NCT05623813

Brief Summary

Cardiac surgery via sternotomy is performed on more than one million people annually. Patient education may promote engagement in daily activities postoperatively. It is unknown if there is any difference in patients' feedback and outcomes when the education is delivered individually or in a group format. The aim of this study is to collect participants' feedback and therapists' time spent on individual- and group-based Education in Daily Activities Engagement - Post-Sternotomy.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2016

Longer than P75 for all trials

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

August 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
5.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 21, 2022

Completed
Last Updated

November 21, 2022

Status Verified

November 1, 2022

Enrollment Period

7 months

First QC Date

November 1, 2022

Last Update Submit

November 13, 2022

Conditions

Keywords

patient educationindividual and group deliveryengagement in daily activities

Outcome Measures

Primary Outcomes (2)

  • Survey

    On participants' understanding, confidence, and satisfaction of the education

    Two to three days pre-discharge

  • Survey

    On participants' understanding, confidence, and satisfaction of the education

    Four to six weeks post-discharge

Secondary Outcomes (2)

  • Time spent delivering education per participant

    Post-discharge, up to six weeks

  • Length of postoperative hospital stay

    Post-discharge, up to six weeks

Study Arms (2)

Individual-based education

Participants in the individual-based education would receive tailored education on sternal precautions to facilitate engagement in daily activities.

Other: Postoperative education

Group-based education

Participants in the group-based education would receive the same education on sternal precautions to facilitate engagement in daily activities.The group-based education included between two and five participants. They were invited to ask questions about their recovery and voice any concerns they had about being discharged home specific to their needs, covering a tailored portion of the education. Participants in group-based education had a chance to share their experiences and concerns with the group members.

Other: Postoperative education

Interventions

provide patients with the understanding and confidence to safely engage in their daily activities whilst following post-sternotomy precautionary guidelines throughout their recovery

Group-based educationIndividual-based education

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients aged 18 or above who had received cardiac surgery via sternotomy at Liverpool Hospital cardiothoracic ward.

You may qualify if:

  • over the age of 18
  • had received cardiac surgery via sternotomy
  • were medically ready for discharge

You may not qualify if:

  • under the age of 18
  • unable to provide consent
  • did not speak English
  • could not obtain a translator prior to discharge
  • were infectious and required to isolate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

November 1, 2022

First Posted

November 21, 2022

Study Start

August 1, 2016

Primary Completion

March 1, 2017

Study Completion

August 26, 2022

Last Updated

November 21, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Individual participant data are not shared as per ethics protocol.