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IRCT20200321046826N1 IRCT 2021-11-05 Primary Prevention of Cardiovascular Diseases Research Center, Tehran University of Medical Sciences Evaluation of the effectiveness of education with a mobile application on the prevention of atherosclerotic coronary artery diseases risk factors Design, implementation, and evaluation of mobile application based on integrated behavior change model for primary prevention of atherosclerotic coronary artery disease risk factors. 2021-09-23 anticipated 430 Complete https://irct.ir/trial/57833 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Permuted block randomization method will be used in this study to randomize the samples. Blocking is used to balance the number of samples assigned to each of the study groups. This feature helps researchers in cases where the need for intermediate analysis during the sampling process in this method, the number of people assigned to each group is almost equal. In this method, blocks are formed based on the considered variables and within each block, half of the people are involved and half are considered as controls. The main goal of this method is to balance the number of participants in each group. The size of all blocks is equal and we will have 108 blocks of 4 in this two-group experiment (including 2 participants in the intervention group and 2 participants in the control group). Random allocation sequence and list of blocks will be obtained by the statistical consultant with the help of software. The website https://www.sealedenvelope.com is a useful site for generating random sequences for block randomization. This site is designed in such a way that there is no limit to the number of groups for random allocation. The 4-volume block method is used to create a random allocation sequence. According to the total number of samples required for the study, which is 430 patients (215 patients in the intervention group (A) and 215 patients in the control group (B), 108 quadruple blocks including two groups A and B were randomly selected through design software. It can be like ..... (ABAB), (BBAB), (AABB), (ABBA), (BAAB). Based on the sample size, 430 envelopes (215 envelopes containing paper containing A) and (215 envelopes containing paper Contains B) Based on the list of randomly prepared quadruple blocks, a trained person outside the research team is responsible for randomly assigning participants, after each participant enters, according to the 108 quadruple blocks prepared in the first stage. Each patient will be randomly assigned to group A (intervention) or B (control group) and the sampling process will be performed consecutively until the end of sampling. For example, according to the block (ABAB), after obtaining the informed consent of each person after entering the study, he/she enters the intervention, control, intervention, and control groups, respectively. The rain block will continue. Then, to hide the random allocation, non-transparent envelopes with random sequences (Sequentially numbered, sealed opaque envelopes) will be used. It will be written and placed in envelopes in order. The production of the allocation sequence and the preparation of the envelopes based on it will be done by a person not involved in the research. It is noteworthy that in the process of performing random allocation, the specialist has created a random sequence statistic, the cardiologist will examine the participants in terms of inclusion and exclusion criteria and will include them in the study and the researcher allocate participants' intervention and control group. Then, in order to hide the random allocation, non-transparent envelopes with random sequence (Sequentially numbered, sealed opaque envelopes) will be used. It will be written and placed in envelopes in order. The production of the allocation sequence and the preparation of the envelopes based on it will be done by a person not involved in the research. It is noteworthy that in the process of performing random allocation, the specialist has created a random sequence statistic, the cardiologist will examine the participants in terms of inclusion and exclusion criteria and will include them in the study and the researcher will send the participants to the group. Will allocate intervention and control measures, Blinding description: This study is a single-blind controlled trial that includes the control group (not receiving the intervention) and the first intervention group (receiving training with mobile software). In this way, the outcome can be measured objectively. Due to the nature of the study and the fact that the researcher performs the educational intervention and also the participants are aware of the type of training they receive (routine clinic training or mobile training program) it is not possible to blind the participants and the researcher. In this intervention, to prevent possible bias in the results of the study, all samples will be screened by a cardiologist who is not aware of how the samples are placed in the intervention and control groups. The score-2 will be determined at the beginning of the study and individuals with a risk score of 2.5 to 15% will be included in the study. Also, in this study, the data analyzer is blinded and will not be aware of how individuals are assigned to groups and the method used for training. Then, to hide the random allocation, non-transparent envelopes with random sequences (Sequentially numbered, sealed opaque envelopes) will be used. It will be written and placed in envelopes in order. The production of the allocation sequence and the preparation of the envelopes based on it will be done by a person not involved in the research. It is noteworthy that in the process of performing random allocation, the specialist has created a random sequence statistic, the cardiologist will examine the participants in terms of inclusion and exclusion criteria and will include them in the study and the researcher allocate participants' intervention and control group. 3 Atherosclerotic coronary artery disease. Intervention 1: Intervention group: The intervention includes three phases: pre-test, content education, and post-test. Pre-tests in both intervention and control groups are sent to their mobile phones as an online questionnaire. During a meeting, the members of the intervention group are introduced to the objectives of the study, and the expectations of the study team are raised from them. The application is installed on their mobile phones and how to work with it will be explained in the first face-to-face visit to Tehran Heart Center Hospital. The educational content in the intervention group will be activated immediately after completing the pre-test form. For 6 months at any time and place have access to educational content based on the needs assessment and recommendations of classes AI, IIA, IB guidelines of primary prevention of heart disease. From the first month, weekly behavioral reminder messages will be sent. One month later, 3 months later, and 5 months later, telephone counseling and follow-up will be provided. At the end of 6 months, access to educational content will be automatically disabled. And the link to receive the post-test by the researcher is sent immediately, 6 months after the educational intervention to both intervention and control groups. Intervention 2: Control group: will receive the usual treatment. Common office treatments include clinical and laboratory evaluation, answering the patient's questions, prescribing the previous drug or changing the medication, and explaining how to use it according to the patient's condition and the specialist physician and education in the office. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is After the intervention
public Afsaneh Aein
Shahid Hemmat Highway Between Sheikh Fazl Allah Nouri and Shahid Chamran Iran University of Medical Sciences
Tehran Iran (Islamic Republic of) 1449614535 +2166947769 AFSANEH.AEIN@GMAIL.COM Iran University of Medical Sciences scientific Dr Mahnaz Solhi
Shahid Hemmat Highway between Sheikh Faz Allah Nouri and Shahid Chamran Iran University of Medical Sciences
Tehran Iran (Islamic Republic of) 1449614535 +2186704758 solhi.m@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Have two or more risk factors for coronary artery atherosclerosis include an unhealthy diet, physical inactivity, high blood pressure, high blood fats, high blood sugar, obesity, smoking. Obtain a risk score of 2.5-15% based on cardiovascular disease risk assessment. 75 - 18 years old Have a desire to participate in the study Have a smartphone or tablet Have the ability to work with mobile applications Intention to stay at the place of study for the next one year 18 years 75 years Both History of cardiovascular diseases Physical disability Existence of other chronic diseases Mental Disease I25.0 Atherosclerotic cardiovascular disease Prevention Prevention Intervention group: The intervention includes three phases: pre-test, content education, and post-test. Pre-tests in both intervention and control groups are sent to their mobile phones as an online questionnaire. During a meeting, the members of the intervention group are introduced to the objectives of the study, and the expectations of the study team are raised from them. The application is installed on their mobile phones and how to work with it will be explained in the first face-to-face visit to Tehran Heart Center Hospital. The educational content in the intervention group will be activated immediately after completing the pre-test form. For 6 months at any time and place have access to educational content based on the needs assessment and recommendations of classes AI, IIA, IB guidelines of primary prevention of heart disease. From the first month, weekly behavioral reminder messages will be sent. One month later, 3 months later, and 5 months later, telephone counseling and follow-up will be provided. At the end of 6 months, access to educational content will be automatically disabled. And the link to receive the post-test by the researcher is sent immediately, 6 months after the educational intervention to both intervention and control groups. Control group: will receive the usual treatment. Common office treatments include clinical and laboratory evaluation, answering the patient's questions, prescribing the previous drug or changing the medication, and explaining how to use it according to the patient's condition and the specialist physician and education in the office. Knowledge score about risk factors for coronary artery atherosclerotic disease. Timepoint: Before the intervention and six months after the intervention. Method of measurement: Researcher-made questionnaire on knowledge of risk factors for atherosclerotic coronary heart disease. Risk perception score on risk factors for atherosclerotic coronary heart disease. Timepoint: Before the intervention and six months after the intervention. Method of measurement: Researcher-made risk perception questionnaire about risk factors for atherosclerotic coronary heart disease. Attitude score on risk factors for atherosclerotic coronary artery disease. Timepoint: Before the intervention and six months after the intervention. Method of measurement: Researcher-made attitude questionnaire about risk factors for atherosclerotic coronary heart disease. Perceived self-efficacy score on risk factors for atherosclerotic coronary heart disease. Timepoint: Before the intervention and six months after the intervention. Method of measurement: Researcher-made perceived self-efficacy questionnaire on risk factors for coronary atherosclerotic disease. Perceived social support score on risk factors for coronary artery atherosclerotic disease. Timepoint: Before the intervention and six months after the intervention. Method of measurement: Researcher-made social support questionnaire on the risk factors for coronary atherosclerotic disease. Score of preventive behavior on risk factors for atherosclerotic coronary artery disease. Timepoint: Before the intervention and six months after the intervention. Method of measurement: Researcher-made preventive behavior questionnaire on risk factors for atherosclerotic coronary heart disease. Satisfaction with the use of mobile application. Timepoint: Six months after the intervention. Method of measurement: User Experience Questionnaire(UEQ) - Persian Version. Blood pressure. Timepoint: Before the intervention and six months after the intervention. Method of measurement: Mercury sphygmomanometers. Triglyceride. Timepoint: Before the intervention and six months after the intervention. Method of measurement: Spectrophotometry. Low density lipoprotein (LDL). Timepoint: Before the intervention and six months after the intervention. Method of measurement: Spectrophotometry. High Density Lipoprotein (HDL). Timepoint: Before the intervention and six months after the intervention. Method of measurement: Spectrophotometry. Cholesterol. Timepoint: Before the intervention and six months after the intervention. Method of measurement: Spectrophotometry. Fasting blood sugar. Timepoint: Before the intervention and six months after the intervention. Method of measurement: Spectrophotometry. Body Mass Index (BMI). Timepoint: Before the intervention and six months after the intervention. Method of measurement: Calibrated weights, meters to measure height. Weight. Timepoint: Before the intervention and six months after the intervention. Method of measurement: Digital scales. Healthy eating habits. Timepoint: Before the intervention and six months after the intervention. Method of measurement: National Survey Questionnaire on non-communicable diseases risk factors-WHO STEPS Instrument. Physical activity. Timepoint: Before the intervention and six months after the intervention. Method of measurement: International Physical Activity Questionnaire - Short Form (IPAQ). Smoking. Timepoint: Before the intervention and six months after the intervention. Method of measurement: National Survey Questionnaire on non-communicable diseases risk factors-WHO STEPS Instrument. Mental health. Timepoint: Before the intervention and six months after the intervention. Method of measurement: European Society of Cardiology (ESC) psychosocial screening instrument. Primary Prevention of Cardiovascular Diseases Research Center, Tehran University of Medical Sciences Approved 2018-10-28 National Ethics System in Biological Research Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran. Website Statistics Tehran Tehran Iran (Islamic Republic of)