Cardiovascular DiseasesNCT06537856
Impact of Education and Text Messages on Cardiovascular Disease Risk Factors Awareness Knowledge and Quality of Life
A study testing Health Belief Model Based Cardiovascular Disease Risk Factor Prevention Education and Reminder Short Messages in people with Cardiovascular Diseases, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to evaluate the effect of a health education program based on the health belief model and text messages on the level of knowledge, awareness and quality of life regarding cardiovascular disease risk factors in firefighters. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Health Belief Model Based Cardiovascular Disease Risk Factor Prevention Education and Reminder Short Messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Dec 2023to 5 May 2024
- 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
- Over 18 years of age,
- No reading and comprehension problems,
- Individuals who agreed to participate in the study,
- Not having any cardiovascular disease,
- To be working in the institution where the research is carried out,
- Not having any mental illness or a disease/disabily that would prevent working ,
- Not having any structured training in preventing cardiovascular disease.
Who cannot join
- Under 18,
- Having cardiovascular disease,
- Refuses to work or wants to leave during the work,
- Individuals with reading and comprehension problems,
- To have received any training on cardiovascular disease prevention,
- Having any mental illness or disease/disability that would prevent participation in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Aljazari International School of Science and Technology
Istanbul, Atakent, 34307
About this study
Official title: The Effect of Health Education Based on Health Belief Model and Text Messages Given to Firefighters on The Level of Knowledge, Awareness and Quality Of Life About Cardiovascular Disease Risk Factors
This study was planned to evaluate the effect of a health education program based on the health belief model and text messages on the level of knowledge, awareness and quality of life regarding cardiovascular disease risk factors in firefighters. A total of 160 firefighters, 84 in the intervention group and 76 in the control group, constituted the sample of the study.
Hypotheses of the Study H1 The mean CDRAAS posttest scores of the firefighters in the intervention group after health education will be higher than the mean posttest scores of the control group.
Read more
H2 The mean CDRAAS post-test scores of the firefighters in the intervention group after the health education will be higher than the mean pre-test scores.
H3 The mean CARRIF-KL posttest scores of the firefighters in the intervention group after health education will be higher than the mean posttest scores of the control group.
H4 The mean CARRIF-KL posttest scores of the firefighters in the intervention group after the health education will be higher than the mean pretest scores.
H5 The mean EQ-5D posttest scores of the firefighters in the intervention group after health education will be higher than the mean posttest scores of the control group.
H6 The mean EQ-5D posttest scores of the firefighters in the intervention group after health education will be higher than the mean pretest scores.
Read the detailed description
In this study, a randomized control group pretest-posttest design was used to evaluate the effect of a health education program based on the health belief model and text messages on the level of knowledge, awareness and quality of life regarding cardiovascular disease risk factors in firefighters.
The power analysis was applied based on a 5% significance level (or 95% confidence interval), two-way, 80% power requirement. As a result of the analysis, the minimum sample size required for each group (intervention and control) in the study was calculated as 67 people. The intervention group received health education on prevention of cardiovascular disease risk factors based on the Health Belief Model consisting of 3 sessions. Following the health education, a total of 39 reminder text messages were sent via WhatsApp three or four times a week for 12 weeks to increase self-efficacy and health motivation. Data were collected through face-to-face interviews and by using the Cardiovascular Disease Risk Awareness Rating Scale, the Cardiovascular Disease Risk Factor Knowledge Level Scale and the EQ-5D Quality of Life Scale. In data analysis, dependent samples t test (paired samples t test) was used for intra-group mean comparisons and independent samples t test (independent samples t test) was used for inter-group mean comparisons.
- Conditions
- Cardiovascular Diseases
- Being tested
- Health Belief Model Based Cardiovascular Disease Risk Factor Prevention Education, Reminder Short Messages
- Keywords
- Health Belief Model, Firefighter, Occupational Health Nursing, Cardiovascular disease, Risk Factors, Health Education
- Medical subject headings
- Cardiovascular Diseases, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Belief Model Based Cardiovascular Disease Risk Factor Prevention EducationOther
Also called Reminder Short Messages
In line with the literature review, "Health Belief Model-Based Cardiovascular Disease Risk Factor Prevention Training" was created in order to increase the level of knowledge of firefighters regarding cardiovascular disease risk factors, improve their awareness and positively affect their quality of life. This training was given in 3 different sessions by meeting face-to-face with firefighters in the training hall of the fire stations. Each session lasted 40 minutes. Answers were given to the questions asked at the end of the session. The training was organized under the following main headings:
Perceived Sensitivity, Perceived Seriousness, Perceived Barriers, Perceived Self-Efficacy, Health Motivation/Activators
Reminder Short MessagesBehavioural
After the Health Belief Model-Based health education, 39 text messages were sent via WhatsApp application 3-4 times a week for 3 months to increase the effectiveness of the education and the motivation of firefighters in CVD prevention.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Prior to the intervention, both the control and intervention groups were interviewed face-to-face and completed the Cardiovascular Disease Risk Awareness Rating Scale (CDRAAS), the Cardiovascular Disease Risk Factor Knowledge Level Scale (CARRF-KL) and the EQ-5D Quality of Life Scale. The intervention group then received health belief model-based cardiovascular disease risk factor prevention training. This training, conducted by the researcher, was carried out in 3 sessions, including interactive question-answer sessions. After the training, a total of 39 reminder text messages were sent to the intervention group via WhatsApp 2-3 times a week for 12 weeks. Receives: Other: Health Belief Model Based Cardiovascular Disease Risk Factor Prevention Education; Behavioral: Reminder Short Messages |
| No intervention | No intervention | No intervention was given to the control group. After the education given to the intervention group and the reminder text messages sent for 12 weeks, the intervention and control groups were asked to fill out the Cardiovascular Disease Risk Awareness Rating Scale (CDRAAS), Cardiovascular Disease Risk Factor Knowledge Level Scale (CARRF-KL) and EQ-5D Quality of Life Scale again in the same week. After the post-tests were taken, the control group also received training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular Disease Risk Awareness Assessment Scale (CDRAAS)
The scale consists of three sub-dimensions: perceived heart attack/stroke risk, perceived benefits and intentions to change, and healthy eating intentions. The scale, which consists of 22 items in total, is a 4-point Likert scale and is scored between 1 (strongly disagree) and 4 (strongly agree). Higher scale and subscale scores indicate increased awareness of cardiovascular diseases.
Measured: two weeks
Secondary outcomes (2)
The Cardiovascular Disease Risk Factors Knowledge Level (CARRF-KL)
The scale is used to measure the level of knowledge about cardiovascular disease risk factors. While the first four items in the scale are related to the characteristics of cardiovascular diseases, preventability and age factor, 15 items question risk factors and nine items question the result of change in risk behaviors. Scale items are answered with 'True', 'False' and 'Don't know' options. Each correct answer is scored as 1 point. Scores that can be obtained from the scale vary between 0 and 28, with the highest score being 28 and the lowest score being 0. The higher the score obtained from the scale, the higher the level of knowledge.
Measured: two weeks
EuroQol Quality of Life Scale
It is a quality of life scale that measures how individuals perceive and evaluate their own health status. The scale consists of two parts: EQ-5D Index and EQ-5D (Visual Analog Score (VAS). EQ-5D index: It consists of 5 dimensions: movement, pain, general activities, self-care, anxiety/depression. The answers to each dimension have 5 options: no problem, mild problem, moderate problem, severe problem and extreme problem. EQ-5D VAS: It is a visual analog scale in which individuals give values between 0 and 100 about their current health status and mark it on a thermometer-like scale. Quality of life scores ranging from 0 to 100 are obtained with the scale. An increase in the scale score indicates a positive perception of health.
Measured: two 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 2024
- Study start4 Dec 2023
- Primary completion15 Dec 2023
- Study completion5 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Model description
- In the study, there are two parallel groups as control and intervention groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehra Kartoğlu, Marmara University
- Investigators
- Zehra Kartoğlu, M.Sc Student, Principal investigator, zehra.kartoglu@aljazari.k12.tr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06537856
- Sponsor's protocol ID
- MU-HSI-ZK-01
- Status last verified
- Jul 2024
- First submitted
- 31 Jul 2024
- Last updated
- 5 Aug 2024
- 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 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Health Education Based on Health Belief Model and Text Messages Given to Firefighters on The Level of Knowledge, Awareness and Quality Of Life About Cardiovascular Disease Risk Factors
- ClinicalTrials.gov ID
- NCT06537856
- Acronym / sponsor ID
- MU-HSI-ZK-01
- Conditions
- Cardiovascular Diseases
- Keywords
- Health Belief Model, Firefighter, Occupational Health Nursing, Cardiovascular disease, Risk Factors, Health Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 5 May 2024 (actual)
- First posted
- 5 Aug 2024 (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 planned to evaluate the effect of a health education program based on the health belief model and text messages on the level of knowledge, awareness and quality of life regarding cardiovascular disease risk factors in firefighters. A total of 160 firefighters, 84 in the intervention group and 76 in the control group, constituted the sample of the study.
Hypotheses of the Study H1 The mean CDRAAS posttest scores of the firefighters in the intervention group after health education will be higher than the mean posttest scores of the control group.
H2 The mean CDRAAS post-test scores of the firefighters in the intervention group after the health education will be higher than the mean pre-test scores.
H3 The mean CARRIF-KL posttest scores of the firefighters in the intervention group after health education will be higher than the mean posttest scores of the control group.
H4 The mean CARRIF-KL posttest scores of the firefighters in the intervention group after the health education will be higher than the mean pretest scores.
H5 The mean EQ-5D posttest scores of the firefighters in the intervention group after health education will be higher than the mean posttest scores of the control group.
H6 The mean EQ-5D posttest scores of the firefighters in the intervention group after health education will be higher than the mean pretest scores.
Detailed description
In this study, a randomized control group pretest-posttest design was used to evaluate the effect of a health education program based on the health belief model and text messages on the level of knowledge, awareness and quality of life regarding cardiovascular disease risk factors in firefighters.
The power analysis was applied based on a 5% significance level (or 95% confidence interval), two-way, 80% power requirement. As a result of the analysis, the minimum sample size required for each group (intervention and control) in the study was calculated as 67 people. The intervention group received health education on prevention of cardiovascular disease risk factors based on the Health Belief Model consisting of 3 sessions. Following the health education, a total of 39 reminder text messages were sent via WhatsApp three or four times a week for 12 weeks to increase self-efficacy and health motivation. Data were collected through face-to-face interviews and by using the Cardiovascular Disease Risk Awareness Rating Scale, the Cardiovascular Disease Risk Factor Knowledge Level Scale and the EQ-5D Quality of Life Scale. In data analysis, dependent samples t test (paired samples t test) was used for intra-group mean comparisons and independent samples t test (independent samples t test) was used for inter-group mean comparisons.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- In the study, there are two parallel groups as control and intervention groups
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Health Belief Model Based Cardiovascular Disease Risk Factor Prevention Education, Behavioral: Reminder Short MessagesPrior to the intervention, both the control and intervention groups were interviewed face-to-face and completed the Cardiovascular Disease Risk Awareness Rating Scale (CDRAAS), the Cardiovascular Disease Risk Factor Knowledge Level Scale (CARRF-KL) and the EQ-5D Quality of Life Scale. The intervention group then received health belief model-based cardiovascular disease risk factor prevention training. This training, conducted by the researcher, was carried out in 3 sessions, including interactive question-answer sessions. After the training, a total of 39 reminder text messages were sent to the intervention group via WhatsApp 2-3 times a week for 12 weeks. |
| No intervention | No intervention | –No intervention was given to the control group. After the education given to the intervention group and the reminder text messages sent for 12 weeks, the intervention and control groups were asked to fill out the Cardiovascular Disease Risk Awareness Rating Scale (CDRAAS), Cardiovascular Disease Risk Factor Knowledge Level Scale (CARRF-KL) and EQ-5D Quality of Life Scale again in the same week. After the post-tests were taken, the control group also received training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Over 18 years of age,
- No reading and comprehension problems,
- Individuals who agreed to participate in the study,
- Not having any cardiovascular disease,
- To be working in the institution where the research is carried out,
Key exclusion criteria (6 listed)
- Under 18,
- Having cardiovascular disease,
- Refuses to work or wants to leave during the work,
- Individuals with reading and comprehension problems,
- To have received any training on cardiovascular disease prevention,
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 |
|---|---|---|
| Health Belief Model Based Cardiovascular Disease Risk Factor Prevention EducationAlso: Reminder Short MessagesIn line with the literature review, "Health Belief Model-Based Cardiovascular Disease Risk Factor Prevention Training" was created in order to increase the level of knowledge of firefighters regarding cardiovascular disease risk factors, improve their awareness and positively affect their quality of life. This training was given in 3 different sessions by meeting face-to-face with firefighters in the training hall of the fire stations. Each session lasted 40 minutes. Answers were given to the questions asked at the end of the session. The training was organized under the following main headings: Perceived Sensitivity, Perceived Seriousness, Perceived Barriers, Perceived Self-Efficacy, Health Motivation/Activators | Other | Intervention |
| Reminder Short MessagesAfter the Health Belief Model-Based health education, 39 text messages were sent via WhatsApp application 3-4 times a week for 3 months to increase the effectiveness of the education and the motivation of firefighters in CVD prevention. | Behavioural | Intervention |
Primary outcome
Cardiovascular Disease Risk Awareness Assessment Scale (CDRAAS)
Time frame: two weeks
The scale consists of three sub-dimensions: perceived heart attack/stroke risk, perceived benefits and intentions to change, and healthy eating intentions. The scale, which consists of 22 items in total, is a 4-point Likert scale and is scored between 1 (strongly disagree) and 4 (strongly agree). Higher scale and subscale scores indicate increased awareness of cardiovascular diseases.
2 secondary outcomes
The Cardiovascular Disease Risk Factors Knowledge Level (CARRF-KL)
Time frame: two weeks
EuroQol Quality of Life Scale
Time frame: two 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 5 Aug 2024.
- 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.
Zehra Kartoğlu, M.Sc Student principal investigator
zehra.kartoglu@aljazari.k12.tr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Belief Model Based Cardiovascular Disease Risk Factor Prevention Education and Reminder Short Messages in people with Cardiovascular Diseases, run by Marmara 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 7 inclusion and 6 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 5 Aug 2024. 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?
Cardiovascular Disease Risk Awareness Assessment Scale (CDRAAS) (time frame: two weeks). 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 5 Aug 2024.