Post-sternotomyNCT05623813
Individual- and Group-based Postoperative Education for Patients Sternotomy
An observational study of Post-sternotomy, run by University of Western Sydney.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Post-sternotomy
- What is being tested?
- Postoperative education
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to 26 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients aged 18 or above who had received cardiac surgery via sternotomy at Liverpool Hospital cardiothoracic ward.
Who may be able to join
- over the age of 18
- had received cardiac surgery via sternotomy
- were medically ready for discharge
Who cannot join
- 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
About this study
Official title: Individual- and Group-based Postoperative Education on Promoting Engagement in Daily Activities for Patients After Sternotomy: A Non-randomised Controlled Study
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.
Read the detailed description
This single-site non-randomised controlled study was conducted at Liverpool Hospital, NSW, Australia. All patients aged 18 or above who had received cardiac surgery via sternotomy at Liverpool Hospital cardiothoracic ward were consecutively allocated to the individual- or group-based postoperative education. Outcomes included a survey to obtain participants' feedback, the time spent by therapists delivering the education per participant, and participants' length of postoperative hospital stay.
- Conditions
- Post-sternotomy
- Being tested
- Postoperative education
- Keywords
- patient education, individual and group delivery, engagement in daily activities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative educationOther
provide patients with the understanding and confidence to safely engage in their daily activities whilst following post-sternotomy precautionary guidelines throughout their recovery
| Study group | Role | What they receive |
|---|---|---|
| Individual-based education | Participants in the individual-based education would receive tailored education on sternal precautions to facilitate engagement in daily activities. Receives: 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. Receives: Other: Postoperative education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survey
On participants' understanding, confidence, and satisfaction of the education
Measured: Two to three days pre-discharge
Survey
On participants' understanding, confidence, and satisfaction of the education
Measured: Four to six weeks post-discharge
Secondary outcomes (2)
Time spent delivering education per participant
The time spent for each session was measured in minutes using a timer from the start to the end of the education delivery
Measured: Post-discharge, up to six weeks
Length of postoperative hospital stay
Number of days between the date of surgery and the date of discharge
Measured: Post-discharge, up to six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study startAug 2016
- Primary completionMar 2017
- Study completion26 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-sternotomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Western Sydney
- Sponsor type
- University, hospital or other
- Collaborators
- Liverpool Hospital
- Responsible party
- Principal investigator, Karen Liu, University of Western Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05623813
- Sponsor's protocol ID
- UWesternSydney_Aug2022
- Status last verified
- Nov 2022
- First submitted
- 1 Nov 2022
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not shared as per ethics protocol.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual- and Group-based Postoperative Education on Promoting Engagement in Daily Activities for Patients After Sternotomy: A Non-randomised Controlled Study
- ClinicalTrials.gov ID
- NCT05623813
- Acronym / sponsor ID
- UWesternSydney_Aug2022
- Conditions
- Post-sternotomy
- Keywords
- patient education, individual and group delivery, engagement in daily activities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of Western SydneyUniversity, hospital or other
- Collaborators
- Liverpool Hospital
- Study start
- Aug 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- 26 Aug 2022 (actual)
- First posted
- 21 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This single-site non-randomised controlled study was conducted at Liverpool Hospital, NSW, Australia. All patients aged 18 or above who had received cardiac surgery via sternotomy at Liverpool Hospital cardiothoracic ward were consecutively allocated to the individual- or group-based postoperative education. Outcomes included a survey to obtain participants' feedback, the time spent by therapists delivering the education per participant, and participants' length of postoperative hospital stay.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individual-based education | – | Other: Postoperative educationParticipants in the individual-based education would receive tailored education on sternal precautions to facilitate engagement in daily activities. |
| Group-based education | – | Other: Postoperative educationParticipants 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients aged 18 or above who had received cardiac surgery via sternotomy at Liverpool Hospital cardiothoracic ward.
Key inclusion criteria (3 listed)
- over the age of 18
- had received cardiac surgery via sternotomy
- were medically ready for discharge
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postoperative educationprovide patients with the understanding and confidence to safely engage in their daily activities whilst following post-sternotomy precautionary guidelines throughout their recovery | Other | Group-based education, Individual-based education |
Primary outcome
Survey
Time frame: Two to three days pre-discharge
On participants' understanding, confidence, and satisfaction of the education
Survey
Time frame: Four to six weeks post-discharge
On participants' understanding, confidence, and satisfaction of the education
2 secondary outcomes
Time spent delivering education per participant
Time frame: Post-discharge, up to six weeks
Length of postoperative hospital stay
Time frame: Post-discharge, up to six weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
- Individual participant dataSharing planned: No. Individual participant data are not shared as per ethics protocol.
Related trials for Post-sternotomy
Not yet recruiting
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Chronic Postoperative Pain, Chronic Post-Sternotomy Pain
RecruitingPhase 3
Suzetrigine-enhanced MultimOdal Opioid-sparing THerapy in Cardiac and Bariatric SURGery
Bariatric Surgery, Cardiac Surgery With Sternotomy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-sternotomy, run by University of Western Sydney.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survey (time frame: Two to three days pre-discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2022; AzTrials last refreshed its copy on 6 Nov 2026.