Have a Diagnosis of Coronary Artery DiseaseNCT05980364
Cardiac Rehabilitation in Coronary Artery Diseases
A study testing Technology-based training structured according to the Health Promotion Model in people with Have a Diagnosis of Coronary Artery Disease, run by Hatice Karabulak at 1 site in Turkey (Türkiye).
Trial summary
Cardiac rehabilitation is approaches that focus on accelerating the recovery process of patients after a cardiac event, improving their physical, psychological and social conditions, and controlling risk factors. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Have a Diagnosis of Coronary Artery Disease
- What is being tested?
- Technology-based training structured according to the Health Promotion Model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2022to 15 Sep 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 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having a diagnosis of coronary artery disease (acute coronary syndrome, coronary revascularization, atherosclerotic heart disease, etc.),
- Being stable in health (the patient's health status does not change suddenly and is under control),
- If an interventional procedure has been performed, at least three months have passed after discharge,
- Being between the ages of 18-65,
- Being literate,
- Using smart phone and internet,
- Living in the city center
Who cannot join
- Having a disability (vision, hearing, neurological, cognitive, etc.) that may interfere with education,
- Cardiac rehabilitation is contraindicated
- To have participated in a cardiac rehabilitation program given by another institution before or during the study,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kars Harakani State Hospital
Kars, Merkez, 36100
About this study
Official title: In Cardiac Rehabilitation The Effect of Technology-Based Education Structured According to the Health Promotion Model on Healthy Lifestyle Behaviors, Health Fatalism and Risk Knowledge Level: A Randomized Controlled Study
Cardiac rehabilitation is approaches that focus on accelerating the recovery process of patients after a cardiac event, improving their physical, psychological and social conditions, and controlling risk factors. Cardiac rehabilitation is known to be an effective and cost-effective approach in the secondary prevention of cardiovascular diseases, most of which are caused by preventable risks. Ischemic heart diseases, one of the cardiovascular diseases, are responsible for 16% of total deaths in the world and have increased significantly since 2000, causing 8.9 million deaths in 2019.
When coronary artery diseases cannot be prevented, the basic approach should be to ensure the individual's compliance with treatment and healthy lifestyle behaviors, and to increase the quality of life and life span.
Read more
For this reason, the aim of the study is to examine the effects of technology-based education structured according to the health promotion model in cardiac rehabilitation on healthy lifestyle behaviors, health fatalism and risk knowledge level.
Question 1. Does technology-based education structured according to the health promotion model affect the healthy lifestyle behaviors score? Question 2. Does technology-based education structured according to the health promotion model affect the health fatalism score? Question 3. Does technology-based education structured according to the health promotion model affect the cardiovascular disease risk factors knowledge level score?
- Being tested
- Technology-based training structured according to the Health Promotion Model
- Keywords
- Nursing, cardiac rehabilitation, health promotion model, healthy lifestyle behaviors, health fatalism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology-based training structured according to the Health Promotion ModelOther
Experimental group: A video recording was created with a total of 6 zoom applications to be shared with the patients. The content of the video recordings consists of a presentation accompanied by a slide show with open-ended questions prepared by considering the basic concepts of the trainings and the Health Promotion Model. Video recordings, each of which lasted approximately 15-25 minutes, were shared with patients once a week for a total of 6 weeks via WhatsApp. After each video, patients were given three days to watch the video recordings and create their own responses. After this three-day period, the researcher called the patients with whom he shared the content and gave counseling for 10-15 minutes and received feedback. Follow-up was done in the second 6-week period. During the monitoring process, two reminder interviews were made over the phone, with an interval of 2 weeks, for reminder and counseling, and the post-test data were collected at the end of the monitoring period.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Other: Technology-based training structured according to the Health Promotion Model |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in healthy lifestyle behaviors score
Increase in healthy lifestyle behaviors score
Measured: 12 weeks
Change in health fatalism score
Decrease in health fatalism score
Measured: 12 weeks
Change in cardiovascular disease risk knowledge level score
Increase in cardiovascular disease risk knowledge level score
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start15 Apr 2022
- Primary completion15 Jun 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Have a Diagnosis of Coronary Artery DiseaseStudies 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
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hatice Karabulak
- Sponsor type
- University, hospital or other
- Collaborators
- Ataturk University
- Responsible party
- Sponsor-investigator, Hatice Karabulak, Ataturk University
- Investigators
- Prof.Dr.Canturk Capik, Study director, Ataturk University, Department of Public Health Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05980364
- Sponsor's protocol ID
- 02/60
- Status last verified
- Jul 2023
- First submitted
- 29 Jul 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Cardiac Rehabilitation The Effect of Technology-Based Education Structured According to the Health Promotion Model on Healthy Lifestyle Behaviors, Health Fatalism and Risk Knowledge Level: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05980364
- Acronym / sponsor ID
- 02/60
- Keywords
- Nursing, cardiac rehabilitation, health promotion model, healthy lifestyle behaviors, health fatalism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Hatice KarabulakUniversity, hospital or other
- Collaborators
- Ataturk University
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 8 Aug 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.
Cardiac rehabilitation is approaches that focus on accelerating the recovery process of patients after a cardiac event, improving their physical, psychological and social conditions, and controlling risk factors. Cardiac rehabilitation is known to be an effective and cost-effective approach in the secondary prevention of cardiovascular diseases, most of which are caused by preventable risks. Ischemic heart diseases, one of the cardiovascular diseases, are responsible for 16% of total deaths in the world and have increased significantly since 2000, causing 8.9 million deaths in 2019.
When coronary artery diseases cannot be prevented, the basic approach should be to ensure the individual's compliance with treatment and healthy lifestyle behaviors, and to increase the quality of life and life span.
For this reason, the aim of the study is to examine the effects of technology-based education structured according to the health promotion model in cardiac rehabilitation on healthy lifestyle behaviors, health fatalism and risk knowledge level.
Question 1. Does technology-based education structured according to the health promotion model affect the healthy lifestyle behaviors score? Question 2. Does technology-based education structured according to the health promotion model affect the health fatalism score? Question 3. Does technology-based education structured according to the health promotion model affect the cardiovascular disease risk factors knowledge level score?
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Technology-based training structured according to the Health Promotion Model |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Having a diagnosis of coronary artery disease (acute coronary syndrome, coronary revascularization, atherosclerotic heart disease, etc.),
- Being stable in health (the patient's health status does not change suddenly and is under control),
- If an interventional procedure has been performed, at least three months have passed after discharge,
- Being between the ages of 18-65,
- Being literate,
Key exclusion criteria (3 listed)
- Having a disability (vision, hearing, neurological, cognitive, etc.) that may interfere with education,
- Cardiac rehabilitation is contraindicated
- To have participated in a cardiac rehabilitation program given by another institution before or during the study,
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 |
|---|---|---|
| Technology-based training structured according to the Health Promotion ModelExperimental group: A video recording was created with a total of 6 zoom applications to be shared with the patients. The content of the video recordings consists of a presentation accompanied by a slide show with open-ended questions prepared by considering the basic concepts of the trainings and the Health Promotion Model. Video recordings, each of which lasted approximately 15-25 minutes, were shared with patients once a week for a total of 6 weeks via WhatsApp. After each video, patients were given three days to watch the video recordings and create their own responses. After this three-day period, the researcher called the patients with whom he shared the content and gave counseling for 10-15 minutes and received feedback. Follow-up was done in the second 6-week period. During the monitoring process, two reminder interviews were made over the phone, with an interval of 2 weeks, for reminder and counseling, and the post-test data were collected at the end of the monitoring period. | Other | Experimental group |
Primary outcome
Change in healthy lifestyle behaviors score
Time frame: 12 weeks
Increase in healthy lifestyle behaviors score
Change in health fatalism score
Time frame: 12 weeks
Decrease in health fatalism score
Change in cardiovascular disease risk knowledge level score
Time frame: 12 weeks
Increase in cardiovascular disease risk knowledge level score
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 8 Aug 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.
Prof.Dr.Canturk Capik study director
Ataturk University, Department of Public Health Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology-based training structured according to the Health Promotion Model in people with Have a Diagnosis of Coronary Artery Disease, run by Hatice Karabulak 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 7 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 8 Aug 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?
Change in healthy lifestyle behaviors score (time frame: 12 weeks). 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 8 Aug 2023.