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IRCT2015111712211N2 IRCT 2016-01-01 Tehran University of Medical Sciences Evaluation of the effectiveness of a mobile app for self-management of hypertension Blood Pressure Management application(BPMap) Designing a mobile app for the control of essential hypertension, based on the PRECEDE-PROCEED model, and evaluation of its effectiveness on patients’ self-management compared to the usual care 2016-02-04 anticipated 132 Complete https://irct.ir/trial/12324 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive. N/A primary hypertension. Interventions: Intervention group: Intervention group one, in addition to the usual care, the educational – supportive intervention (usual care plus intervention) will be carried out by installing the software on the Smartphone. This application has been developed with the goal of allowing self-management for the optimum detection and control of the determinant factors of hypertension and overcoming the barriers to adherence (BPMap=blood pressure management application). The items available in the application are: reminder for drug use, the doctor’s appointment, physical activity, blood pressure measurement • Reminder for drug use, doctor’s appointment, physical activity, blood pressure measurement • Knowledge information on the disease, its etiology, causes of disease, influential factors of disease control • Knowledge information, encouragement and reminders for quitting and reduction of smoking • Guidance and provision of a healthy nutritional diet (DASH and low-salt diet) and a weight reduction diet based on BMI and other personal characteristics • The recording of blood pressure in the application and provision of advice appropriate to the recorded rate • Delivery of data to the physician and researcher A session will be held during which the intervention group’s participants will be briefed on the goals of the study and the research team’s expectations. The application will be installed on their mobile phones and they will be taught how to operate it. Based on their drugs and individual characteristics, the patients will then set their applications accordingly. They will operate the application in the presence of the research team, so that, if any problem arises it may be resolved by the research team. The patients will then be examined at the clinic once every two weeks. Control group: The second group will receive the usual care. The usual care consists of blood pressure measurement, responding to the patient’s questions, prescription of earlier drugs or changing the drug used and explaining its method of use, in accordance with the patient’s circumstances and the specialist’s opinion..
public Mahnaz Ashoorkhani
Faculty of Health-Tehran University of Medical Sciences, Poorsina St, Qods St, Keshavarz Blvd, Tehran, Iran.
Tehran Iran (Islamic Republic of) +98 21 4293 3333 ashoorkhani1392@yahoo.com Faculty of Health-Tehran University of Medical Sciences scientific Mahnaz Ashoorkhani
Faculty of Health-Tehran University of Medical Sciences, Poorsina St, Qods St, Keshavarz Blvd, Tehran, Iran.
Tehran Iran (Islamic Republic of) +98 21 4293 3333 ashoorkhani1392@yahoo.com- ashoorkhani@farabi.tums.ac.ir Faculty of Health-Tehran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria:The diagnosis of essential hypertension, without its complications, such as cardiovascular accidents etc ; Being medically treated for hypertension ; Age of patients between 30 and 60 years ; Having a Smartphone and/or tablet ; The ability to read Persian ; Inclination to participate in the study ; Intention to reside in the site of study for the next 6 months Exclusion criteria: Presence of other cardiovascular diseases ; Diabetes mellitus ; Physical disability 30 years 60 years Both I10 Essential (primary) hypertension Prevention Interventions: Intervention group: Intervention group one, in addition to the usual care, the educational – supportive intervention (usual care plus intervention) will be carried out by installing the software on the Smartphone. This application has been developed with the goal of allowing self-management for the optimum detection and control of the determinant factors of hypertension and overcoming the barriers to adherence (BPMap=blood pressure management application). The items available in the application are: reminder for drug use, the doctor’s appointment, physical activity, blood pressure measurement • Reminder for drug use, doctor’s appointment, physical activity, blood pressure measurement • Knowledge information on the disease, its etiology, causes of disease, influential factors of disease control • Knowledge information, encouragement and reminders for quitting and reduction of smoking • Guidance and provision of a healthy nutritional diet (DASH and low-salt diet) and a weight reduction diet based on BMI and other personal characteristics • The recording of blood pressure in the application and provision of advice appropriate to the recorded rate • Delivery of data to the physician and researcher A session will be held during which the intervention group’s participants will be briefed on the goals of the study and the research team’s expectations. The application will be installed on their mobile phones and they will be taught how to operate it. Based on their drugs and individual characteristics, the patients will then set their applications accordingly. They will operate the application in the presence of the research team, so that, if any problem arises it may be resolved by the research team. The patients will then be examined at the clinic once every two weeks. Control group: The second group will receive the usual care. The usual care consists of blood pressure measurement, responding to the patient’s questions, prescription of earlier drugs or changing the drug used and explaining its method of use, in accordance with the patient’s circumstances and the specialist’s opinion. Adherence to hypertensive drug use. Timepoint: Before the intervention – two months after the intervention – 6 months after the intervention. Method of measurement: Hill bone questionnaire. Adherence to the DASH diet and sodium reduction. Timepoint: Before the intervention – two months after the intervention – 6 months after the intervention. Method of measurement: questionnaire. Hypertension. Timepoint: Before the intervention and upon every visit – the blood pressures recorded in the application. Method of measurement: Mercury sphygmomanometer. Regular monitoring of blood pressure. Timepoint: three times in week. Method of measurement: register in application. Predisposing –enabling & reinforcing factors of adherence to treatment of primary hypertensive patients. Timepoint: Before the intervention – two months after the intervention – 6 months after the intervention. Method of measurement: questionnaire. Tehran University of Medical Sciences Approved 2015-10-04 Ethics Committee of Tehran University of Medical Sciences Tehran University of Medical Sciences, Central Building, Qods St., Keshavarz Blvd., Tehran, Iran. tehran Iran (Islamic Republic of)