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IRCT20200530047596N1 IRCT 2020-06-08 Hamedan University of Medical Sciences The effect of family-centered empowerment education model on quality of life of women with stroke and their caregivers The effect of family-centered empowerment education model on quality of life of menopausal women with stroke and their caregivers 2020-06-21 anticipated 88 Complete https://irct.ir/trial/48512 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients randomly assigned to the intervention and control groups by using 4 random blocks will be conducted.The randomization unit is the individual. For this purpose, before the intervention, a random allocation sequence will be determined by one of the researchers. The sequence is determined so that the states of the 4 blocks, which are 6 states (AABB-ABAB - BBAA-BABA-ABBA-BAAB) are written on paper and randomly removed 22 times (88 samples) by replacement and The order is recorded. Group A will be the intervention group and B will be the control group. The prepared sequence remains with the researcher and then, when performing the intervention, it is presented to the other researcher who is not aware of the sequence (concealment), Blinding description: First, the goals of the study are explained to the patient, and then, in dealing with each sample, the patient is randomly assigned to a group.Then the intervention is done and the questionnaires are completed. Finally, the data will be analyzed by the analyst without specifying the type of group. N/A Stroke, not specified as haemorrhage or infarction. Intervention 1: Control group: There are no interventions in this group. Intervention 2: Intervention group: Intervention group: Implementation of family-centered empowerment model for patients and family caregivers in the intervention group, in 4 sessions of one hours and in 4 consecutive days while the patient is hospitalized in the ward. The duration of each session is 1 hour, which will be provided according to the educational needs and patient tolerance during the day (depending on the circumstances, it may take longer). The first step (to increase the perceived threat): The first step in a family-centered empowerment model is to increase the perceived threat of the empowering agent, the family system, consisting of the client and his or her family. The perceived threat includes perceived sensitivity and perceived intensity. To increase a person's level of perceived threat to the disease, his or her perceived sensitivity and severity to the disease, complications, and treatment process must be increased. n order to increase the perceived threat, it is used by lecturing and questioning based on the objectives of this step. The content of this step includes information about the importance, definition, symptoms, risk factors, prevention, care and treatment of stroke. Which is performed by one of the researchers. Step 2 / Session 2 (Improving Self-Efficacy by Problem Solving): To improve self-efficacy, a problem-solving training session is held. So that the possible or existing problems of the patient and the main caregiver are identified, defined and the solutions are presented, discussed and prioritized by themselves. Then, important and skillful problems are practically taught by practical demonstration method. Patients and caregivers are given the opportunity to practice and repeat activities to the extent that they are able to do so without the presence of their researcher. Step 3 / Session 3 (Increasing Self-Confidence by Educational Participation Method): The researcher designs the educational participation stage in such a way that the patient and his / her caregiver actively participate in the project. In this step, the topics discussed in the previous sessions and a summary of the educational pamphlets are passed on to other family members by the primary caregiver. The main caregiver's activity is also evaluated. The primary caregiver is also asked to teach the patient during the week after discharge. Step 4 (Evaluation): This step involves two types of evaluation. Process evaluation and final evaluation. Process evaluation will be performed at the end of each step. Thus, in the first stage, in order to evaluate the perceived threat with the oral question from the patient and the main caregiver, in the second stage, to evaluate the self-efficacy, by requesting to show or perform the skill related to using the skill by the patient and the main caregiver and the third step in assessing self-esteem (self-confidence) is by examining the level of cooperation of the primary caregiver in educational participation. In order to finally evaluate the family-centered empowerment model on the fourth day, all three previous steps are re-evaluated. 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 It is not yet known if there will be a plan to make this available
public Zahra Pourfarzad
Shahid Fahmideh
Hamadan Iran (Islamic Republic of) 65167-19657 0098813250182 purfarzad7@yahoo.com Hamedan University of Medical Sciences scientific Mansoureh Refaei
Shahid Fahmideh
Hamadan Iran (Islamic Republic of) 65167-19657 +98 81 3838 0150 mansourehrefaei@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Patient inclusion criteria: Hospitalization due to stroke Willingness to participate in the study Be alert Having hearing health More than 48-72 hours have passed since the stroke (passed the acute stage) The patient's level of disability is moderate and mild (based on the Bartel index) Be woman Be menopause More than 40 years old Family caregiver inclusion criteria: Age 18 years old and up Should not have psychological problems Having reading and writing skills and ability to speak Persian 40 years no limit Both Patient exclusion criteria:The patient's physical and mental condition is acute Inability to communicate Family caregiver exclusion criteria: Receiving an educational program except the normal schedule of the hospital Lack of regular participation in the implementation of family-center empowerment model steps G46.4 Cerebellar stroke syndrome N/A Lifestyle Control group: There are no interventions in this group. Intervention group: Intervention group: Implementation of family-centered empowerment model for patients and family caregivers in the intervention group, in 4 sessions of one hours and in 4 consecutive days while the patient is hospitalized in the ward. The duration of each session is 1 hour, which will be provided according to the educational needs and patient tolerance during the day (depending on the circumstances, it may take longer). The first step (to increase the perceived threat): The first step in a family-centered empowerment model is to increase the perceived threat of the empowering agent, the family system, consisting of the client and his or her family. The perceived threat includes perceived sensitivity and perceived intensity. To increase a person's level of perceived threat to the disease, his or her perceived sensitivity and severity to the disease, complications, and treatment process must be increased. n order to increase the perceived threat, it is used by lecturing and questioning based on the objectives of this step. The content of this step includes information about the importance, definition, symptoms, risk factors, prevention, care and treatment of stroke. Which is performed by one of the researchers. Step 2 / Session 2 (Improving Self-Efficacy by Problem Solving): To improve self-efficacy, a problem-solving training session is held. So that the possible or existing problems of the patient and the main caregiver are identified, defined and the solutions are presented, discussed and prioritized by themselves. Then, important and skillful problems are practically taught by practical demonstration method. Patients and caregivers are given the opportunity to practice and repeat activities to the extent that they are able to do so without the presence of their researcher. Step 3 / Session 3 (Increasing Self-Confidence by Educational Participation Method): The researcher designs the educational participation stage in such a way that the patient and his / her caregiver actively participate in the project. In this step, the topics discussed in the previous sessions and a summary of the educational pamphlets are passed on to other family members by the primary caregiver. The main caregiver's activity is also evaluated. The primary caregiver is also asked to teach the patient during the week after discharge. Step 4 (Evaluation): This step involves two types of evaluation. Process evaluation and final evaluation. Process evaluation will be performed at the end of each step. Thus, in the first stage, in order to evaluate the perceived threat with the oral question from the patient and the main caregiver, in the second stage, to evaluate the self-efficacy, by requesting to show or perform the skill related to using the skill by the patient and the main caregiver and the third step in assessing self-esteem (self-confidence) is by examining the level of cooperation of the primary caregiver in educational participation. In order to finally evaluate the family-centered empowerment model on the fourth day, all three previous steps are re-evaluated. Patient quality of life. Timepoint: Before intervention , 2 month after intervention. Method of measurement: Strocke Specific-Quality of Life Scale. Family care giver quality of life. Timepoint: Before intervention , 2 month after intervention. Method of measurement: Short Form-36 (SF-36) questionnaire. Hamedan University of Medical Sciences Approved 2020-05-23 Ethics committee of Hamadan University of Medical Sciences Shahid Fahmideh Hamadan Hamadan Iran (Islamic Republic of)