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IRCT20201016049043N1 IRCT 2020-11-21 Zahedan University of Medical Sciences The effect of family-based empowerment model in hypertensive patients Studying the effect of family-based empowerment model on self-efficacy and quality of life in hypertensive patients visiting comprehensive health centers 2020-08-22 anticipated 70 Complete https://irct.ir/trial/51746 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Sampling will be done in several stages. First, urban areas are considered as clusters, then two areas are randomly selected, and then from each area, a center is identified by drawing a number, and the centers are allocated to intervention or control by drawing a number. Samples from selected centers will then be selected simply and consecutively and based on inclusion criteria. N/A Hypertension. Intervention 1: Intervention group: Family-centered empowerment based on steps or pattern according to the training program designed for each group in 4 60-minute sessions for 4 weeks individually, with the active participation of the patient and a family member (at least the main caregiver of the family) in the form of discussion and questions and answers will be done by the researcher in a suitable place for training in comprehensive health centers and preferably during office hours using teaching aids such as PowerPoint, educational videos and educational booklets and the control group will not receive any training. Step 1 (Understanding the threat): The first step in the family-centered empowerment model is to increase the intensity and sensitivity perceived in order to sensitize and raise the level of information of patients and their families through lectures and discussions about the nature and complications of the disease, aggravating factors Disease, nutritional factors, exercise and effective factors in disease control will be implemented. At the end of the training session, questions and answers will be done to ensure the understanding of the content. Step 2 (Self-Efficacy): At this stage, problem solving or problem solving will be implemented. For this purpose, problem solving sessions (two 60-minute sessions) will be held individually for patients and their families. In these sessions, patients and families will be confronted with problems and the problem-solving process, and will be asked to discuss concrete examples of their situation and what they have done to improve the problem. Also in this session, practical methods of measuring weight and blood pressure (in detail) and the consequences of not controlling these two variables and its normal amount will be explained. Patients and families will then be asked to practice this skill. At this stage, the best way to solve patients' problems will be selected and the client's skills will be emphasized. Step 3 (self-confidence and increase self-confidence): At this stage, the patient will be asked to teach the family the issues raised in the previous sessions during the session with the help of the researcher, and if help and guidance is needed, the researcher will do this. The purpose of this step is to increase patients' self-confidence due to their ability to provide information to family members and family support. To ensure and follow up on this step, a number of questions related to the training issues will be given to the patient to complete with family members and submit to the researcher (one week). Step 4 (Evaluation): Process evaluation during the process Intervention in all sessions will be done with questions and answers about the items mentioned in the previous sessions. The final evaluation will be done one and three months after the intervention in the two groups by completing the questionnaires of quality of life and self-efficacy. Also, during the research, the researcher will be in contact with the research units by phone in order to solve possible problems and questions. Intervention 2: Control group: Get routine care.In terms of observing ethical issues at the end of the intervention, an educational booklet based on valid scientific texts will be prepared under the supervision of experts in this field and will be provided to participants in both intervention and control groups. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals. Questionnaires containing information of patients in this study, including age, sex and any other information that is collected and analyzed are available. When: Access 5 months after the end of the intervention To whom: Researchers working in academic and scientific institutionوابسته به سازمان معتبر باشدs Conditions: Be affiliated with a reputable organization Where to obtain: email: mahsaa.asadollahi@gmail.com How to obtain: Send message via email and receive a reply within 7 working days Comments:
public Dr Alireza Salar
School of Nursing and Midwifery, Mashahir square; Zahedan
Zahedan Iran (Islamic Republic of) 9816913396 +98 54 3344 2482 salar293@gmail.com Zahedan University of Medical Sciences scientific Dr Alireza Salar
School of Nursing and Midwifery, Mashahir square; Zahedan
Zahedan Iran (Islamic Republic of) 9816913396 +98 54 3344242 salar293@gmail.com Zahedan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Diagnosed high blood pressure from at least 6 months ago Caregiver has at least reading and writing literacy Being at the age of 25-65 years old 25 years 65 years Both Participating in a training program similar to the current training program during the last 6 months I10 Essential (primary) hypertension N/A N/A Intervention group: Family-centered empowerment based on steps or pattern according to the training program designed for each group in 4 60-minute sessions for 4 weeks individually, with the active participation of the patient and a family member (at least the main caregiver of the family) in the form of discussion and questions and answers will be done by the researcher in a suitable place for training in comprehensive health centers and preferably during office hours using teaching aids such as PowerPoint, educational videos and educational booklets and the control group will not receive any training. Step 1 (Understanding the threat): The first step in the family-centered empowerment model is to increase the intensity and sensitivity perceived in order to sensitize and raise the level of information of patients and their families through lectures and discussions about the nature and complications of the disease, aggravating factors Disease, nutritional factors, exercise and effective factors in disease control will be implemented. At the end of the training session, questions and answers will be done to ensure the understanding of the content. Step 2 (Self-Efficacy): At this stage, problem solving or problem solving will be implemented. For this purpose, problem solving sessions (two 60-minute sessions) will be held individually for patients and their families. In these sessions, patients and families will be confronted with problems and the problem-solving process, and will be asked to discuss concrete examples of their situation and what they have done to improve the problem. Also in this session, practical methods of measuring weight and blood pressure (in detail) and the consequences of not controlling these two variables and its normal amount will be explained. Patients and families will then be asked to practice this skill. At this stage, the best way to solve patients' problems will be selected and the client's skills will be emphasized. Step 3 (self-confidence and increase self-confidence): At this stage, the patient will be asked to teach the family the issues raised in the previous sessions during the session with the help of the researcher, and if help and guidance is needed, the researcher will do this. The purpose of this step is to increase patients' self-confidence due to their ability to provide information to family members and family support. To ensure and follow up on this step, a number of questions related to the training issues will be given to the patient to complete with family members and submit to the researcher (one week). Step 4 (Evaluation): Process evaluation during the process Intervention in all sessions will be done with questions and answers about the items mentioned in the previous sessions. The final evaluation will be done one and three months after the intervention in the two groups by completing the questionnaires of quality of life and self-efficacy. Also, during the research, the researcher will be in contact with the research units by phone in order to solve possible problems and questions. Control group: Get routine care.In terms of observing ethical issues at the end of the intervention, an educational booklet based on valid scientific texts will be prepared under the supervision of experts in this field and will be provided to participants in both intervention and control groups. Self-efficacy score in the specific self-efficacy questionnaire of hypertensive patients. Timepoint: At the beginning of the study (before the intervention) and 1 month and 3 months after the intervention. Method of measurement: Specific self-efficacy of hypertensive patients questionnaire. Quality of life score in the quality of life questionnaire specific to hypertensive patients. Timepoint: Measurement of quality of life at the beginning of the study (before the intervention) and 1 month and 3 months after the intervention. Method of measurement: Quality of life questionnaire specific to hypertensive patients. Zahedan University of Medical Sciences Approved 2020-08-10 Ethics committee of Zahedan University of Medical Sciences Medical Sciences Campus, Dr. Hesabi square, Zahedan Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)