Care After Resuscitation (CARE)

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Arrest
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 75

Contacts and Locations

Study Locations

• United Kingdom
  • Essex
    • Basildon, Essex, United Kingdom, SS16 5NL
      • The Essex Cardiothoracic Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Retrospective and prospective cohort of patients following cardiac arrest

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	6 months

Collaborators and Investigators

• Sponsor: Mid and South Essex NHS Foundation Trust
• Collaborators: Anglia Ruskin University
• Investigators: Principal Investigator: Thomas R Keeble, MBBS MD MRCP, Basildon and Thurrock University Hospitals NHS FT

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: October 17, 2014
• First Submitted That Met QC Criteria: October 23, 2014
• First Posted (Estimate): October 27, 2014

Study Record Updates

• Last Update Posted (Actual): September 8, 2021
• Last Update Submitted That Met QC Criteria: August 31, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: cardiac arrest; psychological intervention
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: B709

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No