Columbia University Medical Center/New York Presbyterian
New York, 10032, United States
NCT Number: NCT06048068
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
New York, 10032, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Heartsight website, ourheartsight.com
Time frame: Data was collected at study enrollment in the ICU (baseline), at hospital discharge (approximately 21 days after baseline), and 3 months post-hospital discharge. The data at 3 months post-discharge is reported
This metric is a 31-item scale measuring surrogates' self-reported uncertainty related to their loved one's cardiac arrest. Participants will be asked to answer from a scale of 1 to 5, 1 being 'Strongly Disagree' and 5 being 'Strongly Agree.' The scale will be scored out of 155. A higher score indicates a greater level of uncertainty.
Time frame: Data was collected at study enrollment in the ICU (baseline), at hospital discharge (approximately 21 days after baseline), and 3 months post-hospital discharge. The data at 3 months post-discharge is reported
This metric is a 20-item measure of self-reported post-traumatic stress symptoms as defined by the DSM-5. Participants will be asked to score their answer from 0 to 4, 0 being 'Not at all,' and 4 being 'Extremely.' The total score will be out of 80. A higher score indicates more severe PTSD symptoms.
Time frame: Data was collected at hospital discharge (approximately 21 days after baseline) and 3 months post-hospital discharge. The data at 3 months post-discharge is reported
This 8-item metric measures surrogates' self-reported fear of their loved one's cardiac-related stimuli and sensations due to perceived negative consequences. Participants will be asked to rank answers from 1 to 5, 1 being 'Never' and 5 being 'Always.' The total will be out of 40. A higher score indicates more fear and worry related to the heart.
Time frame: At 3 months post-discharge.
This 12-item metric measures surrogates' self-reported caregiver burden. Participants will be asked to score their answers from 0 to 4, 0 being "Never," and 4 being "Always." The total score is taken out of 48. A higher total score indicates a greater degree of caregiver burden.
Columbia University
Other
Removing Surrogates' Uncertainty to Reduce Fear and Anxiety After Cardiac Events (RESURFACE): A Randomized Pilot Intervention Study
Acronym: RESURFACE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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