NYHA class II or III, meaning symptoms limit physical activity.
  • Be age 70 or older.
  • Be able to give consent in English, Mandarin, or Spanish and follow study instructions.

Who can't join

  • Have had an ICD before. A pacemaker alone does not exclude you.
  • Need an ICD to prevent another life-threatening heart rhythm event.
  • Have had a mechanical heart valve replacement.
  • Have had a heart attack in the past 40 days or a procedure to restore heart blood flow in the past 90 days.
  • Have an inherited condition with a high risk of dangerous heart rhythms, such as long QT syndrome or hypertrophic cardiomyopathy.
  • Have a medical reason that makes ICD placement unsafe, or be unwilling or unable to consider an ICD.
  • Be expected to live less than 6 months, or have other medical concerns.
  • The final exclusion rule is cut off in the source text and cannot be fully explained.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Developmental Testing will attempt to abide by eligibility criteria identical to the planned criteria for the subsequent RCT, but may strategically deviate from these criteria to enhance the testing and development process. Inclusion Criteria: * 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. Exclusion Criteria: 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. * 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

Study sites (2)

CA

NC