- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05631340
The Effects Of Discharge Education Program On Recovery And Quality Of Life After Cardiac Surgery
November 21, 2022 updated by: Eva Kajti, Istanbul University - Cerrahpasa (IUC)
This study aims to build a new discharge education, booklet and mobile application based, and assess it's efffects on recovery and quality of life in cardiac surgery patients.
This is a randomised control trial.
12 weeks follow up will be done by phone calls.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
Patients following cardiac surgery will be part of the study.
Patients will be randomized in control and case groups.
Control group receive standart discharge eduation from the nurses of the hospital, they will be interviewed by the researcher to gather general information and also information about recovery and quality of life.
Case group will be given a discharge education by the researcher before discharge.
After education patients will be given a booklet and a mobile application with the neccasary discharge information.
Both groups will be followed for 12 weeks by monthly phone calls.
In the last call recovery and quality of life will be reassesed.
Study Type
Interventional
Enrollment (Anticipated)
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Eva Kajti
- Phone Number: +905535213904
- Email: eva.kajti@iuc.edu.tr
Study Locations
-
-
Şişli
-
Istanbul, Şişli, Turkey, 34000
- Recruiting
- Istanbul Univesity-Cerrahpasa Florence Nightingale Faculty of Nursing
-
Contact:
- Eva Kajti
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- To agree to participate in the research,
- Open heart surgery patients
- Being 18 years or older,
- Being able to read, write, understand and communicate in Turkish,
- No vision, hearing and perception problems,
- Being conscious, oriented, cooperative and open to communication.
Exclusion Criteria:
• Having surgery other than open heart surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: case group
Recieving additional discharge education by the researcher and supported by a booklet and mobile app
|
Researcher's newly prepared discharge education supported by a booklet and mobile app
|
Active Comparator: control group
Recieving standart hoapital discharge education
|
Researcher's newly prepared discharge education supported by a booklet and mobile app
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recovery status after cardiac surgery
Time Frame: 12 weeks
|
Recovery -40 Questionnaire mesure recovery status before discharge and 12 weeks after discharge
|
12 weeks
|
Quality of Life after cardiac surgery
Time Frame: 12 weeks
|
Multidimensional Index of Life Quality questionnaire to mesure QoL before discharge and 12 weeks after discharge
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Ayfer Özbaş, Istanbul University-Cerrahpaşa Florence Nightingale Faculty of Nursing
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2022
Primary Completion (Actual)
November 18, 2022
Study Completion (Anticipated)
June 30, 2023
Study Registration Dates
First Submitted
November 21, 2022
First Submitted That Met QC Criteria
November 21, 2022
First Posted (Actual)
November 30, 2022
Study Record Updates
Last Update Posted (Actual)
November 30, 2022
Last Update Submitted That Met QC Criteria
November 21, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- Eva Kajti
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Research data will be given statistically without sharing IPD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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