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IRCT2012121511758N1 IRCT 2013-01-05 Vice-Chancellor for Reseach of Tehran University of Medical Science Comparison effectiveness of educaion and telenursing on self-management in adult with Epilepsy Comparison of the effectiveness of educaional intrervention based Adult Learning Theory- with and without telephone follow up by nurse(telenursing) on self-management in adult with Epilepsy 2012-07-29 anticipated 120 Complete https://irct.ir/trial/11910 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive. N/A Condition 1: Localization-related (focal)(partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset. Condition 2: Localization-related (focal)(partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures. Condition 3: Localization-related (focal)(partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures. Condition 4: Generalized idiopathic epilepsy and epileptic syndromes. Condition 5: Other generalized epilepsy and epileptic syndromes. Condition 6: Special epileptic syndromes. Condition 7: Grand mal seizures, unspecified (with or without petit mal). Condition 8: Petit mal, unspecified, without grand mal seizures. Condition 9: Other epilepsy. Condition 10: Epilepsy, unspecified. Intervention 1: Education based on Adult Learning Theory - The education program was developed to be delivered in a group discussion for approximately 10–12 individuals, meeting for a 1-hour once per week for 4 consecutive .The curriculum included a mixture of psychosocial and medical information topics framed in the self-management activities.The overriding theme of self-management was built into all sessions, session materials, and session discussions. For example, meeting 1 focused on information management, Topics that were discussed in detail focused on definition of epilepsy, type of seizure, diagnosis and treatment. Other discussed topic was medication management (such as maintaining blood levels of medications, side effects, drug toxicity identification), seizure triggers and life style management, including sleep, exercise, stress, smoking and other risky behaviors, safety management, psychosocial factors such as depression, stigma, occupation, marriage, social interaction and etc. We also solicited input from the group participants on each topic throughout the discussion and encouraged sharing of personal histories, experiences, perspectives, and approaches to self-management. Group leaders helped to identify the self-management strategies used by participants in real-life scenarios. Intervention 2: Education based on Adult Learning Theory plus Telephone Follow up by Nurse - The education program was developed to be de 1-hourblock of time once per week for 4 consecutive weeks. The curriculum included a mixture of psychosocial and medical information topics framed in the self-management activities.The overriding theme of self-management was built into all sessions, session materials, and session discussions. For example, meeting 1 focused on information management. Topics that were discussed in detail focused on definition of epilepsy, type of seizure, diagnosis and treatment. Other discussed topic was medication management (such as maintaining blood levels of medications, side effects, drug toxicity identification), seizure triggers and life style management, including sleep, exercise, stress, smoking and other risky behaviors, safety management, psychosocial factors such as depression, stigma, occupation, marriage, social interaction and etc. We also solicited input from the group participants on each topic throughout the discussion and encouraged sharing of personal histories, experiences, perspectives, and approaches to self-management. Group leaders helped to identify the self-managementstrategies used by participants in real-life scenarios. This session was followed by six telephone- based on sessions content over the next 2 months (first month weekly and second month every 2 week) aimed at enhancing self-management practices in thefollowing areas: medication, information, seizure, safety, and lifestyle. For each of the phone contact, the nurses first discussed medication management with the participant.The nurse began by asking a general question about medication-taking practices. Participants who were taking medications as prescribed and had no difficulties were encouraged to continue with their regimen. Those who reported problems with medications(e.g., nonadherence or side effects) were provided supportin weighing the costs and benefits of adherence, eliciting barriersto adherence and supporting efforts to solve the barriers to adherence. Following the discussion of medications, the nurse asked the participant to select one or two other self-management components that were important to him or her. The subsequent discussion was directed toward identifying barriers and facilitators of desired behaviors(e.g., reducing stress). Participants were encouraged to develop their own solutions and devise an action plan. Intervention 3: The participants enrolled in the control group received no intervention.
public Elham Bagheri Baghabrishami
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq., Tehran, Iran
Tehran Iran (Islamic Republic of) +98 21 6692 7171 elsa.1384@yahoo.co Tehran university of medical sience scientific Zahra Rahnavard
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq., Tehran, Iran
Tehran Iran (Islamic Republic of) +98 21 6692 7171 zahra.rahnavard@gmail.com Tehran University of Medical Science Iran (Islamic Republic of) Individuals were eligible if they had been diagnosed of epilepsy by a neurologist, diagnosed with epilepsy for at least 6 months; were receiving antiepileptic drugs (AEDs); were 18 years old and elder ; were able to understand and speak Persian ; had a telephone (or access to one).Residents in Isfahan and its surrounding. Exclusion criteria: Unwilling to participate in Clinical Trial Hospitalized for any reason during the training sessions Non participate in any of education session (in education and education plus telephone follow up groups) - No answer to 2 or more phone contacts(in education plus telephone follow up group) 18 years 139 years Both G40.0 G40.1 G40.2 G40.3 G40.4 G40.5 G40.6 G40.7 G40.8 G40.9 Incl.: Benign childhood epilepsy with centrotemporal EEG spikes- Childhood epilepsy with occipital EEG paroxysms Incl.: Attacks without alteration of consciousness- Simple partial seizures developing into secondarily generalized seizures Incl.: Attacks with alteration of consciousness, often with automatisms- Complex partial seizures developing into secondarily generalized seizures Incl.:Benign: myoclonic epilepsy in infancy- neonatal convulsions (familial)- Childhood absence epilepsy [pyknolepsy]- Epilepsy with grand mal seizures on awakening- Juvenile: absence epilepsy- myoclonic epilepsy [impulsive petit mal]- Nonspecific epilept Incl.:Epilepsy with: myoclonic absences- myoclonic-astatic seizures- Infantile spasms- Lennox-Gastaut syndrome-Salaam attacks- Symptomatic early myoclonic encephalopathy- West syndrome Incl.: Epilepsia partialis continua [Kozhevnikof]- Epileptic seizures related to: alcohol, drugs, hormonal changes, sleep deprivation, stress Incl.: Epilepsies and epileptic syndromes undetermined as to whether they are focal or generalized Incl.: Epileptic: convulsions NOS- fits NOS- seizures NOS Other Other Other Education based on Adult Learning Theory - The education program was developed to be delivered in a group discussion for approximately 10–12 individuals, meeting for a 1-hour once per week for 4 consecutive .The curriculum included a mixture of psychosocial and medical information topics framed in the self-management activities.The overriding theme of self-management was built into all sessions, session materials, and session discussions. For example, meeting 1 focused on information management, Topics that were discussed in detail focused on definition of epilepsy, type of seizure, diagnosis and treatment. Other discussed topic was medication management (such as maintaining blood levels of medications, side effects, drug toxicity identification), seizure triggers and life style management, including sleep, exercise, stress, smoking and other risky behaviors, safety management, psychosocial factors such as depression, stigma, occupation, marriage, social interaction and etc. We also solicited input from the group participants on each topic throughout the discussion and encouraged sharing of personal histories, experiences, perspectives, and approaches to self-management. Group leaders helped to identify the self-management strategies used by participants in real-life scenarios. Education based on Adult Learning Theory plus Telephone Follow up by Nurse - The education program was developed to be de 1-hourblock of time once per week for 4 consecutive weeks. The curriculum included a mixture of psychosocial and medical information topics framed in the self-management activities.The overriding theme of self-management was built into all sessions, session materials, and session discussions. For example, meeting 1 focused on information management. Topics that were discussed in detail focused on definition of epilepsy, type of seizure, diagnosis and treatment. Other discussed topic was medication management (such as maintaining blood levels of medications, side effects, drug toxicity identification), seizure triggers and life style management, including sleep, exercise, stress, smoking and other risky behaviors, safety management, psychosocial factors such as depression, stigma, occupation, marriage, social interaction and etc. We also solicited input from the group participants on each topic throughout the discussion and encouraged sharing of personal histories, experiences, perspectives, and approaches to self-management. Group leaders helped to identify the self-managementstrategies used by participants in real-life scenarios. This session was followed by six telephone- based on sessions content over the next 2 months (first month weekly and second month every 2 week) aimed at enhancing self-management practices in thefollowing areas: medication, information, seizure, safety, and lifestyle. For each of the phone contact, the nurses first discussed medication management with the participant.The nurse began by asking a general question about medication-taking practices. Participants who were taking medications as prescribed and had no difficulties were encouraged to continue with their regimen. Those who reported problems with medications(e.g., nonadherence or side effects) were provided supportin weighing the costs and benefits of adherence, eliciting barriersto adherence and supporting efforts to solve the barriers to adherence. Following the discussion of medications, the nurse asked the participant to select one or two other self-management components that were important to him or her. The subsequent discussion was directed toward identifying barriers and facilitators of desired behaviors(e.g., reducing stress). Participants were encouraged to develop their own solutions and devise an action plan. The participants enrolled in the control group received no intervention. Epilepsy self-management. Timepoint: At baseline - 4months after. Method of measurement: Epilepsy Self-Management Scale(ESMS). Age. Timepoint: At baseline. Method of measurement: Demographic information. Gender. Timepoint: At baseline. Method of measurement: Demographic information. Education level. Timepoint: At baseline. Method of measurement: Demographic information. Marital status. Timepoint: At baseline. Method of measurement: Demographic information. Occupation. Timepoint: At baseline. Method of measurement: Demographic information. Economic status. Timepoint: At baseline. Method of measurement: Demographic information. Insurance. Timepoint: At baseline. Method of measurement: Demographic information. Duration of disease. Timepoint: At baseline. Method of measurement: Demographic information. Type of seizure. Timepoint: At baseline. Method of measurement: Demographic information. Number of Antiepileptic Drugs. Timepoint: At baseline. Method of measurement: Demographic information. Frequency of seizure. Timepoint: At baseline. Method of measurement: Demographic information. Other disease. Timepoint: At baseline. Method of measurement: Demographic information. Vice-Chancellor for Reseach of Tehran University of Medical Science Approved 2012-07-29 Tehran University of Medical Science Tehran University of Medical Science, Tehran, Iran Tehran Iran (Islamic Republic of)