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IRCT20210601051465N1 IRCT 2021-06-27 Tehran University of Medical Sciences Evaluating of an educational intervention on Treatment adherence among patients with Type2 diabetes Evaluating of an educational-supportive virtual intervention on treatment adherence among patients with Type 2 diabetes with limited health literacy 2021-06-22 anticipated 264 Complete https://irct.ir/trial/56630 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization will be conducted using random permuted blocks method by R software R(https://www.r-project.org/). It will make six possible sequences; these are AABB, ABAB, ABBA, BAAB, BABA, BBAA. The different diabetic centers will be alphabetically coded (e.g. A, B, C, D and so on) and a participant will attach to each diabetic center will be given numerical codes (e.g. participants in diabetic center Y were numbered A001, A002, A003 and so on).It is noted that patients with type 2 diabetes has medical records in each diabetes center. N/A Condition 1: Type 2 diabetes. Condition 2: Health literacy. Condition 3: Treatment adherence. Intervention 1: Intervention group: Participants will be invited to complete the questionnaires at the baseline, three and six months after the end of intervention. Both intervention and control groups will be attended the regular diabetes education in the diabetes center. In addition, the intervention group will be received virtual educational program based on Empowerment Model constructs in eight episodes lasting 45–60 minutes in every week for two months. The constructs include perceived threats, participation, evaluation and follow up. These constructs will be considered regarding improvement of adherence to treatment among patients with type 2 diabetes. Moreover, text messages will be sent as a boosting after intervention that serves as a quick reference to the education. The content of educational programs will be included information about treatment adherence based on proper health literacy strategies and diabetes complications about not adherence to treatment. The trainers will be followed an approved lesson plan to provide educational information regarding adherence to treatment. The trainers will be skilled health providers who have at least bachelor degree. The theoretical framework of the study will be based on Empowerment Model to provide an opportunity to improve health literacy to achieve better treatment adherence for participants. Intervention 2: Control group: This group will be received only the routine diabetes education in centers. There will be no more intervention for control group. 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 It is not yet known if there will be a plan to make this available
public Roya Sadeghi
Keshavarz Blvd, Poursina St., School of Public Health, Tehran University of Medical Sciences
Tehran Iran (Islamic Republic of) 141556446 +98 21 4293 3055 sadeghir@tums.ac.ir Tehran University of Medical Sciences scientific Roya Sadeghi
Keshavarz Blvd, Poursina St., School of Public Health, Tehran University of Medical Sciences
Tehran Iran (Islamic Republic of) 1417613151 +98 21 4293 3055 sadeghir@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Age over 30 yrs. Limited health literacy Low treatment adherence Type 2 diagnosis confirmed at least 6 months before Willingness to participate in the study 30 years no limit Both Pregnant women with gestational diabetes Type 1 diabetes Comorbidities not related to type 2 diabetes (such as types of cancers and autoimmune system diseases, etc.) Approved psychological problems E11 Z41 Z71 Type 2 diabetes mellitus Encounter for procedures for purposes other than remedying health state Persons encountering health services for other counseling and medical advice, not elsewhere classified Prevention Prevention Intervention group: Participants will be invited to complete the questionnaires at the baseline, three and six months after the end of intervention. Both intervention and control groups will be attended the regular diabetes education in the diabetes center. In addition, the intervention group will be received virtual educational program based on Empowerment Model constructs in eight episodes lasting 45–60 minutes in every week for two months. The constructs include perceived threats, participation, evaluation and follow up. These constructs will be considered regarding improvement of adherence to treatment among patients with type 2 diabetes. Moreover, text messages will be sent as a boosting after intervention that serves as a quick reference to the education. The content of educational programs will be included information about treatment adherence based on proper health literacy strategies and diabetes complications about not adherence to treatment. The trainers will be followed an approved lesson plan to provide educational information regarding adherence to treatment. The trainers will be skilled health providers who have at least bachelor degree. The theoretical framework of the study will be based on Empowerment Model to provide an opportunity to improve health literacy to achieve better treatment adherence for participants. Control group: This group will be received only the routine diabetes education in centers. There will be no more intervention for control group. Health literacy. Timepoint: Before and three months after intervention. Method of measurement: Health literacy questionnaire. Adherence to treatment. Timepoint: Before and six months after intervention. Method of measurement: Modanloo Questionnaire. HbA1c. Timepoint: Before, three and six months after intervention. Method of measurement: Patient medical records (Blood test). Tehran University of Medical Sciences Approved 2021-01-16 Ethics Committee, School of Public Health, Tehran University of Medical Sciences Keshavarz Blvd, Poursina St., School of Public Health, Tehran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)