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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02275234
Other study ID # B709
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2014
Est. completion date December 31, 2017

Study information

Verified date August 2021
Source Mid and South Essex NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date December 31, 2017
Est. primary completion date December 31, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Psychological intervention
Psychological support via clinic visit, helpline and telephone calls

Locations

Country Name City State
United Kingdom The Essex Cardiothoracic Centre Basildon Essex

Sponsors (2)

Lead Sponsor Collaborator
Mid and South Essex NHS Foundation Trust Anglia Ruskin University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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