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IRCT20150919024080N21 IRCT 2022-02-20 Khoram-Abad University of Medical Sciences The Effect of Multidisciplinary Brief Intervention on Reduction of Cardio- Metabolic Risk Factors The Effect of Multidisciplinary Brief Intervention on Reduction of Cardio- Metabolic Risk Factors in Women Admitted to the Emergency Department 2022-02-20 anticipated 110 Complete https://irct.ir/trial/55526 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In order to unify the important distribution of age and education, class based on these variables related to pre menopause/post menopause, a diploma/ high diploma, and then a block random method (Block randomization) in two studies groups are balanced. It should be noted that the volume of each block is 4, which makes six different combinations of block (4 blocks) and choose random selection by placing blocks. Using this method the sample volume will be equal to the two study arms and the difference between the two groups in terms of sample volume will be equivalent to half the block, Blinding description: Blinding groups as a ( intervention group ) and b ( control group ) are performed by a nursing that does not play a role in the study. The code occasionally runs to the independent nurse until the end of the data analysis. Data analyst and evaluation nurse are unaware of the random allocation of groups in the control and intervention groups. Participants prior to randomization become aware of their possible allocation in one of the control and intervention groups. N/A Cardio-metabolic syndrome. Intervention 1: Intervention group: Intervention group: After accepting the patient in the emergency department and choosing the sample based on the criterion of entry into intervention, a brief intervention takes place in this form.The intervention is focused on three components of the motivational interview , the motivational counseling and motivational counseling of the physical activity , including three individual visits and three phone calls .which is being offered by a multi - professional team within eight weeks includes medical professionals , trained nurses about motivational interviewing ( senior undergraduate , main researcher ) as well as a nutritionist .The intervention program contains the intervention program for three individual visits and three phone follow - up, as described below. First visit to the evocative interview• : taking a history of the client and determining risk factors are done by findrisk questionnaire . Then the evocative interview is performed according to the frames model considering six steps including feedback , responsibility , recommendation , list of options , empathy , and work . Second visit to the feeding motivational counseling: the face visit to the second one ( according to the patient 's desire ) after the first visit was done by the nutritionist and by the presence of the main researcher and preferably the patient 's family for a period of thirty - eight minutes . the question about the eating habits of the patient and family , the initial assessment of the patient 's nutritional status , weight and eating disorder and providing explanations concerning the intake of a healthy diet and the importance of food intake , explanation and interpretation of the food label are the contents of this visit . A third visit to the motivational orientation of the physical activity: A third - to - face visit lasts from 6 to 24 hours ( according to the patient " s inclination ) after the second visit , by the principal investigator , and with the presence of the team physician and preferably the patient " s family , for 20 - 30 minutes . The question about the physical activity of the patient and the family is to explore the condition of physical activity, weight and physical barriers, explain the importance and benefits of physical activity, disadvantages of non - mobility, types of exercises and exercises, as well as planning to consider the barriers to physical activity and provide a "safe and healthy life" to the patient. Early motivational follow - up two weeks after patient release from the hospital, phone calls to the patient can be increased by the researcher for an average of 10 minutes (as per the patient " s need).This call involves reviewing the feedback, reviewing the progress of the new incentive for change, reviewing behavioral changes (to increase physical activity and adherence to a healthy diet)and any positive change, an assessment of commitment to change behavior, monitoring the condition of eating and physical activity, motivating to return to the behaviors or lifestyle of prior unhealthy lifestyle and review of the training booklet. The second motivational follow - up of four weeks after the patient "s release from the hospital, the patient" s phone call can be eligible for an average of 10 minutes (as per the patient " s need). The content and purpose of this contact is similar to the first telephone follow - up . A third - week motivational follow - up week after patient release from the hospital, the patient "s phone call can be eligible for an average of 10 minutes (as per the patient" s need). the content and purpose of this call is similar to the first or second phone calls . " Changing a Woman for Healthy and Healthy Life " booklet aims to remind evocative interviews , foster healthy behaviors , as well as provide supplementary training . The contents of the booklet include : a simple explanation for the definition of cardiovascular risk factors , symptoms and effects of risk factors , risk factors of cardiovascular risk , metabolic inequalities , and their relevance to cardiovascular health , risk reduction in women and eating disorders , introducing well - known Iranian women with healthy lifestyles , healthy eating and physical activity . Intervention 2: Control group:The control group in the emergency department receive regular emergency care and receive a routine training exercise on the patient " s illness on the day of their routine training and on patient requests . In order to observe the ethical principles , it will be sent to the post - mail address to control the manual after the intervention is over . 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 Zahra Bazgir
Kheirabad
Khorramabad Iran (Islamic Republic of) 6814717361 +98 66 3340 7189 zahrabazgir70@yahoo.com Khoram-Abad University of Medical Sciences scientific Mohammad Gholami
Integrated Lorestan Medical, Opposite to the Kahrizak Village, km 5 Road of Khorram Abad ,Boroujerd
khorramabad Iran (Islamic Republic of) 6814993165 +98 912 509 1279 gholami.m@lums.ac.ir Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Women with metabolic heart disease aged 18 - 75 Patient with moderate to high risk and with two risk factor of cardiometabolic according to risk assessment scale (prediabetic situation or metabolic syndrome) Exposure in the level of 3, 4, 5 ESI triage Ability to understand andperception Persian language Willingness and consent to participate in research and to complete the form of research ethics Admission and accommodation in the emergency department for at least 24 hours and having a medical record Psychological disorder, such as severe mood disorders BMI>27 (in the weight of overweight and obese) On average , more than 60 minutes per week physical activity (moderate and severe) has occurred over the past three months Having a fixed phone or cell phone 18 years 75 years Female getting with a severe psychological illness after the diagnosis of the disease. the present experience of cardiovascular disease like dyspnea or tachycardia Chronic diseases such as renal failure , liver failure getting viral disease and acute infected disease such as covid 19 Patients at the risk of suicide according to the Nurses Global Assessment of Suicide Risk criteria . Heart Rate<60 AND Heart Rate>100 Systolic Blood Pressure>160 AND Diastolic Blood Pressure>100 Engagement in other counseling programs and changing behavior for lifestyle hospitalization for more than a week E88.81 Metabolic syndrome Behavior Other Intervention group: Intervention group: After accepting the patient in the emergency department and choosing the sample based on the criterion of entry into intervention, a brief intervention takes place in this form.The intervention is focused on three components of the motivational interview , the motivational counseling and motivational counseling of the physical activity , including three individual visits and three phone calls .which is being offered by a multi - professional team within eight weeks includes medical professionals , trained nurses about motivational interviewing ( senior undergraduate , main researcher ) as well as a nutritionist .The intervention program contains the intervention program for three individual visits and three phone follow - up, as described below. First visit to the evocative interview• : taking a history of the client and determining risk factors are done by findrisk questionnaire . Then the evocative interview is performed according to the frames model considering six steps including feedback , responsibility , recommendation , list of options , empathy , and work . Second visit to the feeding motivational counseling: the face visit to the second one ( according to the patient 's desire ) after the first visit was done by the nutritionist and by the presence of the main researcher and preferably the patient 's family for a period of thirty - eight minutes . the question about the eating habits of the patient and family , the initial assessment of the patient 's nutritional status , weight and eating disorder and providing explanations concerning the intake of a healthy diet and the importance of food intake , explanation and interpretation of the food label are the contents of this visit . A third visit to the motivational orientation of the physical activity: A third - to - face visit lasts from 6 to 24 hours ( according to the patient " s inclination ) after the second visit , by the principal investigator , and with the presence of the team physician and preferably the patient " s family , for 20 - 30 minutes . The question about the physical activity of the patient and the family is to explore the condition of physical activity, weight and physical barriers, explain the importance and benefits of physical activity, disadvantages of non - mobility, types of exercises and exercises, as well as planning to consider the barriers to physical activity and provide a "safe and healthy life" to the patient. Early motivational follow - up two weeks after patient release from the hospital, phone calls to the patient can be increased by the researcher for an average of 10 minutes (as per the patient " s need).This call involves reviewing the feedback, reviewing the progress of the new incentive for change, reviewing behavioral changes (to increase physical activity and adherence to a healthy diet)and any positive change, an assessment of commitment to change behavior, monitoring the condition of eating and physical activity, motivating to return to the behaviors or lifestyle of prior unhealthy lifestyle and review of the training booklet. The second motivational follow - up of four weeks after the patient "s release from the hospital, the patient" s phone call can be eligible for an average of 10 minutes (as per the patient " s need). The content and purpose of this contact is similar to the first telephone follow - up . A third - week motivational follow - up week after patient release from the hospital, the patient "s phone call can be eligible for an average of 10 minutes (as per the patient" s need). the content and purpose of this call is similar to the first or second phone calls . " Changing a Woman for Healthy and Healthy Life " booklet aims to remind evocative interviews , foster healthy behaviors , as well as provide supplementary training . The contents of the booklet include : a simple explanation for the definition of cardiovascular risk factors , symptoms and effects of risk factors , risk factors of cardiovascular risk , metabolic inequalities , and their relevance to cardiovascular health , risk reduction in women and eating disorders , introducing well - known Iranian women with healthy lifestyles , healthy eating and physical activity . Control group:The control group in the emergency department receive regular emergency care and receive a routine training exercise on the patient " s illness on the day of their routine training and on patient requests . In order to observe the ethical principles , it will be sent to the post - mail address to control the manual after the intervention is over . Cardiometabolic risk. Timepoint: Before starting treatment and after completing the 60 day treatment period. Method of measurement: FINDRISK tool. Physical activity. Timepoint: Before starting treatment and after completing the 60 day treatment period. Method of measurement: Short International Physical Activity questionnaire. Mediterranean diet score. Timepoint: Before starting treatment and after completing the 60 day treatment period. Method of measurement: Modified Mediterranean diet score questionnaire. Khoram-Abad University of Medical Sciences Approved 2021-03-10 Lorestan Medical Sciences Ethics Committee Lorestan University of Medical Sciences, Campus Kamalvand, Vice Chancellor for Research and Technology, Khorramabad, Lorestan Khorramabad Lorestan Iran (Islamic Republic of)