Coronary Artery Bypass GraftNCT05737901
The Effect of Different Training Methods On Discharge
A study testing Education Booklet and Mobile application in people with Coronary Artery Bypass Graft and Discharge Education, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to examine the effects of different discharge training methods on readiness to discharge and self-efficacy in individuals undergoing coronary artery bypass graft surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Bypass Graft, Discharge Education
- What is being tested?
- Education Booklet and Mobile application
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2019to 1 Mar 2022
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being literate
- Understanding and speaking the Turkish language
- Having undergone a planned open-heart surgery for the first time.
Who cannot join
- Patients who received psychiatric diagnosis
- Who were unable to use the tablet and mobile application after explanations
- Who had postoperative hospitalization for more than 10 days
- Who had a development of disorientation in the postoperative service
- Who had a valve surgery added to their CABG surgery during the operation were excluded from the research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Different Discharge Training Methods On Readiness and Self-Efficacy for Discharge After Coronary Artery Bypass Surgery: A Randomized Uncontrolled Clinical Study
This study was conducted to examine the effects of different discharge training methods on readiness to discharge and self-efficacy in individuals undergoing coronary artery bypass graft surgery.
Read the detailed description
With the shortening of the length of hospital stay after coronary artery bypass graft (CABG) surgery, patients can be discharged by taking on complex responsibilities before the healing process is completed and before their perception of self-efficacy increases. Today, in the discharge training traditionally given with oral or written materials after surgery, the subjects that are generally considered important are selected, which may lead to not addressing the specific needs of individuals. In addition, inconsistencies may occur due to the trainer, too much written information that is beyond the knowledge level of the patients, frequent forgetting or incorrect remembering of the information given, and the incompatibility between the time planned by the nurse for the training and the time the patient feels ready. In one study, it was reported that 55.3% of the nurses did not provide patient education, education was in the seventh place in their daily work routines, and the reasons for not training the patients were their excessive workload and inability to use time effectively. For this reason, traditional patient education methods have begun to be replaced by technological methods. Mobile applications create opportunities for patients to participate in their own care during their hospital stay in the remaining time spent on examinations and treatments. It has been reported that video interventions are extremely effective, especially in populations with low literacy rates, and longer-term information transfer can be achieved by leaving tablets used for educational purposes in the patient room.
CABG surgery is most needed during middle and advanced ages. However, it is generally known that elderly individuals are mostly not familiar with recent mobile technologies. In Turkey, no research has been found on whether this patient group is suitable for using mobile technologies, the effectiveness of tablets in providing information to inpatients, the extent to which patients are interested and engaged with the application, the effectiveness of the application to bring the patient to a readiness state for discharge, the effect of the application on the perception of self-efficacy, and how it affects the state of satisfaction. Some authors also state that well-designed and reported studies are needed to demonstrate the effectiveness of mobile phone or tablet-based applications in the management of CAD (Coronary Artery Disease).
- Conditions
- Coronary Artery Bypass Graft, Discharge Education
- Being tested
- Education Booklet, Mobile application
- Keywords
- mobile applications, education, self efficacy, discharge readiness, coronary artery bypass, nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education BookletOther
Training titles and contents were created by listing the most common complications and needs of patients after CABG surgery. In the "General Information" section of the booklet, the definition of CAD, how CABG surgery is performed, the length of hospital stay, and what can be experienced in the hospital after surgery and in the home environment after discharge were discussed. In the "Postoperative Self-Care Practices" section, information about the healing process of the breastbone, pain management, medication, respiratory exercises, early nutrition, personal hygiene, protection from coronavirus-19, pulse control, postoperative heart attack, conditions to be reported, compression stockings use for varicose veins, physical activity, travel, sleep and rest, sexual life, and coping with stress and depression was presented. In the "Postoperative Life" section, training topics on exercise, nutrition, smoking, and alcohol use were included.
Mobile applicationOther
The logo and content of the "Bypass e-Discharge" application was visually designed, and the software was developed. In-app transactions were secured with end-to-end encryption by entering the username and password, and internet access was not required to use the application. The application was presented for expert opinion (3 patients, 1 academician, 2 nurses, 2 physicians) in order to investigate the user experience, and edits were made on its interface (such as adding the "acceleration" feature in videos, an additional button for stopping and starting videos, displaying video total time on the screen, and magnification of all buttons).
| Study group | Role | What they receive |
|---|---|---|
| Standard care group | No intervention | The standard discharge training of the clinic was carried out in the patient's room on the day of discharge in an average of 5 minutes, in the form of verbally explaining the information deemed important by the physician and/or nurse to the patient. No intervention was made in this group. |
| Education Booklet Group | Experimental | Discharge training was given by the researcher the day before the surgery in an average of 60 minutes in the meeting room of the clinic through the booklet. Receives: Other: Education Booklet |
| Mobile Application Group | Experimental | The mobile application was introduced to the patient by the researcher the day before the surgery. During the presentation phase, the patient was informed about the titles and contents of the training videos, and after explaining the technical features related to turning the tablet on and off, raising and lowering the volume, logging into the account using the username and password for training, using the buttons on the main screen and the keyboard, the patient was asked to apply them. All these stages took an average of 20 minutes. In addition, information about logging in, such as how to switch on and off the device, the patient's user name and password, were added to the back of the tablet in writing. Receives: Other: Mobile application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barnason Efficacy Expectation Scale (BEES) - Cardiac Surgery Version
The increasing score indicates that the individual's expectation of self-efficacy regarding recovery and behavioral changes is also high.
Measured: on the day of discharge after standard care, estimated average 7 days and one month after discharge
Readiness for Hospital Discharge Scale
The patient with a ready-to-discharge score of 7 and above is considered ready to be discharged, whereas a score below 7 indicates that the patient is not ready.
Measured: on the day of discharge after standard care, estimated average 7 days
Secondary outcomes (2)
System Usability Scale (SUS)
The increasing score indicates that the usability of the developed system has increased
Measured: on the day of discharge after standard care, estimated average 7 days
Net Promoter Score
People who respond with a score of 9 or 10 are labeled as 'promoters,' those who receive a score of 7 or 8 are labeled as 'neutrals,' and those who score 6 or less are labeled as 'detractors.'
Measured: on the day of discharge after standard care, estimated average 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start15 Aug 2019
- Primary completion3 Oct 2019
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Bypass GraftStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study was carried out quasi-experimentally.
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilara ŞAHAN, Aydin Adnan Menderes University
- Investigators
- Dilara ŞAHAN, PhD, Principal investigator, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05737901
- Sponsor's protocol ID
- AdnanU
- Status last verified
- Jul 2023
- First submitted
- 31 Jan 2023
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cook DJ, Moradkhani A, Douglas KS, Prinsen SK, Fischer EN, Schroeder DR. Patient education self-management during surgical recovery: combining mobile (iPad) and a content management system. Telemed J E Health. 2014 Apr;20(4):312-7. doi: 10.1089/tmj.2013.0219. Epub 2014 Jan 20.
PubMed 24443928Greysen SR, Khanna RR, Jacolbia R, Lee HM, Auerbach AD. Tablet computers for hospitalized patients: a pilot study to improve inpatient engagement. J Hosp Med. 2014 Jun;9(6):396-9. doi: 10.1002/jhm.2169. Epub 2014 Feb 13.
PubMed 24523051Noor Hanita Z, Khatijah LA, Kamaruzzaman S, Karuthan C, Raja Mokhtar RA. A pilot study on development and feasibility of the 'MyEducation: CABG application' for patients undergoing coronary artery bypass graft (CABG) surgery. BMC Nurs. 2022 Feb 4;21(1):40. doi: 10.1186/s12912-022-00814-4.
PubMed 35120517van Steenbergen GJ, van Veghel D, Ter Woorst J, van Lieshout D, Dekker L. IMPROV-ED trial: eHealth programme for faster recovery and reduced healthcare utilisation after CABG. Neth Heart J. 2021 Feb;29(2):80-87. doi: 10.1007/s12471-020-01508-9. Epub 2020 Nov 3.
PubMed 33141398
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Discharge Training Methods On Readiness and Self-Efficacy for Discharge After Coronary Artery Bypass Surgery: A Randomized Uncontrolled Clinical Study
- ClinicalTrials.gov ID
- NCT05737901
- Acronym / sponsor ID
- AdnanU
- Conditions
- Coronary Artery Bypass Graft, Discharge Education
- Keywords
- mobile applications, education, self efficacy, discharge readiness, coronary artery bypass, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 3 Oct 2019 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 21 Feb 2023 (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.
This study was conducted to examine the effects of different discharge training methods on readiness to discharge and self-efficacy in individuals undergoing coronary artery bypass graft surgery.
Detailed description
With the shortening of the length of hospital stay after coronary artery bypass graft (CABG) surgery, patients can be discharged by taking on complex responsibilities before the healing process is completed and before their perception of self-efficacy increases. Today, in the discharge training traditionally given with oral or written materials after surgery, the subjects that are generally considered important are selected, which may lead to not addressing the specific needs of individuals. In addition, inconsistencies may occur due to the trainer, too much written information that is beyond the knowledge level of the patients, frequent forgetting or incorrect remembering of the information given, and the incompatibility between the time planned by the nurse for the training and the time the patient feels ready. In one study, it was reported that 55.3% of the nurses did not provide patient education, education was in the seventh place in their daily work routines, and the reasons for not training the patients were their excessive workload and inability to use time effectively. For this reason, traditional patient education methods have begun to be replaced by technological methods. Mobile applications create opportunities for patients to participate in their own care during their hospital stay in the remaining time spent on examinations and treatments. It has been reported that video interventions are extremely effective, especially in populations with low literacy rates, and longer-term information transfer can be achieved by leaving tablets used for educational purposes in the patient room.
CABG surgery is most needed during middle and advanced ages. However, it is generally known that elderly individuals are mostly not familiar with recent mobile technologies. In Turkey, no research has been found on whether this patient group is suitable for using mobile technologies, the effectiveness of tablets in providing information to inpatients, the extent to which patients are interested and engaged with the application, the effectiveness of the application to bring the patient to a readiness state for discharge, the effect of the application on the perception of self-efficacy, and how it affects the state of satisfaction. Some authors also state that well-designed and reported studies are needed to demonstrate the effectiveness of mobile phone or tablet-based applications in the management of CAD (Coronary Artery Disease).
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The study was carried out quasi-experimentally.
| Arm | Type | Receives |
|---|---|---|
| Standard care group | No intervention | –The standard discharge training of the clinic was carried out in the patient's room on the day of discharge in an average of 5 minutes, in the form of verbally explaining the information deemed important by the physician and/or nurse to the patient. No intervention was made in this group. |
| Education Booklet Group | Experimental | Other: Education BookletDischarge training was given by the researcher the day before the surgery in an average of 60 minutes in the meeting room of the clinic through the booklet. |
| Mobile Application Group | Experimental | Other: Mobile applicationThe mobile application was introduced to the patient by the researcher the day before the surgery. During the presentation phase, the patient was informed about the titles and contents of the training videos, and after explaining the technical features related to turning the tablet on and off, raising and lowering the volume, logging into the account using the username and password for training, using the buttons on the main screen and the keyboard, the patient was asked to apply them. All these stages took an average of 20 minutes. In addition, information about logging in, such as how to switch on and off the device, the patient's user name and password, were added to the back of the tablet in writing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being literate
- Understanding and speaking the Turkish language
- Having undergone a planned open-heart surgery for the first time.
Key exclusion criteria (5 listed)
- Patients who received psychiatric diagnosis
- Who were unable to use the tablet and mobile application after explanations
- Who had postoperative hospitalization for more than 10 days
- Who had a development of disorientation in the postoperative service
- Who had a valve surgery added to their CABG surgery during the operation were excluded from the research.
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 |
|---|---|---|
| Education BookletTraining titles and contents were created by listing the most common complications and needs of patients after CABG surgery. In the "General Information" section of the booklet, the definition of CAD, how CABG surgery is performed, the length of hospital stay, and what can be experienced in the hospital after surgery and in the home environment after discharge were discussed. In the "Postoperative Self-Care Practices" section, information about the healing process of the breastbone, pain management, medication, respiratory exercises, early nutrition, personal hygiene, protection from coronavirus-19, pulse control, postoperative heart attack, conditions to be reported, compression stockings use for varicose veins, physical activity, travel, sleep and rest, sexual life, and coping with stress and depression was presented. In the "Postoperative Life" section, training topics on exercise, nutrition, smoking, and alcohol use were included. | Other | Education Booklet Group |
| Mobile applicationThe logo and content of the "Bypass e-Discharge" application was visually designed, and the software was developed. In-app transactions were secured with end-to-end encryption by entering the username and password, and internet access was not required to use the application. The application was presented for expert opinion (3 patients, 1 academician, 2 nurses, 2 physicians) in order to investigate the user experience, and edits were made on its interface (such as adding the "acceleration" feature in videos, an additional button for stopping and starting videos, displaying video total time on the screen, and magnification of all buttons). | Other | Mobile Application Group |
Primary outcome
Barnason Efficacy Expectation Scale (BEES) - Cardiac Surgery Version
Time frame: on the day of discharge after standard care, estimated average 7 days and one month after discharge
The increasing score indicates that the individual's expectation of self-efficacy regarding recovery and behavioral changes is also high.
Readiness for Hospital Discharge Scale
Time frame: on the day of discharge after standard care, estimated average 7 days
The patient with a ready-to-discharge score of 7 and above is considered ready to be discharged, whereas a score below 7 indicates that the patient is not ready.
2 secondary outcomes
System Usability Scale (SUS)
Time frame: on the day of discharge after standard care, estimated average 7 days
Net Promoter Score
Time frame: on the day of discharge after standard care, estimated average 7 days
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 20 Jul 2023.
- Results publication: PubMed 24443928Cook DJ, Moradkhani A, Douglas KS, Prinsen SK, Fischer EN, Schroeder DR. Patient education self-management during surgical recovery: combining mobile (iPad) and a content management system. Telemed J E Health. 2014 Apr;20(4):312-7. doi: 10.1089/tmj.2013.0219. Epub 2014 Jan 20.
- Results publication: PubMed 24523051Greysen SR, Khanna RR, Jacolbia R, Lee HM, Auerbach AD. Tablet computers for hospitalized patients: a pilot study to improve inpatient engagement. J Hosp Med. 2014 Jun;9(6):396-9. doi: 10.1002/jhm.2169. Epub 2014 Feb 13.
- Results publication: PubMed 35120517Noor Hanita Z, Khatijah LA, Kamaruzzaman S, Karuthan C, Raja Mokhtar RA. A pilot study on development and feasibility of the 'MyEducation: CABG application' for patients undergoing coronary artery bypass graft (CABG) surgery. BMC Nurs. 2022 Feb 4;21(1):40. doi: 10.1186/s12912-022-00814-4.
- Results publication: PubMed 33141398van Steenbergen GJ, van Veghel D, Ter Woorst J, van Lieshout D, Dekker L. IMPROV-ED trial: eHealth programme for faster recovery and reduced healthcare utilisation after CABG. Neth Heart J. 2021 Feb;29(2):80-87. doi: 10.1007/s12471-020-01508-9. Epub 2020 Nov 3.
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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.
Dilara ŞAHAN, PhD principal investigator
Aydin Adnan Menderes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education Booklet and Mobile application in people with Coronary Artery Bypass Graft and Discharge Education, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
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 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Barnason Efficacy Expectation Scale (BEES) - Cardiac Surgery Version (time frame: on the day of discharge after standard care, estimated average 7 days and one month after 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?
On the ClinicalTrials.gov record for NCT05737901, which also lists 4 linked publications.
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 20 Jul 2023.