]>
IRCT20220502054719N1 IRCT 2022-05-27 Shahid Beheshti University of Medical Sciences Investigating the effect of RAM on adherence to treatment and medication regimen of hypertensive people Investigating the effect of education based on Roy's adaptation model on adherence to the treatment and medication regimen of patients with hypertension in comprehensive health centers affiliated of Shahid Beheshti University of Medical Sciences in Tehran in 2022 2022-05-15 anticipated 134 Complete https://irct.ir/trial/63372 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: Cluster randomized method will be used in this clinical trial. At first a list of health care centers affiliated to Shahid Beheshti University of Medical Sciences will be attained(North, Shemiranat and East). Then a zone will be chosen randomly and 2 health care centers will be chosen by draw randomly as clusters. Name of health centers will be put into same balls and they will be put into a pot, after mixing the balls one ball will be chosen randomly and first ball chosen will be the health center considered as the luster which interventions group will be chosen from there. The second ball chosen will be the health center considered as the cluster which control group will be chosen there. Then participants will be chosen from each cluster by random table number. It mean intervention group and control group are chosen before using random number table. So random number table will not determine which patient will be in intervention group or control group because intervention group and control group has been chosen by draw before. One health center is the intervention group and the other one is the control group by draw as explained. Therefore it is clear that each health center is chosen as a cluster and it is clear that which cluster contains intervention group and the other cluster contains control group. Then among all patients available for intervention or control group 67 patients will be chosen for each group by random number table. In the end in each of intervention and control groups a number will be given to all patients available then the numbers will be organized in columns or rows and researcher will choose randomly the starting point by eyes closed and a pen and first numbers chosen by eyes closed will be considered as chosen samples. By choosing each number the next number will be chosen among bigger numbers. Then choosing numbers randomly will be continued by eyes closed until 67 patients be chosen for each group. N/A Hypertension. Intervention 1: Intervention group: People with hypertension are randomly divided into 4 groups, each group includes 8 or 9 patients. Each session lasts 45-60 minutes. In each session patients will be educated about one mode of Roy's adaptation model. Based on data collected from Pre-test session patients will be educated about each mode pf Roy's model in separate sessions. In session 2 patients will be educated about physiologic mode like: education about the effect of medications in controlling hypertensive situations. Education about when can they stop taking their medications and about exercising and its effects and also what can happen if they spontaneously stop taking their medications. In session 3 Patients will be educated about self-concept mode: The effect of managing stress and anxiety in preventing of hypertensive situations, talking about stressful factors to intimate people and friends to lessen anxiety, talking about stress managing skills. In session 4 patients will be educated about role function mode: Educating about the importance of being among family and in society and taking advise from successful people in controlling hypertension. Educating about controlling blood pressure twice a week and taking to their physician each 3 week about status of hypertension and medications they take. In session 5 patients will be educated about interdependence mode: Educating about talking about stressful factors to family members to reduce stressful moments, importance of gaining support from family and the effect of family members and friends in improving adherence to treatment plan and medication regimen. And educating about how religious beliefs parallel to care plan can improve the adherence to treatment and medications. At the end of sessions a needs assessment form will be given to participants to see if they need more education or not. Intervention 2: Control group: People with hypertension. In this group, clients will be educated about hypertension same as the routine of that health center. 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 Publication plan will be decided later.
public Amirmohamad Amidi
Iran, Tehran Velenjak St. , Shahid Chamran Highway
Tehran Iran (Islamic Republic of) نامشخص +98 21 8865 5382 amirmohamad.amidi@gmail.com Shahid Beheshti University of Medical Sciences scientific Dr. Meimanat Hosseini
Iran, Tehran Velenjak St. , Shahid Chamran Highway
Tehran Iran (Islamic Republic of) نامشخص +98 21 8865 5382 meimanathosseini@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Diagnosed as a hypertensive patient by a physician Taking anti-hypertension medications Being able to read and write Covered by a comprehensive health center Minimum age 18 years old and maximum age 60 years old 18 years 60 years Both Unwillingness to participate in the study I15.9 Secondary hypertension, unspecified Lifestyle Lifestyle Intervention group: People with hypertension are randomly divided into 4 groups, each group includes 8 or 9 patients. Each session lasts 45-60 minutes. In each session patients will be educated about one mode of Roy's adaptation model. Based on data collected from Pre-test session patients will be educated about each mode pf Roy's model in separate sessions. In session 2 patients will be educated about physiologic mode like: education about the effect of medications in controlling hypertensive situations. Education about when can they stop taking their medications and about exercising and its effects and also what can happen if they spontaneously stop taking their medications. In session 3 Patients will be educated about self-concept mode: The effect of managing stress and anxiety in preventing of hypertensive situations, talking about stressful factors to intimate people and friends to lessen anxiety, talking about stress managing skills. In session 4 patients will be educated about role function mode: Educating about the importance of being among family and in society and taking advise from successful people in controlling hypertension. Educating about controlling blood pressure twice a week and taking to their physician each 3 week about status of hypertension and medications they take. In session 5 patients will be educated about interdependence mode: Educating about talking about stressful factors to family members to reduce stressful moments, importance of gaining support from family and the effect of family members and friends in improving adherence to treatment plan and medication regimen. And educating about how religious beliefs parallel to care plan can improve the adherence to treatment and medications. At the end of sessions a needs assessment form will be given to participants to see if they need more education or not. Control group: People with hypertension. In this group, clients will be educated about hypertension same as the routine of that health center. Adherence to treatment plan. Timepoint: Before intervention and after intervention. Method of measurement: Hill-Bone High Blood Pressure Compliance Scale. Adherence to medication regimen. Timepoint: Before intervention and after intervention. Method of measurement: Morisky Medication Adherence Scale (mmas-8). Blood Pressure. Timepoint: Before intervention and after intervention. Method of measurement: Sphygmomanometer available in the health care center. Thesis Budget Approved 2022-04-26 Iran national committee for ethics in biomedical research Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)