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.
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.