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IRCT20231202060239N1 IRCT 2024-01-14 Tehran University of Medical Sciences The effect of interactive intervention taking place in social messenger platforms on medication adherence and blood pressure control The effect of interactive intervention in the platform of social messengers according to protection motivation theory on medication adherence and blood pressure control in adults with hypertension 2024-03-20 anticipated 142 Complete https://irct.ir/trial/74086 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Eligible participants will be allocated into two groups: intervention and control, using a block randomization method with a block size of 4. The supervisor will handle the generation of the random sequence and allocation concealment, while the student will conduct the sampling. To maintain concealment, dark envelopes, equal to the sample size, will be used. These envelopes will contain papers with random sequences. Upon joining the study, each participant will receive an envelope from the researcher. The paper inside the envelope will determine the participant’s group assignment, Blinding description: In the present study, only the statistical analyst will not be informed about the allocation of the participants to the intervention and control groups. In this way, the data related to the participants will be delivered to the statistical analyst in coded form (for example, the intervention group with the letter A and the control group with the letter B). After the completion of the data analysis and evaluation of the relevant consequences after the completion of the implementation of the intervention, each code will be finally determined so that after comparing the data, the final result of the effectiveness of the intervention or its absence will be realized. N/A Primary hypertension. Intervention 1: Intervention group: After establishing communication between the researcher and the people of the intervention group in messengers selected from the previously announced priorities (Soroush, Eitaa, Telegram, WhatsApp), an intervention within 3 months for the people of the intervention group by sending a daily message reminding them to take medicine and a message with multimedia content prepared based on the constructs of the protection motivation theory will be sent on the social messenger platform of their choice. A reminder message to take the medicine according to the list prepared according to the demographic questionnaire (name of the medicine, usual time of taking the medicine) and five minutes before the time of taking the medicine in the corresponding messaging platform with a message containing the name of the medicine, the dose of the medicine, the exact time of taking the medicine and the word "time of taking the medicine" "Your medicine has arrived. Do not delay taking your medicine." Along with the drug usage tips, including: 1) blood pressure control and after taking blood pressure medication, and 2) tips related to the drug used, are sent to the person and they are asked to send a message for feedback and confirmation in case of taking the drug. They should also declare the use of medication and medication errors in order to register.The people of the intervention group can send their questions to the researcher to be answered in the relevant messengers. A message prepared according to the constructs of the protection motivation theory is also sent one number per day and at a random hour between 10 am and 8 pm. All feedbacks from peoples in the intervention group will be recorded and their questions about the submitted content will be answered. All the questions asked will be recorded and part of the content of the message sent every three days will be non-repeating questions asked by patients and their answers. At the end of each week of the implementation of the intervention, people are requested to send a message to inform the researcher of any change in the type or dosage of the drug used. Intervention 2: Control group: The people of the control group will also receive the usual care during three months and no intervention will be done. Just to attend for blood pressure measurement, they will receive the same message as the people in the intervention group at the same time and under the same conditions. After 97 days (7 days after the completion of sending the intervention), the people of both groups will come to the center for the final blood pressure measurement and recording, and after the blood pressure control, the medication compliance questionnaire will be provided to both the intervention and control groups for completion. At the end of the implementation of the program, the content designed based on the protection motivation theory will be provided to the control group. 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 .
public Reza Negarandeh
Nursing and Midwifery Care Research Center, School of Nursing Midwifery, Tehran University of Medical Sciences , Dr. Mirkhani St. (East Nusrat), Tohid sq.
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6642 1685 negarandeh@gmail.com Tehran University of Medical Sciences scientific Reza Negarandeh
Nursing and Midwifery Care Research Center, School of Nursing Midwifery, Tehran University of Medical Sciences , Dr. Mirkhani St. (East Nusrat), Tohid sq.
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6642 1685 negarandeh@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Diagnosis of primary hypertension by a physician Minimum use of one anti-hypertensive medication prescribed by a physician Age between 18 to 65 years Ability to read and write (being literate) Possession of a smartphone and ability to use it and access the internet The ability to use the facilities of social messaging platforms (the person should have the minimum ability to send and receive messages in any possible form (text, voice, etc.) Have an account in at least one social messaging platform such as Whats App, Telegram, Eitaa, Soroush) 18 years 65 years Both Participation in previous similar studies Concurrent involvement in other research or interventions Use of special or expensive medications Use of injectable anti hypertensive drugs Having sensory impairments including vision, hearing, and touch Addiction to drugs,narcotics presence of comorbidities (such as diabetes, asthma, cancer, and renal disorders) I10 Essential (primary) hypertension Behavior Behavior Intervention group: After establishing communication between the researcher and the people of the intervention group in messengers selected from the previously announced priorities (Soroush, Eitaa, Telegram, WhatsApp), an intervention within 3 months for the people of the intervention group by sending a daily message reminding them to take medicine and a message with multimedia content prepared based on the constructs of the protection motivation theory will be sent on the social messenger platform of their choice. A reminder message to take the medicine according to the list prepared according to the demographic questionnaire (name of the medicine, usual time of taking the medicine) and five minutes before the time of taking the medicine in the corresponding messaging platform with a message containing the name of the medicine, the dose of the medicine, the exact time of taking the medicine and the word "time of taking the medicine" "Your medicine has arrived. Do not delay taking your medicine." Along with the drug usage tips, including: 1) blood pressure control and after taking blood pressure medication, and 2) tips related to the drug used, are sent to the person and they are asked to send a message for feedback and confirmation in case of taking the drug. They should also declare the use of medication and medication errors in order to register.The people of the intervention group can send their questions to the researcher to be answered in the relevant messengers. A message prepared according to the constructs of the protection motivation theory is also sent one number per day and at a random hour between 10 am and 8 pm. All feedbacks from peoples in the intervention group will be recorded and their questions about the submitted content will be answered. All the questions asked will be recorded and part of the content of the message sent every three days will be non-repeating questions asked by patients and their answers. At the end of each week of the implementation of the intervention, people are requested to send a message to inform the researcher of any change in the type or dosage of the drug used. Control group: The people of the control group will also receive the usual care during three months and no intervention will be done. Just to attend for blood pressure measurement, they will receive the same message as the people in the intervention group at the same time and under the same conditions. After 97 days (7 days after the completion of sending the intervention), the people of both groups will come to the center for the final blood pressure measurement and recording, and after the blood pressure control, the medication compliance questionnaire will be provided to both the intervention and control groups for completion. At the end of the implementation of the program, the content designed based on the protection motivation theory will be provided to the control group. Medication Adherence. Timepoint: Before intervention and 97 days after the intervention. Method of measurement: Hill-Bone Medication Adherence Scale (HB-MAS9) ,Kim et al. 2000. Controlled blood pressure: In this study, blood pressure less than 140 mm Hg (systolic) and 90 mm Hg (diastolic) will be considered as controlled blood pressure. Timepoint: Before implementing the intervention at the beginning of the study (baseline) and then 97 days after the onset of interactive intervention. Method of measurement: In this study, blood pressure measurements will be taken from the participants after they’ve rested for five minutes in a seated position. A calibrated sphygmomanometer will be used on the patient’s right arm for these measurements. This process will be repeated twice, with a 10-minute interval between the measurements. Tehran University of Medical Sciences Approved 2023-11-29 Research Ethics Committee, School of Medicine, Tehran University of Medical Sciences Ethics Committee, Faculty of Medicine, Poursina St. , Ghods St., Enghelab St. Tehran Tehran Iran (Islamic Republic of)