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IRCT20220907055909N1 IRCT 2022-10-03 Esfahan University of Medical Sciences Investigating the effect of family-centered intervention on adherence to diabetes treatment Design, implementation and evaluation of family-centered intervention program on adherence to treatment in Type 2 Diabetic patients 2026-02-27 anticipated 110 Recruiting https://irct.ir/trial/65870 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: The studied patients will be examined and compared in 2 groups. A control group is diabetic patients who receive routine care. The family members are present with the patient and in this group the patient and the family member are considered as an intervention unit, the training is provided to the patient himself and the families do not participate in educating and informing the patient and play a passive role or They have a patio. In the intervention group, the family member will participate directly in the clinical care processes. Family members are considered as independent units and direct contributors. In this group, the intervention is done on the family members and the family member plays the main role. In this group, the application is installed on the family member's mobile phone or tablet, the family member is taught how to perform the intervention and how to use it (receiving training and compliance programs for family-oriented treatment through the application) and answers to the existing problems. It will be given. In this group, patients will receive the usual care and family members (not patients) as patient supporters, will receive the necessary training in the field of diabetes control through the installation of the designed application. All educational programs using the application with Various methods such as text, images, videos, listening profile and multimedia are presented to the intervention group and the convenience of family members to receive information is also considered and patients and their family members are advised to Ask any questions or problems regarding how to use the application. In addition to that, training on how to use the application is sent in the form of video and text in the application, and one day after receiving the application, the training will be sent weekly in the application. Submissions will be based on the constructs of awareness, perceived threat, perceived benefits, perceived barriers, perceived self-efficacy, outcome expectations (positive outcomes), self-regulation, and perceived social support. For example, for the perceived threat regarding the complications caused by diabetes, an educational video on foot injury and diabetic foot ulcer will be shown, and the statistics related to leg amputation due to diabetes and lack of blood sugar control will be displayed as a message. Or for self-efficacy in the field of how to perform a daily foot examination by the person himself, it is taught step by step through the video so that the person is able to perform the foot examination alone. Data collection will be done at the beginning of the study and 3 months after the intervention, Randomization description: In this study, research samples are first selected based on the available criteria and then randomly (Block Randomization) are divided into intervention and control groups. In this method, block randomization is used; Blocking is used in order to balance the number of samples allocated to each of the studied groups, so that since we have two groups under study, we use equal blocks of 4 and create all possible states of 4. Then, the sequence of the blocks is determined with the simple randomization service software, and since the sample size in this study is 110 people (55 people in each group), 28 blocks of 4 are used. Blocked randomization method Balanced and using Sealed Envelope Ltd web software. It is 2020. The method of random allocation is using blocks of size 4. Randomization will be performed by a statistician, who will have no contact with the patients. Researchers and study participants are unaware of the randomization sequence. After confirming the patient's entry into the study, the clinical researcher places the patient in the intervention groups by registering the patient's code based on the determined random sequence, Blinding description: Randomization will be performed by a statistician, who will have no contact with the patients. Researchers and study participants are unaware of the randomization sequence. After confirming the patient's entry into the study, the clinical researcher places the patient in the intervention groups by registering the patient's code based on the determined random sequence. N/A Type 2 diabetes. Intervention 1: Intervention group: This group will receive the intervention under the application on the mobile phone for 8 weeks, and all educational programs will be presented to the intervention group using the application in various ways, including text, images, videos, audio profiles, and multimedia. Intervention 2: Control group: This group will receive the usual programs at the diabetes center. 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 Seyedeh Azemat Mousavifar
Department of Health Education and Health Promotion, School of Health, Isfahan University of Medical Sciences, Hezar Jerib St., Isfahan
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 8628 mousavifar.a@mui.ac.ir Esfahan University of Medical Sciences scientific Seyedeh Azemat Mousavifar
Department of Health Education and Health Promotion, School of Health, Isfahan University of Medical Sciences, Hezar Jerib St., Isfahan
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 8628 mousavifar.a@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Have type 2 diabetes and their diabetes has been diagnosed and confirmed by a doctor before registration Have diabetes for at least 6 months HbA1c level equal to or greater than 7 Be in the age range of 18 to 60 years old Be literate in reading and writing Have a phone at home Have a mobile phone personally or in the family in order to participate in the program Do not have disabling physical problems and diseases Are not pregnant and do not intend to become pregnant during the study period Do not suffer from known psychological diseases Do not suffer from serious diseases (such as liver failure, kidney failure, etc.) Willing to participate in the study and complete the informed consent form Do not currently participate in other research studies. Family member entry criteria: Be over 18 years old Do not have diabetes Be a First degree family member (wife, child, parent, sister or brother) Be literate in reading and writing Willing to participate in the study Can use a smartphone 18 years 60 years Both Being hospitalized during the study for any reason Suffering from diabetic ketoacidosis or hyperglycemic hyperosmolar Nonketotic syndrome Suffering from serious diseases such as advanced form of cardiovascular diseases, uncontrolled high blood pressure, psychological disorders, severe vision disorders, psychiatry diseases or suffering from physical or mental problems preventing participation in the research Unwillingness of the patient or family member to participate or continue cooperation E11.9 Type 2 diabetes mellitus without complications Behavior N/A Intervention group: This group will receive the intervention under the application on the mobile phone for 8 weeks, and all educational programs will be presented to the intervention group using the application in various ways, including text, images, videos, audio profiles, and multimedia. Control group: This group will receive the usual programs at the diabetes center. Medication compliance score. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Morisky Medication Adherence Scale. Physical activity score. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: International Physical Activity Questionnaire (IPAQ ). Self-Efficacy Scale. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Diabetes Management Self-Efficacy Scale(DMSES). Self-care behaviors score. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Summary of Diabetes Self Care Activities (SDSCA). Perceived family social support score. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Diabetes Specific Family Support Scale. Self-regulation score in treatment. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Treatment Self-Regulation Questionnaire (TSRQ). Glycosylated hemoglobin. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Blood sample test. Esfahan University of Medical Sciences Approved 2022-08-22 Ethics Committees of Medical University of Isfahan Department of Health Education and Health Promotion, School of Health, Isfahan University of Medical Sciences, Hezar Jerib Street. Isfahan Isfehan Iran (Islamic Republic of)