Clinical trial NCT02275234: Care After Resuscitation
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrest
Keywords: cardiac arrest
psychological intervention
Lead sponsor: Mid and South Essex NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Anglia Ruskin University
First posted: 2014-10-27
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retrospective and prospective cohort of patients following cardiac arrest

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Quality of Life as measured by responses on SF36
timeFrame: 6 months
measure: Change in cognitive function as measured by responses on Montreal Cognitive function tool
timeFrame: 6 months
measure: Change in cognitive function as measured by responses on Cogfail questionnaire
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Basildon
country: United Kingdom
facility: The Essex Cardiothoracic Centre
state: Essex
Study officials:
affiliation: Basildon and Thurrock University Hospitals NHS FT
name: Thomas R Keeble, MBBS MD MRCP
role: PRINCIPAL_INVESTIGATOR
References: