NCT02955914

Brief Summary

Before a heart operation, patient outlook may be either pessimistic or optimistic. Previous research on this topic has focused on patient reported quality of life but has never examined measurable clinical outcomes such as length of hospital stay.This pilot study hopes to establish whether patient outlook (optimistic or pessimistic) before a heart operation can influence recovery and length of hospital stay. If there is a difference, then a case can be made for providing psychological support before an operation in the hope of modifying outlook and thus improving patient care and reducing hospital stay and NHS costs. Patients will be recruited over a 12month period. Their outlook (pessimistic or optimistic) will be ascertained using two standardised questionnaires. Their recovery and length of stay will be recorded. The study will answer the research question and determine whether outlook has an impact on recovery. Depending on the results, this study could provide opportunities for additional future research into modifying outlook with a view to improving patient care and recovery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
419

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
unknown

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, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 4, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 5, 2017

Status Verified

May 1, 2017

Enrollment Period

1.1 years

First QC Date

September 15, 2016

Last Update Submit

May 4, 2017

Conditions

Keywords

OptimismPessimismRecoveryElective Cardiac surgery

Outcome Measures

Primary Outcomes (1)

  • Length of hospital stay

    Discharge from hospital (average of 10 days)

Secondary Outcomes (2)

  • Length of ITU stay

    2 days

  • Risk-adjusted survival

    Discharge from hospital (average of 10 days)

Study Arms (2)

Optimism

Based on quality of life assessment

Pessimism

Based on quality of life assessment

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Eligible patients will be elective cardiac surgical patients undergoing major cardiac surgery.

You may qualify if:

  • Age over 18
  • Elective planned cardiac surgery
  • Consent to participate

You may not qualify if:

  • Patients diagnosed with clinical depression
  • Patients deemed not competent to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Papworth Hospital NHS Foundation Trust

Cambridge, CB23 3RE, United Kingdom

RECRUITING

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Christine Mills

    Papworth Hospital NHS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior R&D Manager

Study Record Dates

First Submitted

September 15, 2016

First Posted

November 4, 2016

Study Start

September 1, 2016

Primary Completion

October 1, 2017

Study Completion

December 1, 2017

Last Updated

May 5, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will share

The data will be disseminated among the research team. Patients can see a copy of the final report upon request.

Locations