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IRCT201501128175N3 IRCT 2015-09-18 Endocrinology & Metabolism Research Institute of Tehran University of Medical Sciences Effect of Diabetes Education by Peer Coaching on Diabetes Control and Management Effect of Diabetes Education by Peer Coaching on Diabetes Control and Management 2015-04-09 anticipated 492 Complete https://irct.ir/trial/8620 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive. N/A type 2 Diabetes. Intervention 1: An unblinded randomized clinical trial in which women with type 2 diabetes are divided into one of the two following categories: • intervention group: diabetic patients who received education through peer coaches. Research population is all women with type 2 diabetes who refer to the municipality clinics in Tehran and (Two clinics depend on endocrinology and metabolism research center and health centers in 22 districts of Tehran) for receiving primary care of diabetes (management and education). Intervention: all patients according to the type of receiving drugs contacting with a peer for 6 months. Essential information will be obtained at the beginning of the project (pre-intervention) and 3, 6 and 12 months after intervention. Intervention will be continued for 6-month. All patients in the intervention group, should have two telephone talks with peers, two times face to face meetings and receive three SMS (during one month). If essential they also receive two face-to-face. If necessary, they will have a clinic visit. Meetings, phone talk or SMS, will be made based on the patient and peer agreement. All peers should be record every meeting or call history including contact time, contact type, contact duration, and the subject of talk. Patients will be joint to the peers, according to the gender. The first meeting takes place by telephone and introduction session between the peer and patient will be held. Then specific clinical goals, including HbA1c, FBS, lipid profile (LDL, HDL, TG, Cholesterol) and high blood pressure, self-care skills such as using a glucometer and proper strategies during hypoglycemia, taking drugs, changing lifestyle, healthy eating, physical activity and stress will be discussed. Peers and patients may have talked about family, job or hobbies on holidays. There is not any educational intervention between patient and peer at 6 month to 12 month of the intervention. They just continue their relationship by telephone talking. at least all information will be recorded and measured at 12 month. Intervention 2: An unblinded randomized clinical trial in which women with type 2 diabetes are divided into one of the two following categories: • control group: diabetic patients who received routine care includes attending small group class on diabetes diabetes class or education through national media).
public Mahnaz Sanjari
Shariati Hospital, North Karegar St.
Tehran Iran (Islamic Republic of) 1411413137 +98 21 8822 0088 emri-research@tums.ac.ir Endocrinology and Metabolism Research Institute Tehran University of medical Sciences,Tehran, Iran scientific Dr Neda Mehrdad
Shariati Hospital, North Karegar St.
Tehran Iran (Islamic Republic of) +98 21 8822 0088 emri-research@tums.ac.ir Endocrinology & Metabolism Research Institute of Tehran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria Individuals eligible for attending in the study are women with type 2 diabetes who have HbA1c ≤ 8% in the last 6 months. Patients should not plan to migrate out of Tehran during the period of study and research team could easily have been in contact with them. Additionally, following criteria is essential: • Ability to speak in Persian • Age between 20 and 60 years old • To have HbA1c ≤ 8% in the last 6 months • Not be pregnant • Patients with a life expectancy of less than a year and has a serious illness and disease with reduced cognitive capacity approved by the health center staff will be recruited. • Patients who are currently enrolled in a diabetes education programs are not included in the study. exclusion criteria • To have HbA1c equal and above 9% during the study • Become pregnant during the study 73 years 33 years Female E11 Non-insulin-dependent diabetes mellitus Lifestyle Lifestyle An unblinded randomized clinical trial in which women with type 2 diabetes are divided into one of the two following categories: • intervention group: diabetic patients who received education through peer coaches. Research population is all women with type 2 diabetes who refer to the municipality clinics in Tehran and (Two clinics depend on endocrinology and metabolism research center and health centers in 22 districts of Tehran) for receiving primary care of diabetes (management and education). Intervention: all patients according to the type of receiving drugs contacting with a peer for 6 months. Essential information will be obtained at the beginning of the project (pre-intervention) and 3, 6 and 12 months after intervention. Intervention will be continued for 6-month. All patients in the intervention group, should have two telephone talks with peers, two times face to face meetings and receive three SMS (during one month). If essential they also receive two face-to-face. If necessary, they will have a clinic visit. Meetings, phone talk or SMS, will be made based on the patient and peer agreement. All peers should be record every meeting or call history including contact time, contact type, contact duration, and the subject of talk. Patients will be joint to the peers, according to the gender. The first meeting takes place by telephone and introduction session between the peer and patient will be held. Then specific clinical goals, including HbA1c, FBS, lipid profile (LDL, HDL, TG, Cholesterol) and high blood pressure, self-care skills such as using a glucometer and proper strategies during hypoglycemia, taking drugs, changing lifestyle, healthy eating, physical activity and stress will be discussed. Peers and patients may have talked about family, job or hobbies on holidays. There is not any educational intervention between patient and peer at 6 month to 12 month of the intervention. They just continue their relationship by telephone talking. at least all information will be recorded and measured at 12 month. An unblinded randomized clinical trial in which women with type 2 diabetes are divided into one of the two following categories: • control group: diabetic patients who received routine care includes attending small group class on diabetes diabetes class or education through national media) HbA1c. Timepoint: Before the intervention and at 3, 6 and 12 months after intervention. Method of measurement: HPLC. Fasting Blood Suger. Timepoint: Before the intervention and at 3, 6 and 12 months after intervention. Method of measurement: Glocose Oxidase. Total Cholestrol. Timepoint: Before the intervention and at 3, 6 and 12 months after intervention. Method of measurement: CHOD-Pap. Triglyseridi. Timepoint: Before the intervention and at 3, 6 and 12 months after intervention. Method of measurement: Gpo-pap. LDL. Timepoint: Before the intervention and at 3, 6 and 12 months after intervention. Method of measurement: photometery. HDL. Timepoint: Before the intervention and at 3, 6 and 12 months after intervention. Method of measurement: photometery. Body Mass Index. Timepoint: Before the intervention and at 3, 6 and 12 months after intervention. Method of measurement: weight (kg) / height (m)2. Blood Pressure. Timepoint: Before the intervention and at 3, 6 and 12 months after intervention. Method of measurement: Manometer (mmhg). Waist to Hip Ratio. Timepoint: Before the intervention and at 3, 6 and 12 months after intervention. Method of measurement: waist hip ratio measurement. Food intake. Timepoint: Before the intervention and at 3, 6 and 12 months after intervention. Method of measurement: The three-day recall questionnaire. Levels of physical activity. Timepoint: Before the intervention and at 3, 6 and 12 months after intervention. Method of measurement: International Physical Activity Questionnaire (IPAQ. Self-care activity. Timepoint: Before the intervention and at 3, 6 and 12 months after intervention. Method of measurement: summery of diabetes self-care activities- SDSCA. Quality of Life. Timepoint: Before the intervention and at 3, 6 and 12 months after intervention. Method of measurement: Diabetes Quality of Life (DQOL) Questionnaire. Depression. Timepoint: Before the intervention and at 3, 6 and 12 months after intervention. Method of measurement: Beck Depression Inventory. Social Capital. Timepoint: Before the intervention and at 3, 6 and 12 months after intervention. Method of measurement: Social Capital Integrated questionaire. Endocrinology & Metabolism Research Institute of Tehran University of Medical Sciences Approved 2014-12-28 lEthics Committee of Endocrinology and Metabolism Research Institute of Tehran University of Medic Shariati Hospital, North Karegar St. Tehran Iran (Islamic Republic of)