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IRCT20221016056204N1 IRCT 2023-03-12 Tehran University of Medical Sciences Effect of M-Health on secondary prevention of coronary artery disease patients The effectiveness of applying Mobile-Health Technology to manage modifiable risk factors of coronary artery disease for secondary prevention: a randomized clinical trial 2022-11-22 anticipated 1544 Complete https://irct.ir/trial/66343 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: The mHealth app asks some simple questions from each person and scores their responses. To keep close contact with participants, thereafter it gives encouraging or warning advice in short time intervals compatible with the patient’s answers. This application covers planning for smoking cessation, management of Hypertension (HTN) and Dyslipidemia (DLP). The app provides information by applying simple sentences, and educational audio and video messages about lifestyle modification. It also reminds regular time for visiting the doctor and taking drugs, Randomization description: Block randomization with a 1:1 allocation using variable block sizes of 2, 4, 6, 8, and 10. Allocation of each subject to the study arms will be performed online to prevent selection bias and respect allocation sequence concealment. (By concealing the allocation sequence). Computer-generated random number list will be utilized using permuted block stratified randomization. Randomization will be performed in 7 different levels based on the type and number of risk factors the patients have. Participants will be categorized in the following 7 levels; 1 - Only CS 4 - CS + HTN 7 - CS + HTN + DLP 2 - Only HTN 5 - CS + DLP 3 - Only DLP 6 - DLP + HTN, Blinding description: The practitioners who evaluate the risk factors controlling status are blinded to group assignment. N/A Coronary Artery disease. Intervention 1: Intervention group: Installation and applying mobile-health technology (Green Heart application) on the smartphone plus routine care. The Green Heart application contains sections for controlling blood pressure, dyslipidemia, and smoking cessation. Educational videos and advice are included in all sections. The blood pressure section includes "Why is blood pressure control important?", "Important points in blood pressure measurement", "Which sphygmomanometer is suitable?", "Recommendations for modifying the lifestyle of a person with hypertension", "Guide to entering maximum and minimum numbers of blood pressure based on the monitor screen of the digital device", "Guide to choosing the size of the blood pressure cuff according to the size of the arm circumference", a space for recording blood pressure where it is possible to enter information twice a day, seven days a week and with each record, the average of blood pressure recorded up to that time and its graph are displayed for the user, and a message corresponding to the average blood pressure is given about the need to visit the doctor or a warning in case of an emergency increase in blood pressure. There is also a possibility for refresh/ reinsertion of information. All the information registered by the user is stored on the server. In the dyslipidemia section, there is a video of food diet and exercise recommendations to control dyslipidemia and a space for entering the number of Low-density lipoprotein cholesterol (LDL-C) according to the picture-guide based on the patient's lab test sheet. After entering LDL-C by the user, questions about the type of dyslipidemia medication (statin/ ezetimibe) and its dose will be asked, and if the entered number is higher than the target, a corresponding message will be sent to him/her about increasing the dose of the medication or referring to the doctor to add another category of medication and if it is normal, it is recommended to continue the drug and do a lab test again after 6 months. In the smoking cessation section, the user is asked questions based on the Fagerstrom test, the duration of smoking, the frequency of quitting, the daily cost of smoking, the use of hookah, the state of the desire to smoke, and the reason for the desire to smoke. Recommendations about the side effects of hookah and the amount of recovered cost in case of complete smoking cessation are given. The degree of smoking dependence is measured, and according to that result, educational videos with the content "Why should I quit?", "How to be prepared to quit smoking?", "Things to do on the first day of quitting smoking", "Food diet and exercise recommendations while quitting smoking", "Recommendations to get rid of temptations while quitting smoking", and "Recommendations and important tips while quitting smoking" are displayed. The application is installed on the patient's mobile phone and the method of entering information and accessing different parts of the application is explained to him/her and one of his close, reliable, literate, and familiar with electronic devices companions. The user name is the mobile phone number and the password is the patient's national code, and each user's information is stored confidentially on the server. In addition to watching educational videos, the user enters information about blood pressure, dyslipidemia, and smoking status according to the instructions and guidelines. Intervention 2: Control group: routine care including advice for lifestyle modification orally, in the format of booklets and pamphlets With the content of "Importance of blood pressure control", "Important points in blood pressure measurement", "Choosing the right sphygmomanometer", "Recommendations to modify the lifestyle of a person with hypertension", "Guide to entering maximum and minimum numbers of blood pressure based on the monitor screen of the digital device", "Guide to choosing the size of the blood pressure cuff according to the size of the arm circumference", "Recommendation to measure and record blood pressure twice a day for seven days on a paper blood pressure chart and bring it with themselves on the day of the visit", "Food diet and exercise recommendations to control dyslipidemia" and a separate booklet for smokers with the content "Why should I quit?", "How to be prepared to quit smoking?", "Things to do on the first day of quitting smoking", "Diet and exercise recommendations while quitting smoking", "Recommendations to get rid of temptations while quitting smoking", and "Recommendations and important points while quitting smoking" which are presented to them. 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 There is no further information
public Mojgan Ghavami
No. 5, First alley, Shafigh balkhi alley, Zolfaghari Ave, Shadmehr Ave, Sattarkhan St.
Tehran Iran (Islamic Republic of) 1456856553 +98 21 6651 3375 m_ghavami@razi.tums.ac.ir Tehran University of Medical Sciences scientific Mojgan Ghavami
No. 5, First alley, Shafigh balkhi alley, Zolfaghari Ave, Shadmehr Ave, Sattarkhan St.
Tehran Iran (Islamic Republic of) 1456856553 +98 21 6651 3375 m_ghavami@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) History of CAD defined as history of myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, coronary angiography confirming stenosis>50% in at least one of the major epicardial coronary arteries or their main branches. Having at least one uncontrolled risk factor including: uncontrolled hypertension, uncontrolled dyslipidemia and current cigarette smoking for ≥12 months. Aged between 25 to 75 years Inclination to staying in study for two years Having and ability of using smart phone by the participant or one of his/her trustworthy relatives who lives near him/her Willing to control the risk factors using App Provides informed consent to participate in the study 25 years 75 years Both Mental retardation Individuals with prohibitive morbidity that requires close face-to-face monitoring. End stage chronic disease such as: hepatic and/or renal failure, heart failure, active cancer 125.1 125.0 Prevention Prevention Intervention group: Installation and applying mobile-health technology (Green Heart application) on the smartphone plus routine care. The Green Heart application contains sections for controlling blood pressure, dyslipidemia, and smoking cessation. Educational videos and advice are included in all sections. The blood pressure section includes "Why is blood pressure control important?", "Important points in blood pressure measurement", "Which sphygmomanometer is suitable?", "Recommendations for modifying the lifestyle of a person with hypertension", "Guide to entering maximum and minimum numbers of blood pressure based on the monitor screen of the digital device", "Guide to choosing the size of the blood pressure cuff according to the size of the arm circumference", a space for recording blood pressure where it is possible to enter information twice a day, seven days a week and with each record, the average of blood pressure recorded up to that time and its graph are displayed for the user, and a message corresponding to the average blood pressure is given about the need to visit the doctor or a warning in case of an emergency increase in blood pressure. There is also a possibility for refresh/ reinsertion of information. All the information registered by the user is stored on the server. In the dyslipidemia section, there is a video of food diet and exercise recommendations to control dyslipidemia and a space for entering the number of Low-density lipoprotein cholesterol (LDL-C) according to the picture-guide based on the patient's lab test sheet. After entering LDL-C by the user, questions about the type of dyslipidemia medication (statin/ ezetimibe) and its dose will be asked, and if the entered number is higher than the target, a corresponding message will be sent to him/her about increasing the dose of the medication or referring to the doctor to add another category of medication and if it is normal, it is recommended to continue the drug and do a lab test again after 6 months. In the smoking cessation section, the user is asked questions based on the Fagerstrom test, the duration of smoking, the frequency of quitting, the daily cost of smoking, the use of hookah, the state of the desire to smoke, and the reason for the desire to smoke. Recommendations about the side effects of hookah and the amount of recovered cost in case of complete smoking cessation are given. The degree of smoking dependence is measured, and according to that result, educational videos with the content "Why should I quit?", "How to be prepared to quit smoking?", "Things to do on the first day of quitting smoking", "Food diet and exercise recommendations while quitting smoking", "Recommendations to get rid of temptations while quitting smoking", and "Recommendations and important tips while quitting smoking" are displayed. The application is installed on the patient's mobile phone and the method of entering information and accessing different parts of the application is explained to him/her and one of his close, reliable, literate, and familiar with electronic devices companions. The user name is the mobile phone number and the password is the patient's national code, and each user's information is stored confidentially on the server. In addition to watching educational videos, the user enters information about blood pressure, dyslipidemia, and smoking status according to the instructions and guidelines. Control group: routine care including advice for lifestyle modification orally, in the format of booklets and pamphlets With the content of "Importance of blood pressure control", "Important points in blood pressure measurement", "Choosing the right sphygmomanometer", "Recommendations to modify the lifestyle of a person with hypertension", "Guide to entering maximum and minimum numbers of blood pressure based on the monitor screen of the digital device", "Guide to choosing the size of the blood pressure cuff according to the size of the arm circumference", "Recommendation to measure and record blood pressure twice a day for seven days on a paper blood pressure chart and bring it with themselves on the day of the visit", "Food diet and exercise recommendations to control dyslipidemia" and a separate booklet for smokers with the content "Why should I quit?", "How to be prepared to quit smoking?", "Things to do on the first day of quitting smoking", "Diet and exercise recommendations while quitting smoking", "Recommendations to get rid of temptations while quitting smoking", and "Recommendations and important points while quitting smoking" which are presented to them. Smoking Cessation. Timepoint: Three months post-randomization. Method of measurement: Self-report for quitting smoking. Blood pressure control to less than 130/80 mm Hg. Timepoint: Three months post-randomization. Method of measurement: Sphygmomanometer/Blood pressure measurement by the physician in the clinic. Dyslipidemia control with the target of low-density lipoprotein cholesterol (LDL-C) less than 55 mg/dL. Timepoint: Three months post-randomization. Method of measurement: Lab test to measure low-density lipoprotein cholesterol. Tehran University of Medical Sciences Approved 2020-04-30 Ethics committee of Tehran University of Medical Scinces Research institute building, Tehran Heart Center, North Kargar St Tehran Tehran Iran (Islamic Republic of)