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Trial Outcomes & Findings for Removing Surrogates' Uncertainty to Reduce Fear and Anxiety After Cardiac Events (NCT NCT06048068)

NCT ID: NCT06048068

Last Updated: 2025-11-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

53 participants

Primary outcome timeframe

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

Results posted on

2025-11-18

Participant Flow

Participant milestones

Participant milestones
Measure
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. 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.
Control Arm
Participants in this arm will receive usual care and no access to the informational intervention program.
Overall Study
STARTED
36
17
Overall Study
COMPLETED
21
11
Overall Study
NOT COMPLETED
15
6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Removing Surrogates' Uncertainty to Reduce Fear and Anxiety After Cardiac Events

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Informational Intervention Arm
n=36 Participants
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. 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.
Control Arm
n=17 Participants
Participants in this arm will receive usual care and no access to the informational intervention program.
Total
n=53 Participants
Total of all reporting groups
Race (NIH/OMB)
White
20 Participants
n=202 Participants
10 Participants
n=283 Participants
30 Participants
n=120 Participants
Age, Categorical
<=18 years
0 Participants
n=202 Participants
0 Participants
n=283 Participants
0 Participants
n=120 Participants
Age, Categorical
Between 18 and 65 years
30 Participants
n=202 Participants
15 Participants
n=283 Participants
45 Participants
n=120 Participants
Age, Categorical
>=65 years
6 Participants
n=202 Participants
2 Participants
n=283 Participants
8 Participants
n=120 Participants
Age, Continuous
48.2 years
STANDARD_DEVIATION 16.0 • n=202 Participants
48.0 years
STANDARD_DEVIATION 12.6 • n=283 Participants
48.2 years
STANDARD_DEVIATION 14.9 • n=120 Participants
Sex: Female, Male
Female
26 Participants
n=202 Participants
12 Participants
n=283 Participants
38 Participants
n=120 Participants
Sex: Female, Male
Male
10 Participants
n=202 Participants
5 Participants
n=283 Participants
15 Participants
n=120 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
8 Participants
n=202 Participants
4 Participants
n=283 Participants
12 Participants
n=120 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
28 Participants
n=202 Participants
12 Participants
n=283 Participants
40 Participants
n=120 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=202 Participants
1 Participants
n=283 Participants
1 Participants
n=120 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=202 Participants
0 Participants
n=283 Participants
1 Participants
n=120 Participants
Race (NIH/OMB)
Asian
1 Participants
n=202 Participants
2 Participants
n=283 Participants
3 Participants
n=120 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=202 Participants
0 Participants
n=283 Participants
0 Participants
n=120 Participants
Race (NIH/OMB)
Black or African American
8 Participants
n=202 Participants
1 Participants
n=283 Participants
9 Participants
n=120 Participants
Race (NIH/OMB)
More than one race
6 Participants
n=202 Participants
2 Participants
n=283 Participants
8 Participants
n=120 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=202 Participants
2 Participants
n=283 Participants
2 Participants
n=120 Participants
Region of Enrollment
United States
36 participants
n=202 Participants
17 participants
n=283 Participants
53 participants
n=120 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Informational Intervention Arm
n=21 Participants
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. 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.
Control Arm
n=11 Participants
Participants in this arm will receive usual care and no access to the informational intervention program.
Mishel Uncertainty in Illness Scale Score - Family Member Form
82.67 score on a scale
Interval 78.31 to 87.02
88.18 score on a scale
Interval 83.04 to 93.32

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Informational Intervention Arm
n=21 Participants
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. 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.
Control Arm
n=11 Participants
Participants in this arm will receive usual care and no access to the informational intervention program.
Post-Traumatic Stress Disorder Checklist (PCL-5) Score
22.1 score on a scale
Standard Deviation 13.3
32.7 score on a scale
Standard Deviation 12.65

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Informational Intervention Arm
n=22 Participants
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. 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.
Control Arm
n=11 Participants
Participants in this arm will receive usual care and no access to the informational intervention program.
Cardiac Anxiety Questionnaire Score - Fear Subscale
18.3 score on a scale
Standard Deviation 3.8
18.9 score on a scale
Standard Deviation 7.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Informational Intervention Arm
n=22 Participants
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. 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.
Control Arm
n=11 Participants
Participants in this arm will receive usual care and no access to the informational intervention program.
Zarit Burden Interview 12-item Short Form Score
12.5 score on a scale
Standard Deviation 6.75
18.6 score on a scale
Standard Deviation 8.3

Adverse Events

Informational Intervention Arm

Serious events: 0 serious events
Other events: 0 other events
Deaths: 11 deaths

Control Arm

Serious events: 0 serious events
Other events: 0 other events
Deaths: 5 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sachin Agarwal, MD MPH

Columbia University Irving Medical Center

Phone: 212-305-7236

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place