IRCT2016062528627N1 IRCT 2016-09-24 Vice chancellor for research, Medical University of Ilam, Iran Diabetes Self-Management Education Effectiveness of a nurse-led diabetes self-management education on glycosylated hemoglobin in Iranian Kurdish adults with type 2 diabetes 2016-11-01 anticipated 142 Complete https://irct.ir/trial/23182 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive. 2-3 Type 2 diabetes. Intervention 1: Intervention Group: Receiving the diabetes self-management booklet: The content of “diabetes self-care booklet” provided by Paul Tracy “learning about diabetes” (Tracy, 2015) and American Diabetes Association Website (ADA) (American Diabetes Association, 2015c). The booklet provides general information about how to perform daily self-management activities including diet control, physical activity, blood glucose monitoring, adherence to medication regimen, foot care and healthy living with diabetes. Booklet is easy to read and understand with illustrations and photographs related to self-management of diabetes. The booklet will be given out in the first week of intervention. The content of the booklet will be used in the full-length of entire intervention to further their learning, discussion or to create resources for use. Intervention 2: Intervention Group: Viewing four 10-min movie episodes: During the first 4 weeks of the intervention, participants will be invited to watch four 10-min movie weekly episodes with instructions to remember it. The content of the movie is based on the diabetes self-care booklet. The movie is designed to provide participants with verbal persuasion by describing what T2DM is, short term and long term complications, how to prevent or delay complications and the key steps to diabetes management (session 1), introduction to physical activity and foot care (session2), introduction to healthy eating (session 3), and how to healthy living with diabetes (session 4). The entire movie was created with Powtoon animated video. The movie content is inspired by “animated diabetes patient” website available at: (http://www.animateddiabetespatient.com/en/clist.aspx?c=patient%20video). A copy of the movie will be given to the participants at the end of forth group session. Intervention 3: Intervention Group: Participating in four weekly group sessions: Four group sessions at weekly interval will be undertaken. The goal of group session is to help patients acquire the information, knowledge, self-management practices, goal setting, action plan, problem solving and coping skills required for the effective self-management of their diabetes. All group sessions will be held at times convenient to the participants and the seating will be limited to 10 participants. Each group session will be lasted 120 minutes (2 hours) and contain fostering self-efficacy enhancing skills, self-goal setting, action plan, problem solving, sharing and peer support for diabetes and will be facilitated by the researcher. The discussion will begin with introduction and explanation of the purpose of the meeting. Verbal informed consent will be obtained. Confidentially will be assured and all participants have same opportunity to share and discuss their opinions. A prepared moderator's guide will be applied to provide a semi-structured technique. The focus of the discussion will be (1) to introduce team members to each other (2) to uncover the participants’ awareness and current level of knowledge about diabetes and importance of managing it (3) to set a SMART goals (S-specific (target a specific area for improvement), M- measurable (quantify or at least suggest an indicator of progress), A- assignable (specify who will do it), R-realistic (state what results can realistically be achieved, given available resources), T- time related (specify when the result(s) can be achieved), (4) to produce action plans (5) empowerment and problem-solving skills (6) invite recommendations for future programs including a discussion of motivations and barriers related to diabetes management. Open ended questions will be used to stimulate independent exploration and development of comments and ideas. Moreover, the material in the “Diabetes Self-management” booklets will be used in each session. Participants will be strongly encouraged to attend these sessions accompanied by one family member that will provide a beneficial family support for patient. Intervention 4: Intervention Group: Participating in Telephone Follow-up: During the two months following the end of the focus group sessions, the researcher provided one call per week to participants in the experimental group. The length of each call varies depending on the participant. All telephone calls will be arranged at participants` convenience times. The purpose of calling is to foster continued performance accomplishment via verbal persuasion. In addition, Telephone follow-up will provide continuous enhancing skills fostering, goal-setting sharing and mental support for diabetics through the use of motivational interviewing (MI). Motivational interviewing will be use as tool for behaviour change. The MI counselling approach is patient oriented and it can be used to enhance patient adherence to diet, physical activity, and smoking counselling in daily routine (Miller & Rollnick, 2003). The initial step in MI is to set a specific agenda for consultation together with the participant (Miller & Rollnick, 2003). “Agenda setting” will be an issue to remember right from the beginning of the interview. The key question will be “what are we going to talk about?” Participants will be encouraged to choose one key item in the agenda setting. This make the telephone follow up more structured and will cause a more precise action plan. Then, the researcher will evaluate the patient current behavior and desire for change by rating and exploring confidence and importance regarding the selected key item. This will be done by asking open ended questions, affirmations, reflective listening, summaries, express empathy, develop discrepancy, role with resistance, support self-efficacy, and reinforcing positive change-talk and new behavior. If there is a need and adequate desire for change with the respect to the key item, the researcher will consult with the patient to choose an item as the goal for behavior change (Jansink et al., 2009). Intervention 5: Control Group: Usual diabetes care will be provided for all patients regardless of group allocation. The usual diabetes care practice is based on the Iranian Ministry of Health Guideline on the management of the T2DM, that involve education on self-care management, lifestyle modification (including diet, physical activity, monitoring, feet care) and medications. This education will be provided on an individual basis at three-monthly interval with the duration of 20 -30 minutes per appointment. Face to face lecturing method and pamphlets are used in content delivery. The content consisted of a small amount of information and is mostly confined to the five pillar of diabetes management, i.e.: diet, physical activity, medication, blood glucose monitoring and foot care. Clinical examination and laboratory tests are generally conducted during each visit in accordance with national diabetes guidelines. Based on the result of laboratory tests and examination, individual counseling, recommendation, and renewal of prescribed medication is given at these checkups. Usual diabetes care involves a multidisciplinary team care approach with the patient at the center of the team. Healthcare team includes an internist, a diabetes nurse educator, a nutritionist, a pharmacist and if necessary shared care with an ophthalmologist and endocrinologist.