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IRCT20171216037895N3 IRCT 2019-06-04 Esfahan University of Medical Sciences The impact of empowerment on perceived threat and care burden in caregivers of spinal cord injury The effect of a program based on family-centered empowerment model on perceived threats and care burden in family carers of spinal cord injured patients 2019-03-01 anticipated 70 Complete https://irct.ir/trial/38721 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Among the injured and the caregivers who meet the inclusion criteria of the study, the caregiver is asked to randomly pick one of the two balls from the bag. People who pick the Ball 1 will be put into the intervention group and those who take the number 2 will be allocated to the control group. 3 Spinal cord injury. Intervention 1: Intervention group: In this group, the family-centered empowerment program is implemented through four steps. Step 1: the Perceived threats including perceived severity and perceived sensitivity. In perceived severity, related to the complications and risks of the disease, a questionnaire, having 14 questions and Likert responses will be used. Based on the results of this survey, for the five most common issues, five one-hour training sessions, along with discussion will be held in the group. Each group includes 9 people. Before the start of the first session, an examination on the provided care amount and the threat perceived by caregivers will be taken to compare the grades obtained in one and three months after the implementation of the family-centered empowerment program. In this section, the concepts are also provided to caregivers through pamphlets and booklets. For perceived sensitivity, a questionnaire having 14 questions, along with Likert responses will be used. At this part, in three one-hour sessions, the management of the anxiety, depression and the stress associated with the care of the patients injured in his/her spinal cord will be taught in group. The concepts in this section are also given to caregivers in using pamphlets and booklets. Step Two: This step is on improving self-efficacy through which caregivers are trained with practical skills. In a group session, and via problem solving method, caregivers' problems will be identified and prioritized, then solutions will be discussed by themselves. Each skill will then be taught in a practical way and will be taught taking self-efficacy steps. In three one-hour sessions, caregivers are provided with the method/s of controlling vital signs, physiotherapy of limbs and Kegel and Crede's exercises. The concepts in this section are also provided to caregivers through pamphlets and booklets. Step Three: This step is to increase self-esteem or self-confidence through educational participation. At this stage, caregivers are asked to convey the materials acquired through group discussion, as well as the lessons learnt on self-efficacy, into their own patients. Training cards, containing the materials presented in each session, will also be given to family caregivers to deliver to their patients. In case questions or problems raise, caregivers will write down the related questions and submit them or those of their patients to the nurses in the next sessions attending the center of the spinal cord injury. Given that patients may not be empowered through the training provided to family caregivers and studying the training cards, in order to discuss the materials provided by the family caregivers and what the patients have been learnt using the card, they and their family caregivers are invited to the center. Step Four: It includes process evaluation and the final assessment. To evaluate the process, at the beginning of each session, caregivers are asked to verbally respond to 5 questions on the concepts contained in the training session on the day the session held. The answers to this section will be compared at the end of the session. For the final evaluation, a written test will be carried out by the caregivers who will calculate the score of the care amount and perceived threat within one and three months after the intervention. Intervention 2: Control group: The same materials, i.e., the whole materials and their summary, are given to this group (like those provided for the intervention group) in two sessions. This group, as the same as the intervention group, will be evaluated at one and three months after the intervention. 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 There is no more information
public Ahmad Taheri Ghale-Salim
Hezarjarib
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 2918 a.taheri@nm.mui.ac.ir Esfahan University of Medical Sciences scientific ŮŽAhmad Taheri Ghale-salim
Hezarjarib
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 2918 a.taheri@nm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) The caregiver is required to be at least 18 and maximally 60 years old Have directly and actively taken care of a patient with spinal cord injury for at least 6 months and deserve to make decisions concerning the treatment of the injured person Have obtained the informed written consent for participation in the research Have no hearing or vision impairment for participation in the training sessions for caregiver Have reading literacy for caregiver Have no mental disorders or chronic physical illness and also have no history of taking medication and psychoactive substances for caregiver Have no history of participation in any training session or any research related to the subject of this study for caregiver Living the caregiver with a patient suffering from injured spinal cord injury Have obtained a Barthel Index (King's version) score less than and equal to 90 in Injured 18 years 60 years Both Having other acute or chronic physical disorders and psychological disorders in the caregiver Caregiver membership in the healthcare team T09.3 Injury of spinal cord, level unspecified Other Other Intervention group: In this group, the family-centered empowerment program is implemented through four steps. Step 1: the Perceived threats including perceived severity and perceived sensitivity. In perceived severity, related to the complications and risks of the disease, a questionnaire, having 14 questions and Likert responses will be used. Based on the results of this survey, for the five most common issues, five one-hour training sessions, along with discussion will be held in the group. Each group includes 9 people. Before the start of the first session, an examination on the provided care amount and the threat perceived by caregivers will be taken to compare the grades obtained in one and three months after the implementation of the family-centered empowerment program. In this section, the concepts are also provided to caregivers through pamphlets and booklets. For perceived sensitivity, a questionnaire having 14 questions, along with Likert responses will be used. At this part, in three one-hour sessions, the management of the anxiety, depression and the stress associated with the care of the patients injured in his/her spinal cord will be taught in group. The concepts in this section are also given to caregivers in using pamphlets and booklets. Step Two: This step is on improving self-efficacy through which caregivers are trained with practical skills. In a group session, and via problem solving method, caregivers' problems will be identified and prioritized, then solutions will be discussed by themselves. Each skill will then be taught in a practical way and will be taught taking self-efficacy steps. In three one-hour sessions, caregivers are provided with the method/s of controlling vital signs, physiotherapy of limbs and Kegel and Crede's exercises. The concepts in this section are also provided to caregivers through pamphlets and booklets. Step Three: This step is to increase self-esteem or self-confidence through educational participation. At this stage, caregivers are asked to convey the materials acquired through group discussion, as well as the lessons learnt on self-efficacy, into their own patients. Training cards, containing the materials presented in each session, will also be given to family caregivers to deliver to their patients. In case questions or problems raise, caregivers will write down the related questions and submit them or those of their patients to the nurses in the next sessions attending the center of the spinal cord injury. Given that patients may not be empowered through the training provided to family caregivers and studying the training cards, in order to discuss the materials provided by the family caregivers and what the patients have been learnt using the card, they and their family caregivers are invited to the center. Step Four: It includes process evaluation and the final assessment. To evaluate the process, at the beginning of each session, caregivers are asked to verbally respond to 5 questions on the concepts contained in the training session on the day the session held. The answers to this section will be compared at the end of the session. For the final evaluation, a written test will be carried out by the caregivers who will calculate the score of the care amount and perceived threat within one and three months after the intervention. Control group: The same materials, i.e., the whole materials and their summary, are given to this group (like those provided for the intervention group) in two sessions. This group, as the same as the intervention group, will be evaluated at one and three months after the intervention. Severity of perceived threat. Timepoint: One and three months after the intervention. Method of measurement: Questionnaire. Burden of care. Timepoint: One and three months after the intervention. Method of measurement: Questionnaire. Esfahan University of Medical Sciences Approved 2019-02-27 Ethics Committee of Isfahan University of Medical Sciences Hezarjarib Isfahan Isfehan Iran (Islamic Republic of)