Discharge Training and Telephone Counseling for Coronary Artery Bypass Graft PatientsNCT05104996
Discharge Training and Telephone Counseling
A study testing Telephone Counseling in people with Discharge Training and Telephone Counseling for Coronary Artery Bypass Graft Patients, run by Eastern Mediterranean University at 1 site in Cyprus.
Trial summary
The education and counseling role is one of the independent roles of the nurse. In this context, discharge training and telephone counseling given to patients who underwent coronary artery bypass graft surgery increase the ability of patients to cope with and adapt to their self-care. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Discharge Training and Telephone Counseling for Coronary Artery Bypass Graft Patients
- What is being tested?
- Telephone Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteCyprus
- Study dates
- 1 Sep 2020to 20 Jun 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having undergone CABG surgery,
- Being able to speak, read and write in Turkish,
- Not having a visual, hearing, physical, and mentally disability,
- Being aged over 18.
Who cannot join
- Being unable to speak, read and write in Turkish,
- Having a visual, hearing, physical, and mentally disability,
- Being aged under 18.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Discharge Training and Telephone Counseling on Self-Care Agency and Coping And Adaptation Process in Patients Undergoing Coronary Artery Bypass Graft: A Randomized Controlled Study
The education and counseling role is one of the independent roles of the nurse. In this context, discharge training and telephone counseling given to patients who underwent coronary artery bypass graft surgery increase the ability of patients to cope with and adapt to their self-care. This study was conducted to determine the effect of discharge training and telephone counseling on self-care agency, coping and adaptation process in patients undergoing coronary artery bypass graft surgery. The study has a randomized controlled, experimental design. Both experimental and control groups consisted of 35 individuals (N=70). Patients in the experimental group were given discharge training and telephone counseling service was given for two months. At the end of the process, data collection forms were administered to both groups for the last time. Necessary ethical approvals were taken and consent was taken from the patients. After the discharge training and telephone counseling given to the experimental group, the mean exercise of self-care agency scale score of the patients increased by 13.94; the mean coping and adaptation processing scale increased by 13.6. The mean exercise of self-care agency scale score of the control group increased by 7.86; the mean coping and adaptation processing score increased by 9.14. The effect size occurred for both groups was statistically significant (p<0.05). Positive results were achieved in the experimental group which received given discharge training and telephone counseling. It is recommended to provide planned discharge training and telephone counseling to patients undergoing coronary artery bypass graft surgery.
Read the detailed description
Coronary artery bypass graft (CABG) is the process of creating a bridge (grafting) to narrowed or clogged coronary arteries using artery and/or vein grafts. Discharge training has many effects such as pain management, reduction of home care visits, reduction of re-admissions to the hospital, acceleration of the recovery process, improvement of self-care agency, reduction of cost, reduction of anxiety level, enhancement of coping and adaptation, and patient satisfaction. Self-care, coping and adaptation remain important in promoting health. Self-care is defined as the decisions and practices made by individuals, who face health concerns, to cope with these concerns, improve their health, and enhance their adaptation. With these improved decisions and practice skills, patients can protect their health more actively. Besides self-care, coping and adaptation are other important issues in patient follow-up. The concept of coping and adaptation is defined as the cognitive and behavioral efforts of the individual to eliminate the necessities and obligations that occur in the inner and outer world, take them under control, and reduce the tension. These efforts may differ according to variables such as family support and spirituality. Patients who are insufficiently informed and not followed up in the postoperative period experience deficits in self-care and difficulties in coping and adaptation. Today, with the increase in the technology use, patient counseling by telephone can be provided for patient follow-up at home, monitoring drug side effects, counseling, sudden situations, appointment reminder, evaluation of the effectiveness of discharge training, determining training needs, performance evaluation, providing communication between hospital and home, increasing participation in training, improving self-care, increasing quality of life, ensuring coping and adaptation. Postoperative care outcomes and the patient's medical condition can be improved by ensuring continuity in telephone counseling. Postoperative mobile health applications are important in terms of evaluating changes, that may occur in the home environment, on time. Today, the rapid development of medicine and technology and the development of products that facilitate monitoring patients can help individuals who have undergone CABG surgery through telephone counseling and patient training. Training and telephone counseling services may reduce the number of hospital admissions, increase self-care agency, improve the quality of life, and enhance coping and adaptation.
- Being tested
- Telephone Counseling
- Keywords
- coronary artery bypass graft, discharge training, telephone counseling, self-care, coping and adaptation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone CounselingBehavioural
The form was used for weekly follow-up of the patients included in the experimental group. Headings were created according to the topics in the training form and/or for other problems and the problems stated by the patients were marked every week. Ongoing or eliminated problems of each patient until the time of next telephone counseling were indicated in the form. General problems in the form included drugs, pain, exercise, wound care, edema, compression socks, corset, nutrition, constipation, bathing, sleep, emergencies, back to work, sexual life, travel, visitors, climbing stairs, alcohol use/smoking, stress/anxiety, check-ups, and other issues.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | In the first interview, the patients were met and their consent for participation in the study was obtained. Afterwards, The Patient Descriptive Characteristics Form, ESCA and CAPS forms were filled. After this, patients were given discharge training and patient counseling service was provided by telephone for two months after discharge. At the end of two months, the ESCA and CAPS forms were filled again. Receives: Behavioral: Telephone Counseling |
| Control Group | No intervention | In the first interview, the patients were interviewed and their consent was obtained to participate in the study. Then, the Patient Descriptive Characteristics Form, ESCA and CAPS forms were filled. After this, the patients did not undergo any intervention for two months. At the end of two months, the ESCA and CAPS forms were filled again and a copy of the guideline was submitted. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise of Self-Care Agency Scale (ESCA)
The scale was developed by Kearney and Fleicher in 1979 and is originally a 43-item English form. The five-point Likert-type questionnaire aims to determine the ability of individuals to care for themselves and their self-care agency. The scale consists of statements scored from 0 to 4. It consists of a scale of 'very uncharacteristic of me' (0), 'somewhat uncharacteristic of me' (1), 'uncertain' (2), 'somewhat characteristic of me' (3), and 'very characteristic of me' (4) in each statement. Eight negative statements on the scale (3, 6, 9, 13, 19, 22, 26, and 31) are scored reversely. The lowest score obtainable from the scale is 35 and the highest score is 140.
Measured: 2 months
Coping and Adaptation Processing Scale (CAPS)
It is theoretically based on the Roy Adaptation Model and concepts related to its cognitive process. The scale consists of subscales such as troubleshooting and focusing, physical and conclusion, attention process, systematizing process, learning and establishing relationship. The number of items in the subdimensions is as follows: 'troubleshooting and focusing' involves 10 items; 'physical and conclusion' involves 14 items: 'attention process' involves 9 items; 'systematizing process' involves 6 items; 'learning and establishing relationship' involves 8 items. Items are scored on a Likert-type scale: 'never', 'rarely', 'sometimes', and 'always'.
Measured: 2 months
Secondary outcomes (1)
Telephone Counseling Patient Follow-up Form
The form was used for weekly follow-up of the patients included in the experimental group. Headings were created according to the topics in the training form and/or for other problems and the problems stated by the patients were marked every week. Ongoing or eliminated problems of each patient until the time of next telephone counseling were indicated in the form. General problems in the form included drugs, pain, exercise, wound care, edema, compression socks, corset, nutrition, constipation, bathing, sleep, emergencies, back to work, sexual life, travel, visitors, climbing stairs, alcohol use/smoking, stress/anxiety, check-ups, and other issues.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start1 Sep 2020
- Primary completion31 May 2021
- Study completion20 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Discharge Training and Telephone Counseling for Coronary Artery Bypass Graft PatientsStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ufuk Kaya, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05104996
- Sponsor's protocol ID
- EK015/20
- Other IDs
- Ümran Dal Yılmaz
- Status last verified
- Nov 2021
- First submitted
- 22 Oct 2021
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Naveed A, Azam H, Murtaza HG, Ahmad RA, Baig MAR. Incidence and risk factors of Pulmonary Complications after Cardiopulmonary bypass. Pak J Med Sci. 2017 Jul-Aug;33(4):993-996. doi: 10.12669/pjms.334.12846.
PubMed 29067080Yuroong A, Asdornwised U, Pinyopasakul W, Wongkornrat W, Chansatitporn N. The Effectiveness of the Transitional Care Program Among People Awaiting Coronary Artery Bypass Graft Surgery: A Randomized Control Trial. J Nurs Scholarsh. 2021 Sep;53(5):585-594. doi: 10.1111/jnu.12673. Epub 2021 May 19.
PubMed 34013579Williams B. Supporting self-care of patients following general abdominal surgery. J Clin Nurs. 2008 Mar;17(5):584-92. doi: 10.1111/j.1365-2702.2006.01857.x.
PubMed 18279291Jerant AF, Azari R, Martinez C, Nesbitt TS. A randomized trial of telenursing to reduce hospitalization for heart failure: patient-centered outcomes and nursing indicators. Home Health Care Serv Q. 2003;22(1):1-20. doi: 10.1300/J027v22n01_01.
PubMed 12749524Kaya U, Dal Yilmaz U. Ideal Suggestions for Discharge Training and Telephone Counseling of Patients With Coronary Artery Bypass Graft Surgery: A Randomized Controlled and Experimental Study. J Korean Med Sci. 2022 Sep 5;37(35):e269. doi: 10.3346/jkms.2022.37.e269.
PubMed 36065653
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Discharge Training and Telephone Counseling on Self-Care Agency and Coping And Adaptation Process in Patients Undergoing Coronary Artery Bypass Graft: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05104996
- Acronym / sponsor ID
- EK015/20
- Keywords
- coronary artery bypass graft, discharge training, telephone counseling, self-care, coping and adaptation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 20 Jun 2021 (actual)
- First posted
- 3 Nov 2021 (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.
The education and counseling role is one of the independent roles of the nurse. In this context, discharge training and telephone counseling given to patients who underwent coronary artery bypass graft surgery increase the ability of patients to cope with and adapt to their self-care. This study was conducted to determine the effect of discharge training and telephone counseling on self-care agency, coping and adaptation process in patients undergoing coronary artery bypass graft surgery. The study has a randomized controlled, experimental design. Both experimental and control groups consisted of 35 individuals (N=70). Patients in the experimental group were given discharge training and telephone counseling service was given for two months. At the end of the process, data collection forms were administered to both groups for the last time. Necessary ethical approvals were taken and consent was taken from the patients. After the discharge training and telephone counseling given to the experimental group, the mean exercise of self-care agency scale score of the patients increased by 13.94; the mean coping and adaptation processing scale increased by 13.6. The mean exercise of self-care agency scale score of the control group increased by 7.86; the mean coping and adaptation processing score increased by 9.14. The effect size occurred for both groups was statistically significant (p<0.05). Positive results were achieved in the experimental group which received given discharge training and telephone counseling. It is recommended to provide planned discharge training and telephone counseling to patients undergoing coronary artery bypass graft surgery.
Detailed description
Coronary artery bypass graft (CABG) is the process of creating a bridge (grafting) to narrowed or clogged coronary arteries using artery and/or vein grafts. Discharge training has many effects such as pain management, reduction of home care visits, reduction of re-admissions to the hospital, acceleration of the recovery process, improvement of self-care agency, reduction of cost, reduction of anxiety level, enhancement of coping and adaptation, and patient satisfaction. Self-care, coping and adaptation remain important in promoting health. Self-care is defined as the decisions and practices made by individuals, who face health concerns, to cope with these concerns, improve their health, and enhance their adaptation. With these improved decisions and practice skills, patients can protect their health more actively. Besides self-care, coping and adaptation are other important issues in patient follow-up. The concept of coping and adaptation is defined as the cognitive and behavioral efforts of the individual to eliminate the necessities and obligations that occur in the inner and outer world, take them under control, and reduce the tension. These efforts may differ according to variables such as family support and spirituality. Patients who are insufficiently informed and not followed up in the postoperative period experience deficits in self-care and difficulties in coping and adaptation. Today, with the increase in the technology use, patient counseling by telephone can be provided for patient follow-up at home, monitoring drug side effects, counseling, sudden situations, appointment reminder, evaluation of the effectiveness of discharge training, determining training needs, performance evaluation, providing communication between hospital and home, increasing participation in training, improving self-care, increasing quality of life, ensuring coping and adaptation. Postoperative care outcomes and the patient's medical condition can be improved by ensuring continuity in telephone counseling. Postoperative mobile health applications are important in terms of evaluating changes, that may occur in the home environment, on time. Today, the rapid development of medicine and technology and the development of products that facilitate monitoring patients can help individuals who have undergone CABG surgery through telephone counseling and patient training. Training and telephone counseling services may reduce the number of hospital admissions, increase self-care agency, improve the quality of life, and enhance coping and adaptation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Telephone CounselingIn the first interview, the patients were met and their consent for participation in the study was obtained. Afterwards, The Patient Descriptive Characteristics Form, ESCA and CAPS forms were filled. After this, patients were given discharge training and patient counseling service was provided by telephone for two months after discharge. At the end of two months, the ESCA and CAPS forms were filled again. |
| Control Group | No intervention | –In the first interview, the patients were interviewed and their consent was obtained to participate in the study. Then, the Patient Descriptive Characteristics Form, ESCA and CAPS forms were filled. After this, the patients did not undergo any intervention for two months. At the end of two months, the ESCA and CAPS forms were filled again and a copy of the guideline was submitted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Having undergone CABG surgery,
- Being able to speak, read and write in Turkish,
- Not having a visual, hearing, physical, and mentally disability,
- Being aged over 18.
Key exclusion criteria (3 listed)
- Being unable to speak, read and write in Turkish,
- Having a visual, hearing, physical, and mentally disability,
- Being aged under 18.
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 |
|---|---|---|
| Telephone CounselingThe form was used for weekly follow-up of the patients included in the experimental group. Headings were created according to the topics in the training form and/or for other problems and the problems stated by the patients were marked every week. Ongoing or eliminated problems of each patient until the time of next telephone counseling were indicated in the form. General problems in the form included drugs, pain, exercise, wound care, edema, compression socks, corset, nutrition, constipation, bathing, sleep, emergencies, back to work, sexual life, travel, visitors, climbing stairs, alcohol use/smoking, stress/anxiety, check-ups, and other issues. | Behavioural | Intervention Group |
Primary outcome
Exercise of Self-Care Agency Scale (ESCA)
Time frame: 2 months
The scale was developed by Kearney and Fleicher in 1979 and is originally a 43-item English form. The five-point Likert-type questionnaire aims to determine the ability of individuals to care for themselves and their self-care agency. The scale consists of statements scored from 0 to 4. It consists of a scale of 'very uncharacteristic of me' (0), 'somewhat uncharacteristic of me' (1), 'uncertain' (2), 'somewhat characteristic of me' (3), and 'very characteristic of me' (4) in each statement. Eight negative statements on the scale (3, 6, 9, 13, 19, 22, 26, and 31) are scored reversely. The lowest score obtainable from the scale is 35 and the highest score is 140.
Coping and Adaptation Processing Scale (CAPS)
Time frame: 2 months
It is theoretically based on the Roy Adaptation Model and concepts related to its cognitive process. The scale consists of subscales such as troubleshooting and focusing, physical and conclusion, attention process, systematizing process, learning and establishing relationship. The number of items in the subdimensions is as follows: 'troubleshooting and focusing' involves 10 items; 'physical and conclusion' involves 14 items: 'attention process' involves 9 items; 'systematizing process' involves 6 items; 'learning and establishing relationship' involves 8 items. Items are scored on a Likert-type scale: 'never', 'rarely', 'sometimes', and 'always'.
1 secondary outcome
Telephone Counseling Patient Follow-up Form
Time frame: 2 months
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 9 Nov 2021.
- Results publication: PubMed 29067080Naveed A, Azam H, Murtaza HG, Ahmad RA, Baig MAR. Incidence and risk factors of Pulmonary Complications after Cardiopulmonary bypass. Pak J Med Sci. 2017 Jul-Aug;33(4):993-996. doi: 10.12669/pjms.334.12846.
- Results publication: PubMed 34013579Yuroong A, Asdornwised U, Pinyopasakul W, Wongkornrat W, Chansatitporn N. The Effectiveness of the Transitional Care Program Among People Awaiting Coronary Artery Bypass Graft Surgery: A Randomized Control Trial. J Nurs Scholarsh. 2021 Sep;53(5):585-594. doi: 10.1111/jnu.12673. Epub 2021 May 19.
- Results publication: PubMed 18279291Williams B. Supporting self-care of patients following general abdominal surgery. J Clin Nurs. 2008 Mar;17(5):584-92. doi: 10.1111/j.1365-2702.2006.01857.x.
- Results publication: PubMed 12749524Jerant AF, Azari R, Martinez C, Nesbitt TS. A randomized trial of telenursing to reduce hospitalization for heart failure: patient-centered outcomes and nursing indicators. Home Health Care Serv Q. 2003;22(1):1-20. doi: 10.1300/J027v22n01_01.
- Derived from this study: PubMed 36065653Kaya U, Dal Yilmaz U. Ideal Suggestions for Discharge Training and Telephone Counseling of Patients With Coronary Artery Bypass Graft Surgery: A Randomized Controlled and Experimental Study. J Korean Med Sci. 2022 Sep 5;37(35):e269. doi: 10.3346/jkms.2022.37.e269.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone Counseling in people with Discharge Training and Telephone Counseling for Coronary Artery Bypass Graft Patients, run by Eastern Mediterranean University at 1 site in Cyprus.
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 4 inclusion and 3 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 9 Nov 2021. 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 Cyprus. 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?
Exercise of Self-Care Agency Scale (ESCA) (time frame: 2 months). 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 NCT05104996, which also lists 5 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 9 Nov 2021.