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IRCT2017071835170N1 IRCT 2017-07-29 Faculty of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences The effect of Family-Centered Empowerment Model in stroke The effect of Family-Centered Empowerment Model implementation on family caregivers’ burden and ability to perform daily living activities of hospitalized patients with stroke in selected teaching hospitals of Shahid Beheshti University of Medical Sciences 2017-12-26 anticipated 90 Complete https://irct.ir/trial/26657 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive. N/A Stroke. Intervention 1: Intervention group: Implementation of family-centered empowerment model for family caregivers in the intervention group, in 4 sessions of two hours and in 4 consecutive days during the hospitalization of the patient in the classroom in the ward. The following is a detailed description of the interventions of each step in this model. o The first step (to increase the perceived threat): At this stage, the perceived threat of family caregivers will increase, through the mechanism of perceived susceptibility and perceived severity with increasing knowledge and attitudes towards stroke, the risk and its complications for family members. Accordingly the researcher will explain educational materials to the family caregiver including the importance of stroke, definition, symptoms, risk factors, prevention, treatment, complications and the proper care of patients focused on providing the solutions to enhance the ability to perform daily activities of life (personal grooming, bathing, eating, toilet and purity, going up and down stairs, getting dressed, bowel control, bladder control, gait and mobility) face to face and through methods lectures, discussion of questions and answers, Using the educational slides and practical illustrations, during two 2-hour sessions in 2 consecutive days. The perceived threat of family caregivers before, immediately, 2 weeks, and 2 months after the implementation of the family-centered empowerment model will be examined by the researcher-made questionnaire of perceived threat. O The second step (increasing self-efficacy): At this stage, self-efficacy and a sense of control over the conditions in the caregiver will be enhanced through problem-solving. Researcher and caregive will have a face-to-face consultation and discussion session during a two-hour meeting. At this stage, family caregivers are faced with their problems and the process of problem solving, and will be discussed by the researcher, with objective examples of their own situation and what to do to improve the similar problem. So they can learn skills needed to find solutions and apply the problem solving process. Self-efficacy of family caregivers will be examined before, immediately, 2 weeks and 2 months after the implementation of the family-centered empowerment model by the general self-efficacy scale-10. O Step Three (Increasing self-esteem): At this stage, self-esteem will be promoted through collaborative education. It should be noted that in implementing this step from the family-centered empowerment model, learning to increase self-esteem is considered. So, the pamphlets and educational package will be provided to family caregivers, and he/she will be asked to provide a summary of the lessons taught and in a simple and understandable say to the patient family member during the two-hour session in the presence of the researcher. In this way, the researcher will implement a strategy to increase self-esteem in family caregivers and ensure the accuracy of learning the contents taught in previous steps. The family caregiver is also requested to explain again educational package to the patient in the first week of discharge. At the end of the session. Self-esteem of family caregivers will be examined before, immediately, 2 weeks and 2 months after the implementation of the family-centered empowerment model by Rosenberg Self-esteem Scale. O Step four (Evaluation): This step of the model will be carried out in two ways: the process evaluation (process evaluation is evaluation of the steps of model mentioned above including the evaluation of the effectiveness of implementing family-centered empowerment model on perceived threat, self-efficacy, self-esteem and health locus of control of family caregivers) and the final evaluation. The final evaluation is also evaluation the effect of implementing the family-centered empowerment model on family caregivers' burden and the ability to perform activities of daily life in patients with stroke before, immediately, 2 weeks, and 2 months after full implementation of the model steps. Intervention 2: Control group: there are no interventions in this group. Measures for measuring the variables of the research will be carried out as in the intervention group.
public Narjes Deyhoul
Valiasr Street intersection of Niayesh across the Shahid Rajaei Hospital
Tehran Iran (Islamic Republic of) +98 21 8865 5366 narges.deyhoul@sbmu.ac.irnarges.dyhl@gmail.com Faculty of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences scientific Parvaneh Vasli
Valiasr Street intersection of Niayesh across the Shahid Rajaei Hospital
Tehran Iran (Islamic Republic of) +98 21 8865 5366 p-vasli@sbmu.ac.irparvanehvasli@yahoo.com Faculty of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Patient entry criteria: 1. Having stroke. 2. disability degree of 3, 4 or 5 in accordance with the standard Rankin scale. 3. Educability. 4. Age 45 years and up. 5. Hospital admission for at least 4 days. 6. Transfer to the home after discharge and being under the care of the family care provider. Family caregiver entry criteria: 1. Lack of previous care of another patient with chronic illness. 2. Not having academic education in the field of medical science in the caregiver or other family members of the patient. 3. Age 18 years old and up. 4. Having reading and writing skills and ability to speak Persian 5. Calling possibility. Patient exit criteria: 1. Readmission or death of the patient before the final evaluation. 2. Not participating in implementation of the education participatory step of family-centered empowerment model. 3. Receiving an educational program except the normal schedule of the hospital during the study period. Family caregiver exit criteria: 1. Changing of the family caregiver. 2. Lack of regular participation in the implementation of family-center empowerment model steps. 3. Receiving an educational program except the normal schedule of the hospital during the study period. 45 years 99 years Both I64 Stroke, not specified as haemorrhage or infarction Lifestyle N/A Intervention group: Implementation of family-centered empowerment model for family caregivers in the intervention group, in 4 sessions of two hours and in 4 consecutive days during the hospitalization of the patient in the classroom in the ward. The following is a detailed description of the interventions of each step in this model. o The first step (to increase the perceived threat): At this stage, the perceived threat of family caregivers will increase, through the mechanism of perceived susceptibility and perceived severity with increasing knowledge and attitudes towards stroke, the risk and its complications for family members. Accordingly the researcher will explain educational materials to the family caregiver including the importance of stroke, definition, symptoms, risk factors, prevention, treatment, complications and the proper care of patients focused on providing the solutions to enhance the ability to perform daily activities of life (personal grooming, bathing, eating, toilet and purity, going up and down stairs, getting dressed, bowel control, bladder control, gait and mobility) face to face and through methods lectures, discussion of questions and answers, Using the educational slides and practical illustrations, during two 2-hour sessions in 2 consecutive days. The perceived threat of family caregivers before, immediately, 2 weeks, and 2 months after the implementation of the family-centered empowerment model will be examined by the researcher-made questionnaire of perceived threat. O The second step (increasing self-efficacy): At this stage, self-efficacy and a sense of control over the conditions in the caregiver will be enhanced through problem-solving. Researcher and caregive will have a face-to-face consultation and discussion session during a two-hour meeting. At this stage, family caregivers are faced with their problems and the process of problem solving, and will be discussed by the researcher, with objective examples of their own situation and what to do to improve the similar problem. So they can learn skills needed to find solutions and apply the problem solving process. Self-efficacy of family caregivers will be examined before, immediately, 2 weeks and 2 months after the implementation of the family-centered empowerment model by the general self-efficacy scale-10. O Step Three (Increasing self-esteem): At this stage, self-esteem will be promoted through collaborative education. It should be noted that in implementing this step from the family-centered empowerment model, learning to increase self-esteem is considered. So, the pamphlets and educational package will be provided to family caregivers, and he/she will be asked to provide a summary of the lessons taught and in a simple and understandable say to the patient family member during the two-hour session in the presence of the researcher. In this way, the researcher will implement a strategy to increase self-esteem in family caregivers and ensure the accuracy of learning the contents taught in previous steps. The family caregiver is also requested to explain again educational package to the patient in the first week of discharge. At the end of the session. Self-esteem of family caregivers will be examined before, immediately, 2 weeks and 2 months after the implementation of the family-centered empowerment model by Rosenberg Self-esteem Scale. O Step four (Evaluation): This step of the model will be carried out in two ways: the process evaluation (process evaluation is evaluation of the steps of model mentioned above including the evaluation of the effectiveness of implementing family-centered empowerment model on perceived threat, self-efficacy, self-esteem and health locus of control of family caregivers) and the final evaluation. The final evaluation is also evaluation the effect of implementing the family-centered empowerment model on family caregivers' burden and the ability to perform activities of daily life in patients with stroke before, immediately, 2 weeks, and 2 months after full implementation of the model steps. Control group: there are no interventions in this group. Measures for measuring the variables of the research will be carried out as in the intervention group. Ability to do daily life activities. Timepoint: Before intervention, immediately after intervention, 2 weeks after intervention, 2 months after intervention. Method of measurement: Barthel Index. Burden of care. Timepoint: Before intervention, immediately after intervention, 2 weeks after intervention, 2 months after intervention. Method of measurement: Novak & Guest Caregiver Burden Inventory. Perceived threat. Timepoint: Before intervention, immediately after intervention, 2 weeks after intervention, 2 months after intervention. Method of measurement: Researcher-made Questionnaire of Perceived Threat. Self-efficacy. Timepoint: Before intervention, immediately after intervention, 2 weeks after intervention, 2 months after intervention. Method of measurement: General Self Efficacy-10. Self-Esteem. Timepoint: Before intervention, immediately after intervention, 2 weeks after intervention, 2 months after intervention. Method of measurement: Rosenberg Self_Esteem Scale. Health Locus of Control. Timepoint: Before intervention, immediately after intervention, 2 weeks after intervention, 2 months after intervention. Method of measurement: Multidimensional Health Locus of Control scale. Faculty of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences Approved 2016-05-16 Shahid Beheshti University of Medical Sciences Ethics committee Valiasr Street intersection of Niayesh across the Shahid Rajaei Hospital Tehran Iran (Islamic Republic of)