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IRCT20180728040617N4 IRCT 2022-12-12 Shahroud University of Medical Sciences The effect of online group support on psychological distress and self-care behaviors of the elderly with type 2 diabetes during the COVID-19 pandemic: a parallel randomized clinical trial The effect of online group support on psychological distress and self-care behaviors of the elderly with type 2 diabetes during the COVID-19 pandemic: a parallel randomized clinical trial 2022-12-22 anticipated 90 Complete https://irct.ir/trial/66995 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients will be divided into intervention and control groups by random block allocation using quadruple blocks created by SPSS software version 22. According to the sample size of 90 in the present study, 23 quadruple blocks will be considered. Each patient will be randomly assigned to Group A (intervention) or B (control group) in the order determined by the software, and the sampling process will be performed sequentially until sampling is completed. Individuals are assigned to the target group in order of their entry into the study and randomly through randomized blocks. N/A Diabetes. Intervention 1: Intervention group: For the intervention group, 6 sessions will be held in 3 weeks for a duration of 60 minutes in the form of participation in a group video call (webinar) in the form of lectures, group discussions, questions and answers, slide shows and clips. Supportive content in the educational field: (diabetes education, diet, physical activity and medication in diabetes) and in the psychological field of the stress management program according to the theoretical model of stress management by Lazarus and Folkman (1- stress education and factors affecting it 2- support older adults in identifying ineffective and stressful thoughts 3- Providing solutions (problem-oriented and emotion-oriented) in dealing with stress 4- Providing support in applying the support provided in daily life. Data collection tools include demographic information form, Lavibond anxiety and depression scale (DASS-21) and Tobert and Glasgow diabetes self-care which were administered by all patients before the intervention before the first session. (Intervention and Control Group), will be completed online. After 7 days from the end of the intervention sessions, the mentioned questionnaires will be completed to assess the effect of the intervention. Intervention 2: Control group: They will receive routine support from the treatment centre. Supporting contents will be provided to the control group after the intervention. Yes - There is a plan to make this available What will be shared: Some of the patient's demographic information can be shared after unidentifying individuals. All of the patients' psychological distress and self care behaviors assessment information can be shared with caregivers after unidentified individuals. When: After publishing the article To whom: Project partners Conditions: People who do similar research Where to obtain: It will be done by email with the person in charge of the project. How to obtain: Data is made available to individuals via email. Comments:
public Fateme Ebrahimiyan
Bahar Hospital, 22th Bahman St., Shahroud, Iran.
Shahroud Iran (Islamic Republic of) 3614773947 +98 23 3239 5054 ebrahimiyan.fateme@yahoo.com Shahroud University of Medical Sciences scientific Hossein Ebrahimi
Shahroud University of Medical Sciences, Tehran St., Shahroud, Iran.
Shahroud Iran (Islamic Republic of) 3614773955 +98 23 3239 3811 ebrahimi@shmu.ac.ir Shahroud University of Medical Sciences Iran (Islamic Republic of) Age at least 15 years The definitive diagnosis of diabetes has been made by a doctor Smartphone access Having minimum media literacy Ability to access the Internet and online mass communication software. No psychological disorders Non-participation in other supportive interventions. 60 years no limit Both Do not participate in the post-test Absence from more than two sessions in support sessions Patient death during the study Occurrence of stressful events (except for the usual treatment process) for the patient E08 Diabetes mellitus due to underlying condition Other N/A Intervention group: For the intervention group, 6 sessions will be held in 3 weeks for a duration of 60 minutes in the form of participation in a group video call (webinar) in the form of lectures, group discussions, questions and answers, slide shows and clips. Supportive content in the educational field: (diabetes education, diet, physical activity and medication in diabetes) and in the psychological field of the stress management program according to the theoretical model of stress management by Lazarus and Folkman (1- stress education and factors affecting it 2- support older adults in identifying ineffective and stressful thoughts 3- Providing solutions (problem-oriented and emotion-oriented) in dealing with stress 4- Providing support in applying the support provided in daily life. Data collection tools include demographic information form, Lavibond anxiety and depression scale (DASS-21) and Tobert and Glasgow diabetes self-care which were administered by all patients before the intervention before the first session. (Intervention and Control Group), will be completed online. After 7 days from the end of the intervention sessions, the mentioned questionnaires will be completed to assess the effect of the intervention. Control group: They will receive routine support from the treatment centre. Supporting contents will be provided to the control group after the intervention. Psychological distress. Timepoint: At the beginning of the study (before the intervention) and 7 days after intervention. Method of measurement: Lovibond Depression, Anxiety and Stress Scale (DASS-21). Self care behaviors. Timepoint: At the beginning of the study (before the intervention) and 7 days after intervention. Method of measurement: Toobert & Glasgow diabetes self care scale. Shahroud University of Medical Sciences Approved 2022-11-02 Ethics Committee of Shahroud University of Medical Sciences Shahroud University of Medical Sciences, Tehran St., Shahroud, Iran. Shahroud Semnan Iran (Islamic Republic of)