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IRCT20120804010488N3 IRCT 2018-04-25 Brain and spinal cord injury reseach center The effect of family-centered empowerment model on persons with SCI on quality of life and health behaviors Evaluating the effect of family-centered empowerment model on persons with SCI on quality of life and health behaviors 2018-04-16 anticipated 48 Complete https://irct.ir/trial/10984 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Those who evaluate the outcome (statistician) do not know which data belongs to which of the two control or test groups, Randomization description: Initially, profiles of people with spinal cord injury are reviewed, which are in Brain and spinal cord research center and the telephone numbers of eligible individuals are written. individual with SCI are invited to the Research Center for initial assessment in accordance with the Consort flowchart. It should be noted that subjects are divided into two groups according to the randomization table. The researcher does not have any interference with which group to which it belongs, Blinding description: the one who evaluates the outcome (statistician) dose not know which data belongs to which of the two control or test groups. N/A Individual with Spinal Cord Injury (Paraplegia). Intervention 1: Intervention group: are individuals with spinal cord injury and their family caregivers. Interventions include the pre-test, multiple educational interventions through two sessions of the classroom, instructional films (physical empowerment in person with SCI), instruction booklet ( include physical, mental and psychological care tips for a person with SCI and their caregivers), education by telegram and follow up by telephone, run post tests one month later and three months later. Intervention 2: Control group: person with spinal cord injury and their family caregivers that they receive rehabilitation routine programs. Yes - There is a plan to make this available What will be shared: It is going to publish of study' s results. When: Start the access period from 1398 To whom: Only for researchers working in academic and scientific institutions will be available. Conditions: Record the information in this dissertation and usable for the next study Where to obtain: The Central Library in Tehran University of Medical Sciences How to obtain: Refer the Central Library of Tehran University of Medical Sciences and study the dissertation using a valid ID card. Comments:
public Maryam Shabany
Brain and Spinal cord injury, Neurosciences institute, Tehran University of Medical Sciences, Tehran, Iran
Tehran Iran (Islamic Republic of) 14419733139 +98 21 6658 1560 mshabani@razi.tums.ac.ir Tehran University of Medical Sciences scientific Dr. Alireza Nikbakht Nasrabadi
Satarkhan
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6690 4252 nikbakht@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria for Individual with Spinal Cord Injury (SCI): Participants who had spinal cord injury from type of paraplegia by the diagnosis of a specialist physician those who had age of more than 18 years those who had spinal cord injury more than one year and less than 5 years those who had mental and cognitive ability those who had the ability to read and write Inclusion criteria for family caregivers: Participants who were family caregiver that being aware of the Individual with SCI’s condition those who were not a member of the medical team those who had mental and cognitive ability those who had ability for reading and writing 18 years no limit Both Participants who had fractures in the bones and amputations; Participants who had pregnancy and / or surgery and coma from the past year S24.1, S34 Other and unspecified injuries of thoracic spinal cord, Other and unspecified injury of lumbar and sacral spinal cord Rehabilitation Rehabilitation Intervention group: are individuals with spinal cord injury and their family caregivers. Interventions include the pre-test, multiple educational interventions through two sessions of the classroom, instructional films (physical empowerment in person with SCI), instruction booklet ( include physical, mental and psychological care tips for a person with SCI and their caregivers), education by telegram and follow up by telephone, run post tests one month later and three months later Control group: person with spinal cord injury and their family caregivers that they receive rehabilitation routine programs. Quality of life for spinal cord injury person. Timepoint: At the beginning of the study; one month later; three months later. Method of measurement: Quality of life questionnaire for the person with spinal cord injury (Frans and Powers) and general quality of life questionnaire (Frans and Powers). Health behaviors. Timepoint: At the beginning of the study; one month later; three months later. Method of measurement: Health behavior questionnaire. Quality of life for family caregivers. Timepoint: At the beginning of the study; one month later; three months later. Method of measurement: General quality of life questionnaire (Frans and Powers). Brain and spinal cord injury reseach center Approved 2015-12-26 The Ethics Committee of the Vice-Chancellor of Research Tehran University of Medical Sciences Brain and spinal cord research center, emam khomeini hospital, Keshavarz Blvd, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)