Acute Myocardial InfarctionNCT06034054
Acute Coronary Syndrome and Nurse Counselling
A study testing nursing counceling in people with Acute Myocardial Infarction and Coronary Artery Disease, run by Iskenderun State Hospital at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to examine in patients with acute coronary syndrome. The main questions it aims to answer are: Does nurse counseling affect quality of life? Does nurse counseling affect functional capacity? Does nurse counseling affect knowledge, attitudes and beliefs about syndromes? Participants… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Myocardial Infarction, Coronary Artery Disease
- What is being tested?
- nursing counceling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2020to 1 Jul 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old, diagnosed with Acute Coronary Syndrome and treated with a stent,
- Treatment preventing communication is not a problem, literate,
- There is no obstacle to performing the 6-minute walk test.
- who did not accept to participate, were included in the study.
Who cannot join
- <18 years of age,
- Mental or cognitive impairment,
- Diagnosed with SpO2 <80,
- Peripheral arterial disease, lower extremity amputation, impaired tumor or open wound of lower extremity, and deep vein thrombosis, 6 munites corridor Walk test Parts of individuals who are contraindicated in making are not included.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Nurse Counselling on Quality of Life, Functional Capacity and Knowledge, Attitudes and Beliefs in Patients With Acute Coronary Syndrome
The goal of this clinical trial is to examine in patients with acute coronary syndrome. The main questions it aims to answer are:
- Does nurse counseling affect quality of life?
- Does nurse counseling affect functional capacity?
- Does nurse counseling affect knowledge, attitudes and beliefs about syndromes?
Participants will be trained using the training booklet, and nursing counseling will then be provided for six months.
If there is a comparison group: Researchers will compare with the control group to see if the nurse counseling has had an effect.
Read the detailed description
After obtaining verbal and written consent from the participants, they are required to answer the questions on the Diagnosis Form, Acute Coronary Syndrome Response Index, and Multiple Quality of Life Scale. Then, preliminary measurements will be made and a 6-minute corridor walking test will be applied. While the control group will be followed up routinely, the training booklet prepared for the intervention group will be explained orally. Participants will then be informed that they will be called monthly. They will be told that they can reach these monthly calls and consult the nurse when they need it. After this stage, interviews with patients will begin. The standard way of communication with the participants by the researchers is by telephone, and a total of 6 interviews will be provided, the first of which is in the 1st month after the application of the tests. In each call, all the information in the training booklet will be repeated, additional information will be given in line with the needs and demands of the person, their questions will be answered and the interview will be ended. Although it varies according to the individual interviewed, it is predicted that these telephone interviews will last for 30 minutes on average. Apart from these standard calls, individuals in need will be able to reach the researcher face-to-face during phone calls, text messages, instant messaging methods or hospital visits, and in this way, the counseling process will continue actively for 6 months. After six months, the final tests will be done.
- Being tested
- nursing counceling
- Keywords
- Acute Coronary Syndrome, Counseling, Nursing
- Medical subject headings
- Coronary Artery Disease, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nursing councelingOther
- Providing an educational booklet containing information about pastry, verbally explaining the content of the prepared educational booklet.
- Answering the information and questions that the patient needs in addition, and receiving contact information in October.
- Monthly calls will be made to patients 6. providing information that the same tests will be performed again per month, if necessary, this monthly call counseling by reaching out without waiting indicating what they can receive.
| Study group | Role | What they receive |
|---|---|---|
| Nursing counseling | Experimental | The individuals included in nursing counseling group were given counseling by the research nurse for 6 months. Receives: Other: nursing counceling |
| Control | No intervention | Individuals included in control group were followed up routinely in the outpatient clinic for 6 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Life quality
Multidimensional index of life quality will be applied(This scale is the "multidimensional quality of life scale", the Turkish validity and reliability of which was established in 2012.)
Measured: 6 mounth
Functional capacity
Functional Capacity Evaluation Form will be applied.
Measured: 6 mounth
Acute Coronary Syndromes
Acute Coronary Syndrome Response Index will be applied.It was translated into Turkish and a reliability and validity study was conducted in 2016. A questionnaire consisting of 33 items was applied to evaluate the knowledge, attitudes and beliefs of individuals with acute coronary syndrome regarding the disease.
Measured: 6 mount
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Jul 2020
- Primary completion1 Feb 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies 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
- Participant, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iskenderun State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deniz Gülistan ER, Iskenderun State Hospital
- Investigators
- sevgin samancıoğlu bağlama, assoc.prof, Study director, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06034054
- Sponsor's protocol ID
- DGulistan-01
- Status last verified
- Sep 2023
- First submitted
- 26 Aug 2023
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nurse Counselling on Quality of Life, Functional Capacity and Knowledge, Attitudes and Beliefs in Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT06034054
- Acronym / sponsor ID
- DGulistan-01
- Keywords
- Acute Coronary Syndrome, Counseling, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Iskenderun State HospitalUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 13 Sep 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.
The goal of this clinical trial is to examine in patients with acute coronary syndrome. The main questions it aims to answer are:
- Does nurse counseling affect quality of life?
- Does nurse counseling affect functional capacity?
- Does nurse counseling affect knowledge, attitudes and beliefs about syndromes?
Participants will be trained using the training booklet, and nursing counseling will then be provided for six months.
If there is a comparison group: Researchers will compare with the control group to see if the nurse counseling has had an effect.
Detailed description
After obtaining verbal and written consent from the participants, they are required to answer the questions on the Diagnosis Form, Acute Coronary Syndrome Response Index, and Multiple Quality of Life Scale. Then, preliminary measurements will be made and a 6-minute corridor walking test will be applied. While the control group will be followed up routinely, the training booklet prepared for the intervention group will be explained orally. Participants will then be informed that they will be called monthly. They will be told that they can reach these monthly calls and consult the nurse when they need it. After this stage, interviews with patients will begin. The standard way of communication with the participants by the researchers is by telephone, and a total of 6 interviews will be provided, the first of which is in the 1st month after the application of the tests. In each call, all the information in the training booklet will be repeated, additional information will be given in line with the needs and demands of the person, their questions will be answered and the interview will be ended. Although it varies according to the individual interviewed, it is predicted that these telephone interviews will last for 30 minutes on average. Apart from these standard calls, individuals in need will be able to reach the researcher face-to-face during phone calls, text messages, instant messaging methods or hospital visits, and in this way, the counseling process will continue actively for 6 months. After six months, the final tests will be done.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nursing counseling | Experimental | Other: nursing councelingThe individuals included in nursing counseling group were given counseling by the research nurse for 6 months. |
| Control | No intervention | –Individuals included in control group were followed up routinely in the outpatient clinic for 6 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years old, diagnosed with Acute Coronary Syndrome and treated with a stent,
- Treatment preventing communication is not a problem, literate,
- There is no obstacle to performing the 6-minute walk test.
- who did not accept to participate, were included in the study.
Key exclusion criteria (4 listed)
- <18 years of age,
- Mental or cognitive impairment,
- Diagnosed with SpO2 <80,
- Peripheral arterial disease, lower extremity amputation, impaired tumor or open wound of lower extremity, and deep vein thrombosis, 6 munites corridor Walk test Parts of individuals who are contraindicated in making are not included.
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 |
|---|---|---|
| nursing counceling* Providing an educational booklet containing information about pastry, verbally explaining the content of the prepared educational booklet. * Answering the information and questions that the patient needs in addition, and receiving contact information in October. * Monthly calls will be made to patients 6. providing information that the same tests will be performed again per month, if necessary, this monthly call counseling by reaching out without waiting indicating what they can receive. | Other | Nursing counseling |
Primary outcome
Life quality
Time frame: 6 mounth
Multidimensional index of life quality will be applied(This scale is the "multidimensional quality of life scale", the Turkish validity and reliability of which was established in 2012.)
Functional capacity
Time frame: 6 mounth
Functional Capacity Evaluation Form will be applied.
Acute Coronary Syndromes
Time frame: 6 mount
Acute Coronary Syndrome Response Index will be applied.It was translated into Turkish and a reliability and validity study was conducted in 2016. A questionnaire consisting of 33 items was applied to evaluate the knowledge, attitudes and beliefs of individuals with acute coronary syndrome regarding the disease.
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 14 Sep 2023.
- Individual participant dataSharing planned: No
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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.
sevgin samancıoğlu bağlama, assoc.prof study director
Muğla Sıtkı Koçman 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 nursing counceling in people with Acute Myocardial Infarction and Coronary Artery Disease, run by Iskenderun State Hospital 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 4 inclusion and 4 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 14 Sep 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?
Life quality (time frame: 6 mounth). The study lists 3 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 14 Sep 2023.