RECRUITING

Developing a Digital Aid to Improve ICD Decisions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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. 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.

Official Title

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

Quick Facts

Study Start:2025-07
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07084142

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Randall S Stafford, MD, PhD, MHS
CONTACT
650-724-2400
rstafford@stanford.edu
Darlyne Esparza
CONTACT
desparza@stanford.edu

Principal Investigator

Randall S Stafford, MD, PhD
PRINCIPAL_INVESTIGATOR
Stanford University

Study Locations (Sites)

University of California, San Francisco
San Francisco, California, 94143
United States
Eastern Carolina University
Greenville, North Carolina, 27858
United States

Collaborators and Investigators

Sponsor: Stanford University

  • Randall S Stafford, MD, PhD, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07
Study Completion Date2026-06

Study Record Updates

Study Start Date2025-07
Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

  • heart failure
  • HFrEF
  • sudden cardiac death
  • patient education
  • shared decision-making
  • arrhythmia
  • implantable cardioverter-defibrillator

Additional Relevant MeSH Terms

  • Heart Failure and Reduced Ejection Fraction