- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05623813
Individual- and Group-based Postoperative Education for Patients Sternotomy
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.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- over the age of 18
- had received cardiac surgery via sternotomy
- were medically ready for discharge
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Individual-based education
Participants in the individual-based education would receive tailored education on sternal precautions to facilitate engagement in daily activities.
|
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 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. |
provide patients with the understanding and confidence to safely engage in their daily activities whilst following post-sternotomy precautionary guidelines throughout their recovery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Survey
Time Frame: Two to three days pre-discharge
|
On participants' understanding, confidence, and satisfaction of the education
|
Two to three days pre-discharge
|
|
Survey
Time Frame: Four to six weeks post-discharge
|
On participants' understanding, confidence, and satisfaction of the education
|
Four to six weeks post-discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time spent delivering education per participant
Time Frame: Post-discharge, up to six weeks
|
The time spent for each session was measured in minutes using a timer from the start to the end of the education delivery
|
Post-discharge, up to six weeks
|
|
Length of postoperative hospital stay
Time Frame: Post-discharge, up to six weeks
|
Number of days between the date of surgery and the date of discharge
|
Post-discharge, up to six weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UWesternSydney_Aug2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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