Cardiac ArrestCARENCT02275234
Care After Resuscitation
An observational study of Cardiac Arrest, run by Mid and South Essex NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The purpose of this study is to investigate whether simple psychological interventions can be implemented at the Essex Cardiothoracic Centre (CTC) with a view to supporting the psychological wellbeing of survivors of cardiac arrest during their recovery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Psychological intervention
- How many people
- 75 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2014to 31 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: Retrospective and prospective cohort of patients following cardiac arrest
Who may be able to join
- Anyone surviving cardiac arrest
- Age greater than or equal to 18 yrs
- Cerebral Performance Category (CPC) 1-2 at the time of discharge from hospital
- English speaking
- Able to give informed consent
Who cannot join
- Age less than 18yrs
- CPC 3-5 at the time of discharge from hospital
- Non-English speaking
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Essex Cardiothoracic Centre
Basildon, Essex, SS16 5NL
About this study
Official title: A Feasibility Study of Implementing a Simple Psychological Intervention in Survivors of Cardiac Arrest and Their Family Members/Friend to Assess the Impact on Their Quality of Life and Cognitive Function
The purpose of this study is to investigate whether simple psychological interventions can be implemented at the Essex Cardiothoracic Centre (CTC) with a view to supporting the psychological wellbeing of survivors of cardiac arrest during their recovery.
Read the detailed description
At the Essex Cardiothoracic Centre (CTC) the follow up of patients surviving cardiac arrest demonstrated that standard psychological support arrangements for patients and their families/relatives were inadequate.
The purpose of this study is to investigate simple psychological interventions can be implemented here at the Essex CTC with a view to supporting the psychological wellbeing of survivors of cardiac arrest during their recovery.
The investigators propose to recruit 2 groups of patients. The first group will be chosen from patients who have already survived a cardiac arrest > 3 months prior to the start of the study. Participants in this group (patient and a relative/friend) will be invited to attend an outpatient clinic at the Essex CTC with members of the research team. The investigators will record general physical health condition and psychological wellbeing, using recommended questionnaires. A referral to onsite consultant psychiatrist will be offered to anyone expressing signs of severe depression.
The second group will be recruited from patients who survive cardiac arrest from the start of study date. Participants in this group (patient and a relative/friend) will be approached by a member of the research team whilst in hospital and an informed consent will be obtained. Baseline data will be acquired using the recommended questionnaires and a supportive psychological intervention will be offered in the form of a dedicated telephone helpline, attendance at a cardiac arrest clinic and early referral to clinical psychiatrist if appropriate for psychological help. At around 6 months from the date of cardiac arrest, participants will be invited to attend a clinic to reevaluate post cardiac arrest care using the same recommended questionnaires. At the end of the study, the data between the 2 groups will be analysed.
- Conditions
- Cardiac Arrest
- Being tested
- Psychological intervention
- Keywords
- cardiac arrest, psychological intervention
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological interventionOther
Psychological support via clinic visit, helpline and telephone calls
| Study group | Role | What they receive |
|---|---|---|
| Retrospective | Patients who survived cardiac arrest >3 months prior to the start of the study and a close family/friend,will be invited to attend an outpatient clinic | |
| Prospective- psychological intervention | In patients who survived cardiac arrest and a close family/friend,will be invited to attend an outpatient clinic Receives: Other: Psychological intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Life as measured by responses on SF36
Change in Quality of Life before and after psychological intervention in patients surviving cardiac arrest and their family/friends
Measured: 6 months
Change in cognitive function as measured by responses on Montreal Cognitive function tool
Change in cognitive function before and after psychological intervention in patients surviving cardiac arrest and their family/friends
Measured: 6 months
Change in cognitive function as measured by responses on Cogfail questionnaire
Change in cognitive function before and after psychological intervention in patients surviving cardiac arrest and their family/friends
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2014 (estimated)
- Study startSep 2014
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mid and South Essex NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Anglia Ruskin University
- Responsible party
- Sponsor
- Investigators
- Thomas R Keeble, MBBS MD MRCP, Principal investigator, Basildon and Thurrock University Hospitals NHS FT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02275234
- Sponsor's protocol ID
- B709
- Acronym
- CARE
- Status last verified
- Aug 2021
- First submitted
- 17 Oct 2014
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Implementing a Simple Psychological Intervention in Survivors of Cardiac Arrest and Their Family Members/Friend to Assess the Impact on Their Quality of Life and Cognitive Function
- ClinicalTrials.gov ID
- NCT02275234
- Acronym / sponsor ID
- CARE / B709
- Conditions
- Cardiac Arrest
- Keywords
- cardiac arrest, psychological intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Mid and South Essex NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Anglia Ruskin University
- Study start
- Sep 2014 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 27 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate whether simple psychological interventions can be implemented at the Essex Cardiothoracic Centre (CTC) with a view to supporting the psychological wellbeing of survivors of cardiac arrest during their recovery.
Detailed description
At the Essex Cardiothoracic Centre (CTC) the follow up of patients surviving cardiac arrest demonstrated that standard psychological support arrangements for patients and their families/relatives were inadequate.
The purpose of this study is to investigate simple psychological interventions can be implemented here at the Essex CTC with a view to supporting the psychological wellbeing of survivors of cardiac arrest during their recovery.
The investigators propose to recruit 2 groups of patients. The first group will be chosen from patients who have already survived a cardiac arrest > 3 months prior to the start of the study. Participants in this group (patient and a relative/friend) will be invited to attend an outpatient clinic at the Essex CTC with members of the research team. The investigators will record general physical health condition and psychological wellbeing, using recommended questionnaires. A referral to onsite consultant psychiatrist will be offered to anyone expressing signs of severe depression.
The second group will be recruited from patients who survive cardiac arrest from the start of study date. Participants in this group (patient and a relative/friend) will be approached by a member of the research team whilst in hospital and an informed consent will be obtained. Baseline data will be acquired using the recommended questionnaires and a supportive psychological intervention will be offered in the form of a dedicated telephone helpline, attendance at a cardiac arrest clinic and early referral to clinical psychiatrist if appropriate for psychological help. At around 6 months from the date of cardiac arrest, participants will be invited to attend a clinic to reevaluate post cardiac arrest care using the same recommended questionnaires. At the end of the study, the data between the 2 groups will be analysed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective | – | –Patients who survived cardiac arrest >3 months prior to the start of the study and a close family/friend,will be invited to attend an outpatient clinic |
| Prospective- psychological intervention | – | Other: Psychological interventionIn patients who survived cardiac arrest and a close family/friend,will be invited to attend an outpatient clinic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospective and prospective cohort of patients following cardiac arrest
Key inclusion criteria (5 listed)
- Anyone surviving cardiac arrest
- Age greater than or equal to 18 yrs
- Cerebral Performance Category (CPC) 1-2 at the time of discharge from hospital
- English speaking
- Able to give informed consent
Key exclusion criteria (4 listed)
- Age less than 18yrs
- CPC 3-5 at the time of discharge from hospital
- Non-English speaking
- Unable to give informed consent
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 |
|---|---|---|
| Psychological interventionPsychological support via clinic visit, helpline and telephone calls | Other | Prospective- psychological intervention |
Primary outcome
Change in Quality of Life as measured by responses on SF36
Time frame: 6 months
Change in Quality of Life before and after psychological intervention in patients surviving cardiac arrest and their family/friends
Change in cognitive function as measured by responses on Montreal Cognitive function tool
Time frame: 6 months
Change in cognitive function before and after psychological intervention in patients surviving cardiac arrest and their family/friends
Change in cognitive function as measured by responses on Cogfail questionnaire
Time frame: 6 months
Change in cognitive function before and after psychological intervention in patients surviving cardiac arrest and their family/friends
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Thomas R Keeble, MBBS MD MRCP principal investigator
Basildon and Thurrock University Hospitals NHS FT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest, run by Mid and South Essex NHS Foundation Trust at 1 site in United Kingdom.
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 4 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 8 Sep 2021. 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 Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Quality of Life as measured by responses on SF36 (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2021.