Cardiac ArrestFAID FearNCT05144477
Family-Authored ICU Diaries to Reduce Fear in Patients Experiencing a Cardiac Arrest (FAID Fear)
A study testing FAID Fear Intervention in people with Cardiac Arrest and Post Traumatic Stress Syndrome, run by Columbia University at 1 site in United States.
Trial summary
The present study will: Aim 1: Enroll 15 family members of CA patients to (a) pilot recruitment procedures, (b) estimate retention, and (c) assess acceptability of study procedures. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrest, Post Traumatic Stress Syndrome
- What is being tested?
- FAID Fear Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2021to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The family member of a patient who has experienced a cardiac arrest
- Age 18 years and over
- Able to speak, read, and write in English or Spanish
- Participating in the CANOE study (AAAR8497) and indicated they were willing to hear about future research opportunities
- Willing to write in a journal about their experiences
Who cannot join
- Unavailable for follow-up
- Medical or psychiatric impairment that would prevent them from complying with the research protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Family-Authored ICU Diaries to Reduce Fear in Patients Experiencing a Cardiac Arrest (FAID Fear): A Pilot Intervention Study
The present study will:
Aim 1: Enroll 15 family members of CA patients to (a) pilot recruitment procedures, (b) estimate retention, and (c) assess acceptability of study procedures.
Read more
Family members will be randomized to either complete an ICU diary or to a control condition, and will complete surveys in the ICU, at patient discharge, and 30 days post-discharge.
Aim 2: Obtain an estimate of the association of intervention v. control with (i) family member fear (operationalized as cardiac anxiety about the patients' cardiac condition) at hospital discharge and (ii) family member PTSS 30 days post-discharge.
Exploratory Aims: Obtain an estimate of the association of intervention v. control with family member aversive cognitions towards exercise at hospital discharge.
Read the detailed description
A cardiac arrest (CA) is a terrifying experience for patients, but maybe even more so for their loved ones. CA patients often have little to no memory of the CA and are often unconscious for substantial parts of their hospitalization, particularly their time in the intensive care unit (ICU) . In contrast, family members often witness all of these things, resulting in high levels of fear and psychological distress in family members. This phenomenon is so prevalent that it has been termed Post-Intensive Care Syndrome - Family (PICS - Family).
Critically, emotions are socially transmitted and memories are socially constructed. In this manner, family members can transmit their distress onto patients. Prior research has suggested that patients experiencing CA will develop memories of the CA event over time - potentially because they are trying to "fill in the gaps" in their memory. As such, family members may play a critical role in creating and cementing fear-based memories and distress in patients experiencing a CA. CA patients often report cardiac fear and preoccupation. This is not without consequence: fear-based distress, particularly early anxiety related to symptoms (e.g., rapid heartbeat) and markers for PTSS in other patient populations predicts reduced engagement in behavior necessary for secondary prevention (e.g., reduced physical activity) and increased morbidity and mortality. Distress in family members can also have an adverse impact on patients by undermining the capacity of family members to provide effective social support that can buffer patient distress.
A prior clinical trial found that family-authored diaries significantly reduced PTSS in family members (26.3% lower in intervention v. control conditions, 95% CI 4.8, 52.2) and trended towards a reduction in PTSS for patients (11.2% lower, 95% CI 15.7, 46.8). However, mechanisms of these effects were not examined, and no dyadic effects were tested. Furthermore, these previous diary studies have been conducted with the intention of sharing diaries with patients.
The present study will test the feasibility involving a similar Family-Authored ICU-diary intervention to reduce a proximal, dyadic mechanism: fear of CA in patients' family members. The target audience of the diary is thus family members, and patients will not see the diary unless the family member individually chooses to share it. The feasibility of targeting family member well-being alone is untested. The long-term goal is conducting a large scale randomized clinical trial (RCT) that tests whether a family-authored ICU diary can reduce fear of cardiac arrest in family members, and in turn, improve patients' mental wellbeing, health behaviors, and, ultimately, health outcomes.
- Conditions
- Cardiac Arrest, Post Traumatic Stress Syndrome
- Being tested
- FAID Fear Intervention
- Keywords
- Family Members, Couples, Partners, Fear, Fear of Exercise, Physical Activity
- Medical subject headings
- Heart Arrest, Combat Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAID Fear InterventionBehavioural
Also called Family-Authored ICU Diaries to Reduce Fear
Participants will receive a hard-cover diary, written instructions on diary completion, and a pen. A trained research assistant will meet with the participant face to face or via telephone and explain how to use the diary. Instructions will include recommended frequency for writing (at least twice a week) and tips on how to express themselves. Potential topics will also be addressed, including what to write about in the beginning, during the ICU, and after ICU discharge. The hard copy of the diary will remain with the family member participant, and they will be asked to continue writing in the diary at least until patient discharge from the hospital. Research assistants will check in with participants via weekly telephone calls to provide prompts to remind them to use the diary and support, as needed, if the participant reports difficulty in writing diary entries. These calls will last approximately 1-5 minutes and will continue until patient discharge from the hospital.
| Study group | Role | What they receive |
|---|---|---|
| FAID Fear Intervention | Experimental | Family members of CA patients assigned to intervention will receive the ICU diary. Receives: Behavioral: FAID Fear Intervention |
| Control condition - Usual Care | No intervention | Family members of CA patients assigned to usual care will not receive the ICU diary. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Eligible Family Members of Cardiac Arrest (CA) Patients Who Agree/Consent to Participate in the Pilot Study
This is to assess feasibility of recruitment. Potential family member participants whom the study team approaches and agree/consent to take part in the study will be tallied.
Specifically, we divided the number of family member participants who enrolled in the study by the number of potential participants referred to the study (enrolled/referred).
Measured: Baseline (ICU admittance)
Proportion of Enrolled Family Members Who Complete the Pilot Study
This is to estimate/assess retention. Family members who remain in the study at the final assessment will be tallied.
Specifically, we divided the number of family member participants who completed the study by the number of potential participants who did not complete the study (completed/did not complete).
Measured: 30 days post-discharge
Secondary outcomes (5)
Proportion of Family Members That Adhere to the Diary Intervention
This is to assess acceptability of study procedures. Family members who report completing at least 2 diary entries/week will be tallied.
Specifically, we divided the number of family member participants in the diary intervention who adhered to the intervention by the number of participants who did not adhere to the intervention (adhered/did not adhere).
Measured: Up to hospital discharge (approximately 21 days)
Proportion of Family Members That Complete the Majority of Survey Assessments
This is to assess acceptability of study procedures. Family members who complete at least 90% of survey assessments will be tallied.
Specifically, we divided the number of family member participants who completed at least 90% of survey assessments by the number of family member participants who completed less than 90% of survey assessments (completed/did not complete).
Measured: Up to 30 days post-discharge
Proportion of Family Members That Agree That the Intervention Was Acceptable
As a measure of intervention acceptability, study will assess the proportion of participants who agree that the intervention was acceptable for reducing cardiac anxiety about the patient's heart using mean of the 4-item Acceptability of Intervention Measure (score >= 4; 1 = completely disagree, 5 = completely agree). Possible mean scores range from 1 to 5.
Specifically, we divided the number of family member participants in the diary intervention who agreed the intervention was acceptable by the number of family member participants in the diary intervention who did not agree that the intervention was acceptable (acceptable/not acceptable).
Measured: 30 days post-discharge
Proportion of Family Members That Agree That the Intervention Was Feasible
As a measure of intervention acceptability, study will assess the proportion of participants who agree that the study was feasible using the mean of the 4-item Feasibility of Intervention Measure (score >= 4; 1 = completely disagree, 5 = completely agree). Possible mean scores range from 1 to 5.
Specifically, we divided the number of family member participants in the diary intervention who agreed the intervention was feasible by the number of family member participants in the diary intervention who did not agree that the intervention was feasible (feasible/not feasible).
Measured: 30 days post-discharge
Proportion of Family Members That Agree That the Intervention Was Appropriate
As a measure of intervention acceptability, study will assess the proportion of participants who agree that the study was appropriate for reducing cardiac anxiety about the patient's heart using the 4-item Intervention Appropriateness Measure (score >= 4; 1 = completely disagree, 5 = completely agree). Possible mean scores range from 1 to 5.
Specifically, we divided the number of family member participants in the diary intervention who agreed the intervention was appropriate by the number of family member participants in the diary intervention who did not agree that the intervention was appropriate (appropriate/not appropriate).
Measured: 30 days post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start29 Nov 2021
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Talea M. Cornelius, Columbia University
- Investigators
- Talea Cornelius, PhD, MSW, MS, Principal investigator, Assistant Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05144477
- Sponsor's protocol ID
- AAAT7681
- Other IDs
- P30AG064198
- Acronym
- FAID Fear
- Status last verified
- Apr 2023
- First submitted
- 22 Nov 2021
- Last updated
- 28 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Explicit permission from participants to post de-identified data online was not obtained; rather, participants consented that, "Upon removal of identifiers from the dataset, data may be shared with other researchers." In accordance with recommendations for sharing raw clinical data for publication stating that it is ideal to obtain this consent, data are available only by request from the study PI. Hrynaszkiewicz I, Norton ML, Vickers AJ, Altman DG. Preparing raw clinical data for publication: guidance for journal editors, authors, and peer reviewers. Bmj. 2010;340.
Publications
Davidson JE, Jones C, Bienvenu OJ. Family response to critical illness: postintensive care syndrome-family. Crit Care Med. 2012 Feb;40(2):618-24. doi: 10.1097/CCM.0b013e318236ebf9.
PubMed 22080636Gump BB, Kulik JA. Stress, affiliation, and emotional contagion. J Pers Soc Psychol. 1997 Feb;72(2):305-19. doi: 10.1037//0022-3514.72.2.305.
PubMed 9107002Rossignac-Milon M, Higgins ET. Epistemic companions: shared reality development in close relationships. Curr Opin Psychol. 2018 Oct;23:66-71. doi: 10.1016/j.copsyc.2018.01.001. Epub 2018 Jan 11.
PubMed 29360060French CC. Dying to know the truth: visions of a dying brain, or false memories? Lancet. 2001 Dec 15;358(9298):2010-1. doi: 10.1016/S0140-6736(01)07133-1. No abstract available.
PubMed 11755600Rosman L, Whited A, Lampert R, Mosesso VN, Lawless C, Sears SF. Cardiac anxiety after sudden cardiac arrest: Severity, predictors and clinical implications. Int J Cardiol. 2015 Feb 15;181:73-6. doi: 10.1016/j.ijcard.2014.11.115. Epub 2014 Nov 18.
PubMed 25482282Edmondson D, Richardson S, Falzon L, Davidson KW, Mills MA, Neria Y. Posttraumatic stress disorder prevalence and risk of recurrence in acute coronary syndrome patients: a meta-analytic review. PLoS One. 2012;7(6):e38915. doi: 10.1371/journal.pone.0038915. Epub 2012 Jun 20.
PubMed 22745687Monane R, Sanchez GJ, Kronish IM, Edmondson D, Diaz KM. Post-traumatic stress disorder symptoms and aversive cognitions regarding physical activity in patients evaluated for acute coronary syndrome. Eur J Prev Cardiol. 2018 Mar;25(4):402-403. doi: 10.1177/2047487317746255. Epub 2017 Dec 4. No abstract available.
PubMed 29198138Rafaeli E, Gleason ME. Skilled support within intimate relationships. Journal of Family Theory & Review. 2009;1(1):20-37.
Nielsen AH, Angel S, Egerod I, Hansen TB. The effect of diaries written by relatives for intensive care patients on posttraumatic stress (DRIP study): protocol for a randomized controlled trial and mixed methods study. BMC Nurs. 2018 Aug 16;17:37. doi: 10.1186/s12912-018-0306-y. eCollection 2018.
PubMed 30127664Nielsen AH, Angel S, Egerod I, Lund TH, Renberg M, Hansen TB. The effect of family-authored diaries on posttraumatic stress disorder in intensive care unit patients and their relatives: A randomised controlled trial (DRIP-study). Aust Crit Care. 2020 Mar;33(2):123-129. doi: 10.1016/j.aucc.2019.01.004. Epub 2019 Feb 20.
PubMed 30795978
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-Authored ICU Diaries to Reduce Fear in Patients Experiencing a Cardiac Arrest (FAID Fear): A Pilot Intervention Study
- ClinicalTrials.gov ID
- NCT05144477
- Acronym / sponsor ID
- FAID Fear / AAAT7681
- Conditions
- Cardiac Arrest, Post Traumatic Stress Syndrome
- Keywords
- Family Members, Couples, Partners, Fear, Fear of Exercise, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 3 Dec 2021 (actual)
- Results
- Posted 28 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study will:
Aim 1: Enroll 15 family members of CA patients to (a) pilot recruitment procedures, (b) estimate retention, and (c) assess acceptability of study procedures.
Family members will be randomized to either complete an ICU diary or to a control condition, and will complete surveys in the ICU, at patient discharge, and 30 days post-discharge.
Aim 2: Obtain an estimate of the association of intervention v. control with (i) family member fear (operationalized as cardiac anxiety about the patients' cardiac condition) at hospital discharge and (ii) family member PTSS 30 days post-discharge.
Exploratory Aims: Obtain an estimate of the association of intervention v. control with family member aversive cognitions towards exercise at hospital discharge.
Detailed description
A cardiac arrest (CA) is a terrifying experience for patients, but maybe even more so for their loved ones. CA patients often have little to no memory of the CA and are often unconscious for substantial parts of their hospitalization, particularly their time in the intensive care unit (ICU) . In contrast, family members often witness all of these things, resulting in high levels of fear and psychological distress in family members. This phenomenon is so prevalent that it has been termed Post-Intensive Care Syndrome - Family (PICS - Family).
Critically, emotions are socially transmitted and memories are socially constructed. In this manner, family members can transmit their distress onto patients. Prior research has suggested that patients experiencing CA will develop memories of the CA event over time - potentially because they are trying to "fill in the gaps" in their memory. As such, family members may play a critical role in creating and cementing fear-based memories and distress in patients experiencing a CA. CA patients often report cardiac fear and preoccupation. This is not without consequence: fear-based distress, particularly early anxiety related to symptoms (e.g., rapid heartbeat) and markers for PTSS in other patient populations predicts reduced engagement in behavior necessary for secondary prevention (e.g., reduced physical activity) and increased morbidity and mortality. Distress in family members can also have an adverse impact on patients by undermining the capacity of family members to provide effective social support that can buffer patient distress.
A prior clinical trial found that family-authored diaries significantly reduced PTSS in family members (26.3% lower in intervention v. control conditions, 95% CI 4.8, 52.2) and trended towards a reduction in PTSS for patients (11.2% lower, 95% CI 15.7, 46.8). However, mechanisms of these effects were not examined, and no dyadic effects were tested. Furthermore, these previous diary studies have been conducted with the intention of sharing diaries with patients.
The present study will test the feasibility involving a similar Family-Authored ICU-diary intervention to reduce a proximal, dyadic mechanism: fear of CA in patients' family members. The target audience of the diary is thus family members, and patients will not see the diary unless the family member individually chooses to share it. The feasibility of targeting family member well-being alone is untested. The long-term goal is conducting a large scale randomized clinical trial (RCT) that tests whether a family-authored ICU diary can reduce fear of cardiac arrest in family members, and in turn, improve patients' mental wellbeing, health behaviors, and, ultimately, health outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FAID Fear Intervention | Experimental | Behavioral: FAID Fear InterventionFamily members of CA patients assigned to intervention will receive the ICU diary. |
| Control condition - Usual Care | No intervention | –Family members of CA patients assigned to usual care will not receive the ICU diary. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The family member of a patient who has experienced a cardiac arrest
- Age 18 years and over
- Able to speak, read, and write in English or Spanish
- Participating in the CANOE study (AAAR8497) and indicated they were willing to hear about future research opportunities
- Willing to write in a journal about their experiences
Key exclusion criteria (2 listed)
- Unavailable for follow-up
- Medical or psychiatric impairment that would prevent them from complying with the research protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FAID Fear InterventionAlso: Family-Authored ICU Diaries to Reduce FearParticipants will receive a hard-cover diary, written instructions on diary completion, and a pen. A trained research assistant will meet with the participant face to face or via telephone and explain how to use the diary. Instructions will include recommended frequency for writing (at least twice a week) and tips on how to express themselves. Potential topics will also be addressed, including what to write about in the beginning, during the ICU, and after ICU discharge. The hard copy of the diary will remain with the family member participant, and they will be asked to continue writing in the diary at least until patient discharge from the hospital. Research assistants will check in with participants via weekly telephone calls to provide prompts to remind them to use the diary and support, as needed, if the participant reports difficulty in writing diary entries. These calls will last approximately 1-5 minutes and will continue until patient discharge from the hospital. | Behavioural | FAID Fear Intervention |
Primary outcome
Proportion of Eligible Family Members of Cardiac Arrest (CA) Patients Who Agree/Consent to Participate in the Pilot Study
Time frame: Baseline (ICU admittance)
This is to assess feasibility of recruitment. Potential family member participants whom the study team approaches and agree/consent to take part in the study will be tallied. Specifically, we divided the number of family member participants who enrolled in the study by the number of potential participants referred to the study (enrolled/referred).
Proportion of Enrolled Family Members Who Complete the Pilot Study
Time frame: 30 days post-discharge
This is to estimate/assess retention. Family members who remain in the study at the final assessment will be tallied. Specifically, we divided the number of family member participants who completed the study by the number of potential participants who did not complete the study (completed/did not complete).
5 secondary outcomes
Proportion of Family Members That Adhere to the Diary Intervention
Time frame: Up to hospital discharge (approximately 21 days)
Proportion of Family Members That Complete the Majority of Survey Assessments
Time frame: Up to 30 days post-discharge
Proportion of Family Members That Agree That the Intervention Was Acceptable
Time frame: 30 days post-discharge
Proportion of Family Members That Agree That the Intervention Was Feasible
Time frame: 30 days post-discharge
Proportion of Family Members That Agree That the Intervention Was Appropriate
Time frame: 30 days post-discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22080636Davidson JE, Jones C, Bienvenu OJ. Family response to critical illness: postintensive care syndrome-family. Crit Care Med. 2012 Feb;40(2):618-24. doi: 10.1097/CCM.0b013e318236ebf9.
- Background: PubMed 9107002Gump BB, Kulik JA. Stress, affiliation, and emotional contagion. J Pers Soc Psychol. 1997 Feb;72(2):305-19. doi: 10.1037//0022-3514.72.2.305.
- Background: PubMed 29360060Rossignac-Milon M, Higgins ET. Epistemic companions: shared reality development in close relationships. Curr Opin Psychol. 2018 Oct;23:66-71. doi: 10.1016/j.copsyc.2018.01.001. Epub 2018 Jan 11.
- Background: PubMed 11755600French CC. Dying to know the truth: visions of a dying brain, or false memories? Lancet. 2001 Dec 15;358(9298):2010-1. doi: 10.1016/S0140-6736(01)07133-1. No abstract available.
- Background: PubMed 25482282Rosman L, Whited A, Lampert R, Mosesso VN, Lawless C, Sears SF. Cardiac anxiety after sudden cardiac arrest: Severity, predictors and clinical implications. Int J Cardiol. 2015 Feb 15;181:73-6. doi: 10.1016/j.ijcard.2014.11.115. Epub 2014 Nov 18.
- Background: PubMed 22745687Edmondson D, Richardson S, Falzon L, Davidson KW, Mills MA, Neria Y. Posttraumatic stress disorder prevalence and risk of recurrence in acute coronary syndrome patients: a meta-analytic review. PLoS One. 2012;7(6):e38915. doi: 10.1371/journal.pone.0038915. Epub 2012 Jun 20.
- Background: PubMed 29198138Monane R, Sanchez GJ, Kronish IM, Edmondson D, Diaz KM. Post-traumatic stress disorder symptoms and aversive cognitions regarding physical activity in patients evaluated for acute coronary syndrome. Eur J Prev Cardiol. 2018 Mar;25(4):402-403. doi: 10.1177/2047487317746255. Epub 2017 Dec 4. No abstract available.
- BackgroundRafaeli E, Gleason ME. Skilled support within intimate relationships. Journal of Family Theory & Review. 2009;1(1):20-37.
- Background: PubMed 30127664Nielsen AH, Angel S, Egerod I, Hansen TB. The effect of diaries written by relatives for intensive care patients on posttraumatic stress (DRIP study): protocol for a randomized controlled trial and mixed methods study. BMC Nurs. 2018 Aug 16;17:37. doi: 10.1186/s12912-018-0306-y. eCollection 2018.
- Background: PubMed 30795978Nielsen AH, Angel S, Egerod I, Lund TH, Renberg M, Hansen TB. The effect of family-authored diaries on posttraumatic stress disorder in intensive care unit patients and their relatives: A randomised controlled trial (DRIP-study). Aust Crit Care. 2020 Mar;33(2):123-129. doi: 10.1016/j.aucc.2019.01.004. Epub 2019 Feb 20.
- Individual participant dataSharing planned: No. Explicit permission from participants to post de-identified data online was not obtained; rather, participants consented that, "Upon removal of identifiers from the dataset, data may be shared with other researchers." In accordance with recommendations for sharing raw clinical data for publication stating that it is ideal to obtain this consent, data are available only by request from the study PI. Hrynaszkiewicz I, Norton ML, Vickers AJ, Altman DG. Preparing raw clinical data for publication: guidance for journal editors, authors, and peer reviewers. Bmj. 2010;340.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Talea Cornelius, PhD, MSW, MS principal investigator
Assistant Professor of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FAID Fear Intervention in people with Cardiac Arrest and Post Traumatic Stress Syndrome, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Eligible Family Members of Cardiac Arrest (CA) Patients Who Agree/Consent to Participate in the Pilot Study (time frame: Baseline (ICU admittance)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05144477, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2023.