Decision MakingNCT04723329
The Effect of Web-based Training on Gaining Exercise Behavior in Coronary Artery Patients
A study testing Web-based exercise training based on the transtheoretic model in people with Decision Making and Exercise, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this thesis is; The aim of this study is to examine the effect of web-based training based on transtheoretic model on exercise behavior in patients with coronary artery disease. The research is a randomized controlled trial. 114 patient who meet the conditions for research will be included in the study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Decision Making, Exercise, Self Efficacy
- What is being tested?
- Web-based exercise training based on the transtheoretic model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2021to May 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
- Being literate
- Having internet access and using it comfortably, Independent in daily life activities
Who cannot join
- Have any physical and psychological problems that prevent exercising
- Those who do not intend to exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lecturer at Cumhuriyet University
The aim of this thesis is; The aim of this study is to examine the effect of web-based training based on transtheoretic model on exercise behavior in patients with coronary artery disease.
The research is a randomized controlled trial. 114 patient who meet the conditions for research will be included in the study. In collecting data, the Patient Information Form, Exercise Change Phase Short Question Form, Exercise Change Processes Scale, Exercise Decision Making Scale and Exercise Self-Efficacy Scale developed by the researcher will be used.
Read the detailed description
In the first interview, the patients in the experimental group will be collected data and contact information will be obtained using the Patient Information Form, Exercise Change Phase Short Question Form, Exercise Change Processes Scale, Exercise Decision Making Balance Scale and Exercise Self-Efficacy Scale as a pre-test. Then, the patients will be given their username and password to log into the website. The change stage of the patients will be determined by the researcher with the Exercise Change Phase Short Question Form, and it will be ensured that they reach the educational content prepared according to the transtheoretic model. Motivating interviews will be provided for the patients to receive training on the website by contacting them one-on-one. In the following 1st and 3rd months, the patients will be contacted individually again to confirm whether they follow the website, and they will be asked to fill the scales on the website by providing consultancy on the issues they need. In the 6th month, the final test data will be obtained from the website using the same data collection forms.
The patients in the control group will be collected data and contact information will be obtained at the first interview using the Patient Information Form, Exercise Change Phase Short Question Form, Change Processes Scale, Decision Making Balance Scale and Self-Efficacy Scale. Later, patients will be given their username and password so that they can log into the website where the scales are located in order to apply the final test. No intervention will be applied to the patients in the control group. At the end of the 6th month, the same scales will be applied on the website as a final test. At the end of the study, the patients in the control group will be able to access the exercise training content prepared for the purpose of gaining exercise behavior on the website.
Nursing Initiative The patients in the experimental group will be given a web-based exercise training based on the transtheoretic model according to the stages of change they are in.
Interference Material As the initiative material, the participants; A website will be established where they can log in with an individually given username and password. As the content; The harms of sedentary life, the benefits of exercise on general health, especially its effects on reducing heart diseases and risks, and materials for gaining exercise behavior will be included.
- Conditions
- Decision Making, Exercise, Self Efficacy
- Being tested
- Web-based exercise training based on the transtheoretic model
- Keywords
- Exercise, web-based education, Patients
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based exercise training based on the transtheoretic modelBehavioural
Motivating interviews will be provided to the patients to receive training on the website by contacting them one-on-one. In the following 1st and 3rd months, patients will be contacted individually again to confirm whether they follow the website, and they will be asked to fill in the scales on the website by providing consultancy on the issues they need. In the 6th month, the final test data will be obtained from the website using the same data collection forms.
| Study group | Role | What they receive |
|---|---|---|
| web-based education group | Experimental | Patients will be given a username and password to access the website. The change stage of the patients will be determined by the researcher with the Exercise Change Phase Short Question Form, and it will be ensured that they reach the educational content prepared according to the transtheoretic model. Motivating interviews will be provided to the patients to receive training on the website by contacting them one-on-one. In the following 1st and 3rd months, patients will be contacted individually again to confirm whether they follow the website, and they will be asked to fill in the scales on the website by providing consultancy on the issues they need. In the 6th month, the final test data will be obtained from the website using the same data collection forms. Receives: Behavioral: Web-based exercise training based on the transtheoretic model |
| Control Group | No intervention | In the first interview, the patients in the control group will be collected data and contact information will be obtained using the Patient Information Form, Exercise Change Phase Short Question Form, Change Processes Scale, Decision Making Balance Scale and Self-Efficacy Scale. Later, patients will be given their username and password so that they can log into the website where the scales are located in order to apply the final test. No intervention will be applied to the patients in the control group. At the end of the 6th month, the same scales will be applied on the website as a final test. At the end of the study, it is aimed to gain exercise behavior to the patients in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Change Stage
Exercise Change Stage Short Question Form is an 5 item scale. 1=Exercising regularly for more than 6 months, 2=Exercising regularly for less than 6 months, 3=Does not exercise but intends to do it within 30 days, 4=Does not exercising but intends to start within 6 months, 5=Does not exercise and does not intend to start within 6 months
Measured: up to 6 months
Exercise Change Processes Scale
Change Processes Scale is an 28 item scale.Individuals in the scale do not agree with each statement using a 5-point Likert scale. is determined. Each individual in scale how much to exercise in the condition stated in item he often does a It is determined by the grading score. From the interviewee, the items of this scale by reading "1 = never" for each item, "2 = rarely", "3 = occasionally", "4 = often", "5 very often" the most suitable for him He is asked to select and mark the one. Scale, item points of all subscales score obtained from averages It is evaluated according to the average.There are cognitive and behavioral processes that facilitate change in the Exercise Change Processes Scale. The overall Cronbach's alpha coefficient of the scale is 0.95, and it was determined as 0.91 for cognitive processes with sub-dimensions and 0.93 for behavioral processes.
Measured: up to 6 months
Exercise Decision-Making Balance
Change Processes Scale is an 10 item scale. Total score of the scale, the perceived benefit of exercising is total of the total score of perceived damage It is obtained by subtraction. Your result negative (-), in decision-making balance the perceived harms of exercise dominant, positive (+), decision exercising in a giving balance a sign that the perceived benefits are dominant does. The highest score that can be obtained from the scale 25 is the lowest score is 5.
Measured: up to 6 months
Exercise Self-Efficacy Scale
Self-Efficacy Scale is an 6 item scale.From scale the highest score an individual can get is 30, low score is 6. In the evaluation of the scale; The higher the item score average, the higher the individual's selfishness.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study startFeb 2021 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decision MakingStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Unver, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04723329
- Sponsor's protocol ID
- Inonu University
- Status last verified
- Jan 2021
- First submitted
- 13 Jan 2021
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lecturer at Cumhuriyet University
- ClinicalTrials.gov ID
- NCT04723329
- Acronym / sponsor ID
- Inonu University
- Conditions
- Decision Making, Exercise, Self Efficacy
- Keywords
- Exercise, web-based education, Patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- Feb 2021 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 25 Jan 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 aim of this thesis is; The aim of this study is to examine the effect of web-based training based on transtheoretic model on exercise behavior in patients with coronary artery disease.
The research is a randomized controlled trial. 114 patient who meet the conditions for research will be included in the study. In collecting data, the Patient Information Form, Exercise Change Phase Short Question Form, Exercise Change Processes Scale, Exercise Decision Making Scale and Exercise Self-Efficacy Scale developed by the researcher will be used.
Detailed description
In the first interview, the patients in the experimental group will be collected data and contact information will be obtained using the Patient Information Form, Exercise Change Phase Short Question Form, Exercise Change Processes Scale, Exercise Decision Making Balance Scale and Exercise Self-Efficacy Scale as a pre-test. Then, the patients will be given their username and password to log into the website. The change stage of the patients will be determined by the researcher with the Exercise Change Phase Short Question Form, and it will be ensured that they reach the educational content prepared according to the transtheoretic model. Motivating interviews will be provided for the patients to receive training on the website by contacting them one-on-one. In the following 1st and 3rd months, the patients will be contacted individually again to confirm whether they follow the website, and they will be asked to fill the scales on the website by providing consultancy on the issues they need. In the 6th month, the final test data will be obtained from the website using the same data collection forms.
The patients in the control group will be collected data and contact information will be obtained at the first interview using the Patient Information Form, Exercise Change Phase Short Question Form, Change Processes Scale, Decision Making Balance Scale and Self-Efficacy Scale. Later, patients will be given their username and password so that they can log into the website where the scales are located in order to apply the final test. No intervention will be applied to the patients in the control group. At the end of the 6th month, the same scales will be applied on the website as a final test. At the end of the study, the patients in the control group will be able to access the exercise training content prepared for the purpose of gaining exercise behavior on the website.
Nursing Initiative The patients in the experimental group will be given a web-based exercise training based on the transtheoretic model according to the stages of change they are in.
Interference Material As the initiative material, the participants; A website will be established where they can log in with an individually given username and password. As the content; The harms of sedentary life, the benefits of exercise on general health, especially its effects on reducing heart diseases and risks, and materials for gaining exercise behavior will be included.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| web-based education group | Experimental | Behavioral: Web-based exercise training based on the transtheoretic modelPatients will be given a username and password to access the website. The change stage of the patients will be determined by the researcher with the Exercise Change Phase Short Question Form, and it will be ensured that they reach the educational content prepared according to the transtheoretic model. Motivating interviews will be provided to the patients to receive training on the website by contacting them one-on-one. In the following 1st and 3rd months, patients will be contacted individually again to confirm whether they follow the website, and they will be asked to fill in the scales on the website by providing consultancy on the issues they need. In the 6th month, the final test data will be obtained from the website using the same data collection forms. |
| Control Group | No intervention | –In the first interview, the patients in the control group will be collected data and contact information will be obtained using the Patient Information Form, Exercise Change Phase Short Question Form, Change Processes Scale, Decision Making Balance Scale and Self-Efficacy Scale. Later, patients will be given their username and password so that they can log into the website where the scales are located in order to apply the final test. No intervention will be applied to the patients in the control group. At the end of the 6th month, the same scales will be applied on the website as a final test. At the end of the study, it is aimed to gain exercise behavior to the patients in the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being literate
- Having internet access and using it comfortably, Independent in daily life activities
Key exclusion criteria (2 listed)
- Have any physical and psychological problems that prevent exercising
- Those who do not intend to exercise
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 |
|---|---|---|
| Web-based exercise training based on the transtheoretic modelMotivating interviews will be provided to the patients to receive training on the website by contacting them one-on-one. In the following 1st and 3rd months, patients will be contacted individually again to confirm whether they follow the website, and they will be asked to fill in the scales on the website by providing consultancy on the issues they need. In the 6th month, the final test data will be obtained from the website using the same data collection forms. | Behavioural | web-based education group |
Primary outcome
Exercise Change Stage
Time frame: up to 6 months
Exercise Change Stage Short Question Form is an 5 item scale. 1=Exercising regularly for more than 6 months, 2=Exercising regularly for less than 6 months, 3=Does not exercise but intends to do it within 30 days, 4=Does not exercising but intends to start within 6 months, 5=Does not exercise and does not intend to start within 6 months
Exercise Change Processes Scale
Time frame: up to 6 months
Change Processes Scale is an 28 item scale.Individuals in the scale do not agree with each statement using a 5-point Likert scale. is determined. Each individual in scale how much to exercise in the condition stated in item he often does a It is determined by the grading score. From the interviewee, the items of this scale by reading "1 = never" for each item, "2 = rarely", "3 = occasionally", "4 = often", "5 very often" the most suitable for him He is asked to select and mark the one. Scale, item points of all subscales score obtained from averages It is evaluated according to the average.There are cognitive and behavioral processes that facilitate change in the Exercise Change Processes Scale. The overall Cronbach's alpha coefficient of the scale is 0.95, and it was determined as 0.91 for cognitive processes with sub-dimensions and 0.93 for behavioral processes.
Exercise Decision-Making Balance
Time frame: up to 6 months
Change Processes Scale is an 10 item scale. Total score of the scale, the perceived benefit of exercising is total of the total score of perceived damage It is obtained by subtraction. Your result negative (-), in decision-making balance the perceived harms of exercise dominant, positive (+), decision exercising in a giving balance a sign that the perceived benefits are dominant does. The highest score that can be obtained from the scale 25 is the lowest score is 5.
Exercise Self-Efficacy Scale
Time frame: up to 6 months
Self-Efficacy Scale is an 6 item scale.From scale the highest score an individual can get is 30, low score is 6. In the evaluation of the scale; The higher the item score average, the higher the individual's selfishness.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
Related trials for Decision Making
RecruitingEarly Phase 1
Developing Transcranial Neuromodulation Protocols for Learning and Decision-Making
Normal Physiology
Recruiting
Patient Priorities Aligned Discrete Decision Making for Older Adults With Multiple Chronic Conditions.
Hernia
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Active, not recruiting
Developing and Testing an Online Pathway From Screening to Treatment for Depression in Oncology: iPath*D (Aim 2)
Cancer, Depression
Not yet recruiting
A Multidimensional Intervention to Improve Ethical Decision-Making Competence Among Nursing Student Interns: A Randomized Controlled Trial
Ethical Decision-Making Competence in Nursing Student Interns
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 Web-based exercise training based on the transtheoretic model in people with Decision Making and Exercise, run by Cumhuriyet 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 25 Jan 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 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?
Results are not available in the source record.
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 Change Stage (time frame: up to 6 months). The study lists 4 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 25 Jan 2021.