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Care After Resuscitation (CARE)

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ClinicalTrials.gov Identifier: NCT02275234
Recruitment Status : Completed
First Posted : October 27, 2014
Last Update Posted : January 31, 2018
Sponsor:
Collaborator:
Anglia Ruskin University
Information provided by (Responsible Party):
Basildon and Thurrock University Hospitals NHS Foundation Trust

Brief 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.

Condition or disease Intervention/treatment
Cardiac Arrest Other: Psychological intervention

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.

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Study Type : Observational
Actual Enrollment : 75 participants
Observational Model: Other
Time Perspective: Other
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
Actual Study Start Date : September 2014
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest

Group/Cohort Intervention/treatment
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
Other: Psychological intervention
Psychological support via clinic visit, helpline and telephone calls




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Retrospective and prospective cohort of patients following cardiac arrest
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Age less than 18yrs
  • CPC 3-5 at the time of discharge from hospital
  • Non-English speaking
  • Unable to give informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02275234


Locations
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United Kingdom
Basildon and Thurrock University Hospitals NHS FT
Basildon, Essex, United Kingdom, SS16 5NL
Sponsors and Collaborators
Basildon and Thurrock University Hospitals NHS Foundation Trust
Anglia Ruskin University
Investigators
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Principal Investigator: Thomas R Keeble, MBBS MD MRCP Basildon and Thurrock University Hospitals NHS FT
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Responsible Party: Basildon and Thurrock University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02275234    
Other Study ID Numbers: B709
First Posted: October 27, 2014    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Basildon and Thurrock University Hospitals NHS Foundation Trust:
cardiac arrest
psychological intervention
Additional relevant MeSH terms:
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Heart Arrest
Heart Diseases
Cardiovascular Diseases