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IRCT20131112015390N4 IRCT 2020-08-21 Oroumia University of Medical Sciences The effect of family-centered education on treatment adherence and glycosylated hemoglobin Effect of family Centered_Education on Treatment Adherence and Glycosylated Hemoglobin in Patients with Type 1 Diabetes 2020-01-21 anticipated 60 Complete https://irct.ir/trial/48639 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Randomization description: The participants were randomly divided into two intervention (n=30) and control (n=30) groups through simple random allocation. Randomization was performed according to the numbers randomly selected by Random Allocation Software ( Version 1.0.0) in the computer, and participants were divided into intervention or control groups based on pre-designated numbers. N/A Type 1 Diabetes. Intervention 1: The patients in the intervention group will be asked to introduce an immediate family member (spouse, parents, child, or sibling) with whom they have the most interaction. Then their educational needs will be assessed and determined using a checklist prepared in advance. The needs assessment will be performed to design and implement the best intervention method and ensure the intervention's effectiveness in achieving the study's objectives. After the needs assessment, the educational program's content will be prepared using a literature review and valid books and articles according to the educational needs of patients and family members and the approval of an endocrinologist. The educational sessions will be held based on need assessment checklists and the needs of patients and their active family members in each group. The intervention group (with active family members) will be divided into three small sub-groups with ten patients each. Four educational sessions will be held for each sub-group. Then, 12 training sessions will be held to empower patients and their active family members in the intervention group. Thus, one session per week will be held for groups one, two, and three on Saturdays, Mondays, and Wednesdays, respectively. Training sessions will be ended in four weeks. The first session topics will be included endocrine physiology, diabetes, types of diabetes, and its symptoms and treatment. In the second session, the importance of adherence to treatment, the reasons for not accepting treatment, and the symptoms and complications of the lack of adherence to treatment procedure will be discussed. The third session will be about diabetes care such as diet, tips to take medications, preventing complications, blood sugar self-monitoring, and foot care. In the fourth session, "Question and Answer Session," the questions and concerns of patients and their active family members will be addressed. The content of each session will be given to the patients' family members to review with their patients and write down what they will learn or the questions they might have to discuss them at the beginning of the following session. It is noteworthy that the two researchers will be presented in all 12 sessions of group discussions and will make the discussion more effective with their guidance when appropriate. After the intervention is over, the patients and family members will be given three months to take care of themselves and keep their illness under control based on the skills they will gain during educational sessions. The pre-designed care checklist will be given to the active members of the patients to fill in based on the care provided for patients and to give it to the researcher at a certain time at the beginning of each week in Urmia Diabetes Association. After four months of the family-centered empowerment education course, all patients will be called to refer to the Urmia Diabetes Association. After taking blood samples from all patients, Modanloo adherence to the treatment questionnaire will be completed again by patients in both groups. Educational packages, including booklets, DVDs, and pamphlets, will also be provided to patients in the control group at the end of the study. Intervention 2: Control group: They will receive routine education from the Urmia Diabetes Association.Three educational sessions (one and a half hours each) per week are the routine education in the Urmia Diabetes Association. Classes on diabetes, symptoms, and treatment by an endocrinologist on Saturday, nutrition education on diabetes by a nutritionist on Monday, and anxiety reduction classes by a psychiatrist on Wednesday. Yes - There is a plan to make this available What will be shared: Laboratory data on fasting blood sugar and glycosylated hemoglobin and treatment adherence scores When: ۲۰۲۰/۰۷/۲۰ To whom: University of Medical Sciences Professors Conditions: Statistical analysis Where to obtain: parizad.n@umsu.ac.ir How to obtain: by Email Comments:
public Mahsa Mansour
Unit 44, 4th floor,Shahid Danaeifar block,The third town of Khordad, West Yasemi Street,North Kurdistan Street
Tehran Iran (Islamic Republic of) 1996813461 +98 21 8862 5107 parizad.n@umsu.ac.ir Oroumia University of Medical Sciences scientific Mahsa Mansour
Unit 44, 4th floor,Shahid Danaeifar block,The third town of Khordad, West Yasemi Street,North Kurdistan Street
Tehran Iran (Islamic Republic of) 1996813461 +98 21 8862 5107 parizad.n@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) Diagnosis of type 1 diabetes for at least one year by a specialist Lack of mental illness with the approval of a specialist Age between 15-30 years Willingness to participate in the study Not having early or late side effects Living with family Not having a private nurse 15 years 30 years Both Unwillingness to participate to the study Having an active family member as a medical staff Having a physical disability Inability to read and write of a patient or active family member E10 Type 1 diabetes mellitus Other Other The patients in the intervention group will be asked to introduce an immediate family member (spouse, parents, child, or sibling) with whom they have the most interaction. Then their educational needs will be assessed and determined using a checklist prepared in advance. The needs assessment will be performed to design and implement the best intervention method and ensure the intervention's effectiveness in achieving the study's objectives. After the needs assessment, the educational program's content will be prepared using a literature review and valid books and articles according to the educational needs of patients and family members and the approval of an endocrinologist. The educational sessions will be held based on need assessment checklists and the needs of patients and their active family members in each group. The intervention group (with active family members) will be divided into three small sub-groups with ten patients each. Four educational sessions will be held for each sub-group. Then, 12 training sessions will be held to empower patients and their active family members in the intervention group. Thus, one session per week will be held for groups one, two, and three on Saturdays, Mondays, and Wednesdays, respectively. Training sessions will be ended in four weeks. The first session topics will be included endocrine physiology, diabetes, types of diabetes, and its symptoms and treatment. In the second session, the importance of adherence to treatment, the reasons for not accepting treatment, and the symptoms and complications of the lack of adherence to treatment procedure will be discussed. The third session will be about diabetes care such as diet, tips to take medications, preventing complications, blood sugar self-monitoring, and foot care. In the fourth session, "Question and Answer Session," the questions and concerns of patients and their active family members will be addressed. The content of each session will be given to the patients' family members to review with their patients and write down what they will learn or the questions they might have to discuss them at the beginning of the following session. It is noteworthy that the two researchers will be presented in all 12 sessions of group discussions and will make the discussion more effective with their guidance when appropriate. After the intervention is over, the patients and family members will be given three months to take care of themselves and keep their illness under control based on the skills they will gain during educational sessions. The pre-designed care checklist will be given to the active members of the patients to fill in based on the care provided for patients and to give it to the researcher at a certain time at the beginning of each week in Urmia Diabetes Association. After four months of the family-centered empowerment education course, all patients will be called to refer to the Urmia Diabetes Association. After taking blood samples from all patients, Modanloo adherence to the treatment questionnaire will be completed again by patients in both groups. Educational packages, including booklets, DVDs, and pamphlets, will also be provided to patients in the control group at the end of the study. Control group: They will receive routine education from the Urmia Diabetes Association.Three educational sessions (one and a half hours each) per week are the routine education in the Urmia Diabetes Association. Classes on diabetes, symptoms, and treatment by an endocrinologist on Saturday, nutrition education on diabetes by a nutritionist on Monday, and anxiety reduction classes by a psychiatrist on Wednesday. Mean scores of adherence to treatment. Timepoint: Before intervention and 4 months after intervention. Method of measurement: Modanloo Adherence to Treatment Questionnaire (MATQ). Fasting blood sugar. Timepoint: Before intervention and four months of intervention. Method of measurement: Laboratory blood samples. Glycosylated hemoglobin. Timepoint: Before intervention and four months after intervention. Method of measurement: Laboratory blood samples. Mahsa Mansour Approved 2020-01-18 Ethics Committee of Urmia University of Medical Sciences Urmia University of Medical Sciences Headquarters, Emergency Alley, Resalat Street Urmia West Azarbaijan Iran (Islamic Republic of)