Cardiac RehabilitationNCT05489913
Web Based Cardiac Rehabilitation Support in Coronary Artery Patients
A study testing cardiac rehabilitation support program in people with Cardiac Rehabilitation and Healthy Lifestyle, run by Semiha ALKAN KAYHAN at 1 site in Turkey (Türkiye).
Trial summary
This study was carried out as a randomized controlled experimental study to evaluate the effect of web-based cardiac rehabilitation support on the healthy lifestyle behaviors, medication adherence and quality of life in coronary heart patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Rehabilitation, Healthy Lifestyle, Medication Adherence
- What is being tested?
- cardiac rehabilitation support program
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2020to 30 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of Coronary artery disease, adult patients, those for whom no surgical operation was planned, those who were clinically stable, those who were literate, those who could communicate verbally, use the Internet, those who had a computer, tablet or smartphone, and those who agreed to participate in the study.
Who cannot join
- Those who have a disease that is not suitable for the CR program, those who did not agree to participate in the study, those who did not log in after registering on the website, did not read the trainings and could not communicate with the patient during the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health Science University Ahi Evren thoracic and cardiovascular surgery training and research hospital
Trabzon, 61100
About this study
Official title: The Effect of Web Based Cardiac Rehabilitation Support on the Healthy Lifestyle Behaviors, Medication Adherence and Quality of Life in Coronary Artery Patients
This study was carried out as a randomized controlled experimental study to evaluate the effect of web-based cardiac rehabilitation support on the healthy lifestyle behaviors, medication adherence and quality of life in coronary heart patients.
Read the detailed description
Hypothesis 1:
H0: Web-based cardiac rehabilitation support has no effect on increasing the healthy lifestyle behaviors of patients with coronary artery disease.
H1: Web-based cardiac rehabilitation support has an effect on increasing the healthy lifestyle behaviors of patients with coronary artery disease.
Hypothesis 2:
H0: Web-based cardiac rehabilitation support in patients with coronary artery disease has no effect on increasing the compliance of patients to drug therapy.
H1: Web-based cardiac rehabilitation support in patients with coronary artery disease has an effect on increasing the compliance of patients to drug therapy.
Hypothesis 3:
H0: Web-based cardiac rehabilitation support has no effect on improving the quality of life of patients with coronary artery disease.
H1: Web-based cardiac rehabilitation support has an effect on improving the quality of life of patients with coronary artery disease.
- Conditions
- Cardiac Rehabilitation, Healthy Lifestyle, Medication Adherence, Quality of Life, Coronary Artery Disease
- Being tested
- cardiac rehabilitation support program
- Medical subject headings
- Medication Adherence, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac rehabilitation support programOther
First of all, a preliminary interview was made with the patients in the experimental group, and their information needs were evaluated individually. Which trainings he should receive and his priorities were determined with the patient. After the training requirements were determined, the general introduction of the website was made and they were allowed to register. Experimental group patients received both training on the website and counseling over the phone for 12 weeks after they started working. A total of 3 phone calls were made with the patients in the first week, 4th and 8th weeks. The interviews lasted an average of 20 minutes. In each phone call, patients were informed and reminded. When patients needed, an average of 2-3 more phone calls were made and information was provided on the subjects they needed.
| Study group | Role | What they receive |
|---|---|---|
| Web based Cardiac Rehabilitation program and follow-up telephone | Experimental | The website was created under the name of "Cardiac Rehabilitation Support Program". The language of the website is Turkish. Designed for computer, tablet and mobile phone use. Patients must be registered to access the website. After creating a six-digit password during registration, they log in to the website with their e-mail address and this password. The password is determined specifically for the patient. There is a welcome text on the home page of the website. The main headings in the menu section; trainings, disease management questions, questionnaires, ask questions to the researcher. Receives: Other: cardiac rehabilitation support program |
| Standard care | No intervention | patients received their training before discharge from the hospital and no intervention was made for 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the total and sub-dimension total scores of the healthy lifestyle behaviors scale of the patients in the experimental and control groups
Healthy Lifestyle Behaviors Scale II: The scale has 52 items and six factors.The lowest score obtained from the scale is 52, and the highest score is 208.Healthy lifestyle behaviors score is obtained from the overall score of the scale.High scores obtained from the scale indicate a high level of healthy lifestyle behaviors.
Measured: twelve weeks
Comparison of experimental and control group patients' compliance with medication adherence
Medication Adherence Questions:
There are three questions in order to evaluate the patients' compliance with drug therapy. These; It consists of questions such as "Do you have problems remembering to take your medicine regularly, do you stop taking your medicine without your doctor's advice when your complaints subside/end, if you don't feel well when you take your medicine (side effects etc.) do you stop taking your medicine?"
Measured: twelve weeks
Comparison of general quality of life scale index and general quality of life scale vas scores of experimental and control group patients
EQ-5D General Quality of Life Scale: It was developed by the Western European Quality of Life Research Society. It consists of five dimensions. In these five dimensions; mobility and walking or walking, doing daily activities with normal daily activities, feeling of pain/discomfort and anxiety/depression and feeling anxious, etc. are evaluated. For the answers given to each dimension, there is no problem, there is some problem, and major problem options are included. A score between -0.59 and 1 is calculated from the five dimensions of the scale. A value of 0 is death, a value of 1 is perfect health, negative values are unconscious and bedridden, etc. points to the results. The scale also includes an easily understandable version of the rated Visual Analog Scale (VAS). Here, participants rate their overall health status from 0 to 100. A score of 100 represents the best health imaginable, while 0 represents the worst.
Measured: twelve weeks
Comparison of international physical activity questionnaire total scores and physical activity levels of experimental and control group patients
International Physical Activity Questionnaire-Short Form: In the scale, walking for at least 10 minutes in the last 7 days, moderate-intensity and intense activities, and sedentary time spent in an average day are asked and metabolic equivalent (MET) scores are calculated. Total time (minutes) and frequency (days) are required to calculate the score. Results are evaluated in three categories: low level, intermediate level and high level. The low level is evaluated as <600 MET, the intermediate level 600-3000 MET, and the high level >3000 MET. The acceptable value in terms of health is expressed as intermediate level, ie 600-3000 MET.
Measured: twelve weeks
Comparison of body mass index values of experimental and control group patients
The formula used to calculate the body mass index is as follows: height (cm)/weight (kg)*weight (kg). After calculating the body mass index of each patient according to this formula, the data were compared.
Measured: twelve weeks
Comparison of LDL values of experimental and control group patients
Measured: twelve weeks
Comparison of smoking status of experimental and control group patients
In the patient information form, patients were asked whether they smoked or not.
Measured: twelve weeks
Post-test Computer System Usability Questionaire Short Version total and sub-dimension scores of the experimental group patients
Availability of a computer system; system usefulness (items 1-6), information quality (items 7-9), and interface dimensions (items 10-12) with 13 items. Each item is scored as 1 (strongly agree) and 7 (strongly disagree). The scale was set up in reverse, and low scores indicate good usability of the system.
Measured: twelve weeks
Comparison of triglyceride values of experimental and control group patients
Measured: twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start1 Mar 2020
- Primary completion1 May 2020
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac RehabilitationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semiha ALKAN KAYHAN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Semiha ALKAN KAYHAN, Karadeniz Technical University
- Investigators
- Semiha ALKAN KAYHAN, Principal investigator, ahi Evren thoracic and cardiovascular surgery training and research hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05489913
- Sponsor's protocol ID
- 24237859-534
- Status last verified
- Oct 2023
- First submitted
- 1 Aug 2022
- Last updated
- 4 Oct 2023
- Results posted
- 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 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Web Based Cardiac Rehabilitation Support on the Healthy Lifestyle Behaviors, Medication Adherence and Quality of Life in Coronary Artery Patients
- ClinicalTrials.gov ID
- NCT05489913
- Acronym / sponsor ID
- 24237859-534
- Conditions
- Cardiac Rehabilitation, Healthy Lifestyle, Medication Adherence, Quality of Life, Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Semiha ALKAN KAYHANUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 5 Aug 2022 (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 carried out as a randomized controlled experimental study to evaluate the effect of web-based cardiac rehabilitation support on the healthy lifestyle behaviors, medication adherence and quality of life in coronary heart patients.
Detailed description
Hypothesis 1:
H0: Web-based cardiac rehabilitation support has no effect on increasing the healthy lifestyle behaviors of patients with coronary artery disease.
H1: Web-based cardiac rehabilitation support has an effect on increasing the healthy lifestyle behaviors of patients with coronary artery disease.
Hypothesis 2:
H0: Web-based cardiac rehabilitation support in patients with coronary artery disease has no effect on increasing the compliance of patients to drug therapy.
H1: Web-based cardiac rehabilitation support in patients with coronary artery disease has an effect on increasing the compliance of patients to drug therapy.
Hypothesis 3:
H0: Web-based cardiac rehabilitation support has no effect on improving the quality of life of patients with coronary artery disease.
H1: Web-based cardiac rehabilitation support has an effect on improving the quality of life of patients with coronary artery disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web based Cardiac Rehabilitation program and follow-up telephone | Experimental | Other: cardiac rehabilitation support programThe website was created under the name of "Cardiac Rehabilitation Support Program". The language of the website is Turkish. Designed for computer, tablet and mobile phone use. Patients must be registered to access the website. After creating a six-digit password during registration, they log in to the website with their e-mail address and this password. The password is determined specifically for the patient. There is a welcome text on the home page of the website. The main headings in the menu section; trainings, disease management questions, questionnaires, ask questions to the researcher. |
| Standard care | No intervention | –patients received their training before discharge from the hospital and no intervention was made for 12 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with a diagnosis of Coronary artery disease, adult patients, those for whom no surgical operation was planned, those who were clinically stable, those who were literate, those who could communicate verbally, use the Internet, those who had a computer, tablet or smartphone, and those who agreed to participate in the study.
Key exclusion criteria (1 listed)
- Those who have a disease that is not suitable for the CR program, those who did not agree to participate in the study, those who did not log in after registering on the website, did not read the trainings and could not communicate with the patient 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 |
|---|---|---|
| cardiac rehabilitation support programFirst of all, a preliminary interview was made with the patients in the experimental group, and their information needs were evaluated individually. Which trainings he should receive and his priorities were determined with the patient. After the training requirements were determined, the general introduction of the website was made and they were allowed to register. Experimental group patients received both training on the website and counseling over the phone for 12 weeks after they started working. A total of 3 phone calls were made with the patients in the first week, 4th and 8th weeks. The interviews lasted an average of 20 minutes. In each phone call, patients were informed and reminded. When patients needed, an average of 2-3 more phone calls were made and information was provided on the subjects they needed. | Other | Web based Cardiac Rehabilitation program and follow-up telephone |
Primary outcome
Comparison of the total and sub-dimension total scores of the healthy lifestyle behaviors scale of the patients in the experimental and control groups
Time frame: twelve weeks
Healthy Lifestyle Behaviors Scale II: The scale has 52 items and six factors.The lowest score obtained from the scale is 52, and the highest score is 208.Healthy lifestyle behaviors score is obtained from the overall score of the scale.High scores obtained from the scale indicate a high level of healthy lifestyle behaviors.
Comparison of experimental and control group patients' compliance with medication adherence
Time frame: twelve weeks
Medication Adherence Questions: There are three questions in order to evaluate the patients' compliance with drug therapy. These; It consists of questions such as "Do you have problems remembering to take your medicine regularly, do you stop taking your medicine without your doctor's advice when your complaints subside/end, if you don't feel well when you take your medicine (side effects etc.) do you stop taking your medicine?"
Comparison of general quality of life scale index and general quality of life scale vas scores of experimental and control group patients
Time frame: twelve weeks
EQ-5D General Quality of Life Scale: It was developed by the Western European Quality of Life Research Society. It consists of five dimensions. In these five dimensions; mobility and walking or walking, doing daily activities with normal daily activities, feeling of pain/discomfort and anxiety/depression and feeling anxious, etc. are evaluated. For the answers given to each dimension, there is no problem, there is some problem, and major problem options are included. A score between -0.59 and 1 is calculated from the five dimensions of the scale. A value of 0 is death, a value of 1 is perfect health, negative values are unconscious and bedridden, etc. points to the results. The scale also includes an easily understandable version of the rated Visual Analog Scale (VAS). Here, participants rate their overall health status from 0 to 100. A score of 100 represents the best health imaginable, while 0 represents the worst.
Comparison of international physical activity questionnaire total scores and physical activity levels of experimental and control group patients
Time frame: twelve weeks
International Physical Activity Questionnaire-Short Form: In the scale, walking for at least 10 minutes in the last 7 days, moderate-intensity and intense activities, and sedentary time spent in an average day are asked and metabolic equivalent (MET) scores are calculated. Total time (minutes) and frequency (days) are required to calculate the score. Results are evaluated in three categories: low level, intermediate level and high level. The low level is evaluated as <600 MET, the intermediate level 600-3000 MET, and the high level >3000 MET. The acceptable value in terms of health is expressed as intermediate level, ie 600-3000 MET.
Comparison of body mass index values of experimental and control group patients
Time frame: twelve weeks
The formula used to calculate the body mass index is as follows: height (cm)/weight (kg)*weight (kg). After calculating the body mass index of each patient according to this formula, the data were compared.
Comparison of LDL values of experimental and control group patients
Time frame: twelve weeks
Comparison of smoking status of experimental and control group patients
Time frame: twelve weeks
In the patient information form, patients were asked whether they smoked or not.
Post-test Computer System Usability Questionaire Short Version total and sub-dimension scores of the experimental group patients
Time frame: twelve weeks
Availability of a computer system; system usefulness (items 1-6), information quality (items 7-9), and interface dimensions (items 10-12) with 13 items. Each item is scored as 1 (strongly agree) and 7 (strongly disagree). The scale was set up in reverse, and low scores indicate good usability of the system.
Comparison of triglyceride values of experimental and control group patients
Time frame: twelve weeks
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 4 Oct 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.
Semiha ALKAN KAYHAN principal investigator
ahi Evren thoracic and cardiovascular surgery training and research hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cardiac rehabilitation support program in people with Cardiac Rehabilitation and Healthy Lifestyle, run by Semiha ALKAN KAYHAN 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 1 inclusion and 1 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 4 Oct 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?
Comparison of the total and sub-dimension total scores of the healthy lifestyle behaviors scale of the patients in the experimental and control groups (time frame: twelve weeks). The study lists 9 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 4 Oct 2023.