Removing Surrogates' Uncertainty to Reduce Fear and Anxiety After Cardiac Events
NCT ID: NCT06048068
Last Updated: 2025-11-18
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
53 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-09-07
Study Completion Date
2024-10-14
Brief Summary
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The goal of this study is to test the feasibility and acceptability of an informational website to reduce uncertainty, psychological distress, and caregiver burden among close family members of cardiac arrest patients. The investigators hypothesize that participants who receive access to the website will have lower rates of uncertainty, psychological distress, and caregiver burden at 3 months post-hospital discharge compared to participants who receive usual care.
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Detailed Description
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This study will be an unblinded, two-arm randomized controlled trial that enrolls up to 100 adult surrogates of living cardiac arrest patients hospitalized in the New York Presbyterian hospital system. Participants must be English- or Spanish-speaking and have a device with internet access. Participants will be randomized 2:1 to receive the informational intervention program or usual care (control).
Intervention arm participants will receive the informational intervention in three discrete packages upon study enrollment, movement to the general medical floor, and at one month post-discharge. All participants will be assessed at study enrollment, hospital discharge, and 3 months post-discharge for their illness uncertainty, psychological distress, and caregiver burden. All participants will also wear a GENEActiv sleep monitor to track their sleep for one week following hospital discharge.
Intervention arm participants will receive the informational intervention in three discrete packages upon study enrollment, movement to the general medical floor, and at one month post-discharge. All participants will be assessed at study enrollment, hospital discharge, and 3 months post-discharge for their illness uncertainty, psychological distress, and caregiver burden. All participants will also wear a GENEActiv sleep monitor to track their sleep for one week following hospital discharge.
Conditions
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Cardiac Arrest
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Participants will be randomized 2:1 to the informational intervention group or the control group (care as usual). Participants will remain in their assigned arm for the entirety of their study participation. Randomization will be performed using the REDCap randomization module by a study coordinator. This study will be unblinded.
Primary Study Purpose
PREVENTION
Blinding Strategy
NONE
Study Groups
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Informational Intervention Arm
Participants in this arm will receive access to the informational intervention program, via a website link that they will access through their own person phone/tablet/computer.
Group Type
EXPERIMENTAL
Educational Informational Platform
Intervention Type
BEHAVIORAL
This intervention contains many informational articles for surrogates about cardiac arrest, the subsequent hospitalization, and the emotional journey following cardiac arrest. All articles are available in both English and Spanish.
Control Arm
Participants in this arm will receive usual care and no access to the informational intervention program.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Educational Informational Platform
This intervention contains many informational articles for surrogates about cardiac arrest, the subsequent hospitalization, and the emotional journey following cardiac arrest. All articles are available in both English and Spanish.
Intervention Type
BEHAVIORAL
Other Intervention Names
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Heartsight website, ourheartsight.com
Eligibility Criteria
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Inclusion Criteria
* 18 years of age or older
* Surrogate of a living NewYork Presbyterian Hospital cardiac arrest patient
* English- or Spanish-speaking
* Has a working smartphone, tablet, laptop, or other device with internet access
* Surrogate of a living NewYork Presbyterian Hospital cardiac arrest patient
* English- or Spanish-speaking
* Has a working smartphone, tablet, laptop, or other device with internet access
Exclusion Criteria
* Any medical and/or psychiatric impairment precluding them from complying with the protocol
* Non-English and non-Spanish speaking
* Lack of internet/device access
* Surrogate of an adult CA patient who passed away
* Cannot be reached for initial contact (3 unsuccessful attempts made in ICU)
* Moved to the in-patient floor before initial contact can be established
* Non-English and non-Spanish speaking
* Lack of internet/device access
* Surrogate of an adult CA patient who passed away
* Cannot be reached for initial contact (3 unsuccessful attempts made in ICU)
* Moved to the in-patient floor before initial contact can be established
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Institute on Aging (NIA)
NIH
Sponsor Role
collaborator
Columbia University
OTHER
Sponsor Role
lead
Responsible Party
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Sachin Agarwal
Associate Professor of Neurology (Neurocritical Care)
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Sachin Agarwal, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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Columbia University Medical Center/New York Presbyterian
New York, New York, United States
Site Status
Countries
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United States
References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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AAAR8497
Identifier Type: -
Identifier Source: org_study_id
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NA
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COMPLETED
Remediation for Mild Cognitive Deficits After Cancer
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UNKNOWN
NA
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ACTIVE_NOT_RECRUITING
NA
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COMPLETED
NA
MIND Foods and Aerobic Training in Black Adults With HTN
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RECRUITING
NA
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COMPLETED
NA
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ACTIVE_NOT_RECRUITING
NA