NCT02275234

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 27, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

September 8, 2021

Status Verified

August 1, 2021

Enrollment Period

3.3 years

First QC Date

October 17, 2014

Last Update Submit

August 31, 2021

Conditions

Keywords

cardiac arrestpsychological intervention

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

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

Interventions

Psychological support via clinic visit, helpline and telephone calls

Prospective- psychological intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Retrospective and prospective cohort of patients following cardiac arrest

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Essex Cardiothoracic Centre

Basildon, Essex, SS16 5NL, United Kingdom

Location

MeSH Terms

Conditions

Heart Arrest

Interventions

Psychosocial Intervention

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Thomas R Keeble, MBBS MD MRCP

    Basildon and Thurrock University Hospitals NHS FT

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2014

First Posted

October 27, 2014

Study Start

September 1, 2014

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

September 8, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations