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IRCT20170123032129N6 IRCT 2018-10-20 Hamedan University of Medical Sciences Effectiveness of an educational intervention (the Encourage Autonomous Self-Enrichment Program) on self- management in Patients with high blood pressure EASE Effectiveness of an educational intervention (the Encourage Autonomous Self-Enrichment Program) on self- management in Patients with high blood pressure referred to ّّFarshchian cardiac outpatient in Hamadan 2018. 2018-10-23 anticipated 70 Complete https://irct.ir/trial/34116 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: After referring to the outpatient heart clinic for patients with hypertension and introducing them to the authorities, the samples will be selected first. having criteria for entering the study will be reviewed. then 35 cards with A letters and 35 cards with B letter will be placed inside sealed envelopes and each patient will select one of these cards randomly without placement, and if you select the letter A, will be In the test group and if the card is selected B, they will be in the control group. N/A Primary blood pressure. Intervention 1: Intervention group: After registration of patients who want to participate in research projects. The goals and the process of research will be explained to them. Patient's informed consent will be filled out. If they have inclusion criteria, they participate in the study. demographic information will be taken. This study was designed as a simple randomized controlled etrial with one-to-one allocation into two groups. The intervention group participated in the EASE program will be 35 and control group too.The EASE program in six steps is as follows for the intervention group: During step 1 of this program, information about the participant’s demographic characteristics, treatment plan, and examination data was gathered. The appropriateness of each patient’s medical care was confirmed, and participants were evaluated to ensure their psychological and physical preparedness. Client–professional relationship a major influence on healthcare behaviors (Interaction model) (First session). In Step 2, nurses encouraged participants to independently clarify issues related to their lifestyle and determine the self-management techniques needed for a healthier lifestyle (Express the positive and negative issues of lifestyle in relation to blood pressure), and Self-management approaches to improve healthy lifestyles (The factors and behaviors that reduce the blood pressure and its complications will be named and appropriate answers will be encouraged) ( Promotion model, Self efficacy) (second session). In Step 3, participants were involved in the setting of specific goals to foster self-efficacy and received support for their autonomous achievement of these goals, as enhanced self-efficacy is thought to lead to behavioral changes (Self efficacy, Promotion model) (second session). In step 4, techniques for achieving these goals were selected. In this study, self-monitoring was used to monitor the participants' actions and emotions toward their goals. The participants used self-monitoring techniques that involved monitoring of their actions and related benefits, which were logged using monitoring notes. Other techniques were added according to the participant’s condition; these included behavioral reinforcement and incremental goal achievement (action goals were set using small steps that initiated from achievable goals). Encouraging achievements, planning minor goals for achieving success and gaining positive experiences, encouraging verbal and nonverbal ways to increase repetition of behavior, creating optimism and hope for breakthroughs that will all enhance patient self-efficacy ( Promotion model, Self efficacy) (The third and fourth sessions). For Step 5, the nurses supported the participants' achievements of their action goals through interviews (fifth meeting) and phone or e-mail communication that patients will be contacted for 3-5 weeks every three days every 10 to 10 minutes, and guidance and encouragement will be used to strengthen positive behaviors and will support the achievements of the participants in achieving the desired goals (Promotion model, Self efficacy). For step 6: Achieving the desired goals will be evaluated. After eight weeks from the completion of the study, the variables will be re-evaluated as self-report at the clinic's meeting for re-examination (sixth session). Intervention 2: 35 patients will be in control group. The control group won't participate in education sessions. The control group will receive routine education based on health centers program according to national protocols. At the first, control group will receive self-management, and self-monitoring of blood pressure questionnaires. Blood tests, Body Mass Index, blood pressure, will be measured too. After 3 months, the questionnaires, Clinical blood tests and BMI, blood pressure will be done again. 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 "No more information"
public عظیم عزیزی
Hamadan University of Medical Science, Shahid Fahmide boulevard
Hamadan Iran (Islamic Republic of) 00988138380150 +98 81 3838 0150 a.azizi@umsh.ac.ir Hamedan University of Medical Sciences scientific Azim Azizi
آدرس خیابان Hamadan University of Medical Science, Shahid Fahmide boulevard
Hamadan Iran (Islamic Republic of) 00988138380150 +98 81 3838 0150 a.azizi@umsh.ac.ir Hamedan University of Medical Sciences Iran (Islamic Republic of) Patients have the ability to read and write At least 6 months have been diagnosed with early onset and ongoing treatment They are being treated for high blood pressure Failure to participate in a co-effective study on study variables Having the right physical conditions to attend training sessions Ability to answer the phone Suffering Primary blood pressure Being Healthy Psychological Did not have history of CVA and MI Not having chronic diseases affecting quality of life All patients are under the supervision of a doctor 40 years 60 years Both Get extensive information about managing blood pressure from other sources or changing the treatment protocol Significant acute abnormalities and severe blood pressure or crisis Patient death I10 Essential (primary) hypertension Behavior Behavior Intervention group: After registration of patients who want to participate in research projects. The goals and the process of research will be explained to them. Patient's informed consent will be filled out. If they have inclusion criteria, they participate in the study. demographic information will be taken. This study was designed as a simple randomized controlled etrial with one-to-one allocation into two groups. The intervention group participated in the EASE program will be 35 and control group too.The EASE program in six steps is as follows for the intervention group: During step 1 of this program, information about the participant’s demographic characteristics, treatment plan, and examination data was gathered. The appropriateness of each patient’s medical care was confirmed, and participants were evaluated to ensure their psychological and physical preparedness. Client–professional relationship a major influence on healthcare behaviors (Interaction model) (First session). In Step 2, nurses encouraged participants to independently clarify issues related to their lifestyle and determine the self-management techniques needed for a healthier lifestyle (Express the positive and negative issues of lifestyle in relation to blood pressure), and Self-management approaches to improve healthy lifestyles (The factors and behaviors that reduce the blood pressure and its complications will be named and appropriate answers will be encouraged) ( Promotion model, Self efficacy) (second session). In Step 3, participants were involved in the setting of specific goals to foster self-efficacy and received support for their autonomous achievement of these goals, as enhanced self-efficacy is thought to lead to behavioral changes (Self efficacy, Promotion model) (second session). In step 4, techniques for achieving these goals were selected. In this study, self-monitoring was used to monitor the participants' actions and emotions toward their goals. The participants used self-monitoring techniques that involved monitoring of their actions and related benefits, which were logged using monitoring notes. Other techniques were added according to the participant’s condition; these included behavioral reinforcement and incremental goal achievement (action goals were set using small steps that initiated from achievable goals). Encouraging achievements, planning minor goals for achieving success and gaining positive experiences, encouraging verbal and nonverbal ways to increase repetition of behavior, creating optimism and hope for breakthroughs that will all enhance patient self-efficacy ( Promotion model, Self efficacy) (The third and fourth sessions). For Step 5, the nurses supported the participants' achievements of their action goals through interviews (fifth meeting) and phone or e-mail communication that patients will be contacted for 3-5 weeks every three days every 10 to 10 minutes, and guidance and encouragement will be used to strengthen positive behaviors and will support the achievements of the participants in achieving the desired goals (Promotion model, Self efficacy). For step 6: Achieving the desired goals will be evaluated. After eight weeks from the completion of the study, the variables will be re-evaluated as self-report at the clinic's meeting for re-examination (sixth session). 35 patients will be in control group. The control group won't participate in education sessions. The control group will receive routine education based on health centers program according to national protocols. At the first, control group will receive self-management, and self-monitoring of blood pressure questionnaires. Blood tests, Body Mass Index, blood pressure, will be measured too. After 3 months, the questionnaires, Clinical blood tests and BMI, blood pressure will be done again. Blood pressure. Timepoint: All variables at baseline and at the end of 3 months are evaluated. Method of measurement: Manometer. BMI. Timepoint: All variables at baseline and at the end of 3 months are evaluated. Method of measurement: Calibrated scale and meter. Nutritional status. Timepoint: All variables at baseline and at the end of 3 months are evaluated. Method of measurement: Questionnaire. Physical activity. Timepoint: All variables at baseline and then at the end of 3 months are evaluated. Method of measurement: Questionnaire. Paraclinic (Blood)tests: TG, cholestrol, Na of urine(24 hours). Timepoint: At baseline and at the end of 3 months are evaluated. Method of measurement: Labratory kits. Self-management behaviors. Timepoint: At the beginning of the study and 3 months after the study. Method of measurement: Likert questionnaire. Self-care behaviors. Timepoint: At the beginning of the study and 3 months after the study. Method of measurement: Likert questionnaire. Self-regulation behaviors. Timepoint: At the beginning of the study and 3 months after the study. Method of measurement: Likert questionnaire. Self-monitoring behaviors. Timepoint: At the beginning of the study and 3 months after the study. Method of measurement: Likert questionnaire. Response to the disease. Timepoint: At the beginning of the study and 3 months after the study. Method of measurement: Likert questionnaire. Training EASE program. Timepoint: During the 3 months of intervention. Method of measurement: Not. Hamedan University of Medical Sciences Approved 2018-09-26 Ethics committee of Hamadan University of Medical Sciences Hamadan University of Medical Sciences, Shahid Fahmideh Av, Hamadan, Iran. Hamedan Hamadan Iran (Islamic Republic of)