]>
IRCT20181226042140N2 IRCT 2020-07-03 National Institute for Medical Research Development Investigating the intervention of mindfulness on on promoting medication adherence among patient with epilepsy The effects of mindfulness-based cognitive therapy on promoting medication adherence among patient with epilepsy: an application of social media intervention 2020-06-20 anticipated 256 Complete https://irct.ir/trial/48820 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Regarding the stratified block ranomization in this study, it is stated that the randomization is performed in 4 neurology clinics. Two groups are selected from each of these centers, one for the intervention group and the other for the control group. Of these 128 are in the intervention group and 128 are in the control group. Randomization is done using software, and after the groups are identified, the code for the intervention group and control group is placed in the envelope and the envelopes are numbered. This is determined by whether the patient is in the intervention group or the control group, after he or she visits the center and receives the envelope and sees the content inside, Blinding description: Randomization will be performed at a center level. Neurology clinics will randomly allocate (1:1) in intervention and treatment as usual groups. Randomization and allocation will be performed by an independent statistician who is blinded to participants’ clinical histories. N/A Epilepsy. Intervention 1: Intervention group: It will be the first trial targeting medication adherence through an online mindfulness intervention.Each week, the intervention group will receive an email from the primary researcher to inform them that a class has uploaded to the social media group to be completed at a time that suited them and would be accessible for one week.It will be 4 sessions of online psychoeducation in the treatment as usual group. At the sessions, the patients will give information about the aetiology, symptoms, and prognosis of epilepsy, as well as antiepileptic drug, and their possible side effects. Each patient member is also provided with information about the importance of medication adherence and the risks of discontinuing the medication. An online booklet providing information about epilepsy and possible drug treatments will be provided for the patients.Patients with epilepsy will randomly assig into two groups 1) intervention and 2) treatment as usual. All participants will complete measurements at baseline (before randomization) and post intervention and six months after completing the intervention. Intervention 2: Control group: They receive their medications as usual. 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 further information.
public Amir Pakpour
Social Determenant of Health Research Center.,Shahid Bahonar Blvd.,Qazvin University of Medical Sciences
Qazvin Iran (Islamic Republic of) 3419915315 +98 28 3334 4589 apakpour@qums.ac.ir Qazvin University of Medical Sciences scientific Amir pakpour
Social Determenant of Health Research Center.,Shahid Bahonar Blvd.,Qazvin University of Medical Sciences
Qazvin Iran (Islamic Republic of) 3419915315 +98 28 3334 4589 apakpour@qums.ac.ir Qazvin University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) A confirmed diagnosis of epilepsy in patients by a physician specializing in neurology An age of 18 years or older Prescribing antiepileptic drugs Being responsible for taking the medicine by oneself or an independent person 18 years no limit Both Suffering from progressive neurological disease Do not prescribed antiepileptic drugs Diagnosis of an intellectual disability Having a major cognitive impairment G40.1 Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures Behavior N/A Intervention group: It will be the first trial targeting medication adherence through an online mindfulness intervention.Each week, the intervention group will receive an email from the primary researcher to inform them that a class has uploaded to the social media group to be completed at a time that suited them and would be accessible for one week.It will be 4 sessions of online psychoeducation in the treatment as usual group. At the sessions, the patients will give information about the aetiology, symptoms, and prognosis of epilepsy, as well as antiepileptic drug, and their possible side effects. Each patient member is also provided with information about the importance of medication adherence and the risks of discontinuing the medication. An online booklet providing information about epilepsy and possible drug treatments will be provided for the patients.Patients with epilepsy will randomly assig into two groups 1) intervention and 2) treatment as usual. All participants will complete measurements at baseline (before randomization) and post intervention and six months after completing the intervention. Control group: They receive their medications as usual. The medication adherence score. Timepoint: Immediately after the intervention and 6 months after the intervention. Method of measurement: The Medication Adherence Report Scale(MARS). Mindful Attention Awareness score. Timepoint: Immediately after the intervention and 6 months after the intervention. Method of measurement: Mindful Attention Awareness Scale(MAAS). Severity of a patient's seizures score. Timepoint: Immediately after the intervention and 6 months after the intervention. Method of measurement: Liverpool Seizure Severity Scale(LSSS). Quality of life in epilepsy score. Timepoint: Immediately after the intervention and 6 months after the intervention. Method of measurement: Health-related quality of life. Perceived behavioral control questions. Timepoint: Immediately after the intervention and 6 months after the intervention. Method of measurement: Perceived behavioral control(PBC). Anxiety and depression score. Timepoint: Immediately after the intervention and 6 months after the intervention. Method of measurement: Hospital Anxiety and Depression Scale (HADS). Patient's beliefs about medication. Timepoint: Immediately after the intervention and 6 months after the intervention. Method of measurement: Beliefs about Medications Questionnaire (BMQ). Intention to adhere to medication. Timepoint: Immediately after the intervention and 6 months after the intervention. Method of measurement: Behavioral intention Questions. Self-monitoring by the patient in taking his medications. Timepoint: Immediately after the intervention and 6 months after the intervention. Method of measurement: Self-monitoring questions. Plan for time, place, how to take medicine. Timepoint: Immediately after the intervention and 6 months after the intervention. Method of measurement: Questions about Action planning. Predicting drug use barriers and creating strategies to overcome those barriers. Timepoint: Immediately after the intervention and 6 months after the intervention. Method of measurement: Questions about Coping planning. Investigation of automatic drug use by patients with epilepsy. Timepoint: Immediately after the intervention and 6 months after the intervention. Method of measurement: Self-Report Behavioural Automaticity Index (SRBAI). National Institute for Medical Research Development Approved 2019-12-06 Ethics Committee in Research of the National Institute for Medical Research Development in Sciences No.21, Besat Ave., Western Fatemi Ave. Tehran Tehran Iran (Islamic Republic of)