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IRCT20190730044386N1 IRCT 2020-12-12 Esfahan University of Medical Sciences The effect of home care on quality of life, re-admission and HbA1C of patients with diabetes The effect of home care on glycosylated hemoglobin, quality of life, and readmission of patients with type 2 diabetes who have undergone surgery and are being discharged from selected training centers 2019-07-22 anticipated 70 Complete https://irct.ir/trial/42993 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Random allocation by blocking method will be done as follows: The researcher will divide the total sample size into smaller groups (groups of four) called blocks, considering that with a sample size of 70 and a quadruple block, an integer is not obtained, so we consider the number 72 and as a result we will have eighteen blocks. . The situations of placing people (four people) inside each block can be imagined and documented from the total number of samples from the intervention and control group {ACAC, ACCA, CCAA, CAAC, AACC, CACA )then assign a number to each of these blocks .ACAC = 1, ACCA = 2, CCAA = 3CAAC = 4, AACC = 5, CACA = 6 )) We write the numbers on the balls of the same color and size and put them in the bag, and The three-year-old then pulls a ball out of the bag and, after recording the number on the ball, returns it to the bag and pulls out the next ball. In this way, during the sampling, according to the order of the blocks and the number taken out of the bag, sampling will be done. It is necessary to explain that the previous block must be completed to complete the next block, Blinding description: In patient blinding, the researcher will explain the purpose of the study to both groups equally before randomly allocated the samples. Consent to participate in the study will be obtained from each participant in the study. Quality of life questionnaire for each of patients will be completed and a blood sample will be taken for glycosylated hemoglobin. Then, according to the block number (in which the four samples should be placed)patients will be randomly placed in intervention or control groups. Because sampling will be done on different days and in the morning and evening shifts, patients in the control and intervention groups will not be able to communicate with each other. In this study, blindness will also be performed for the statistical analyst. For this purpose, the letters A and B will be used to enter the data of the intervention and control group, and the analyst will not be aware of which letter belongs to which group under study. N/A Diabetes Mellitus. Intervention 1: Intervention group: Home careInterventions in the test group include the following.A working team will be formed consisting of a nurse with 14 years of clinical experience (master's degree student in nursing) and her supervising professors (a PhD in nursing and an endocrinologist) a general surgeon and a dietitian.1- Quality of life questionnaire and background characteristics will be completed by patients at the beginning of the study2. Blood samples will be taken from patients to perform glycosylated hemoglobin test3- The first home visit will be done in the first 24 hours after discharge to determine and prioritize the patient's educational, care, treatment and support needs.4- Planning to cover the prioritized needs will be done in a meeting with other team members.5- The nurse will have scheduled visits to the patients' homes for 3 months to perform educational and care interventions, including changing the dressing , measuring blood sugar and teaching self management behaviors.The duration of home visits is estimated at least three hours per week in the first month, and in the second and third months,depending on the patient's needs, the frequency and duration of home care will vary.6- In addition to the scheduled visits, the nurse (researcher) telephone number will be provided to the family, who will contact the nurse in case of emergency and, if necessary, an additional home care session will be planned and performed.8-The medical needs of the patient will be covered by the team doctor in two ways. a- The nurse, in coordination with the doctor, will collect the necessary information in the patient's home and transfer it to the doctor.The doctor will then make the necessary treatment recommendations to the nurse based on the information received, and the nurse will follow the doctor's orders at home.B- If necessary, the doctor will personally visit the patient at home.8. The patient's nutrition pattern will be evaluated and information will be provided to the team dietitian.dietitian's recommendations based on the patient's needs will be taught to the patient and family at the nurse's next visit.13. The readmission questionnaire will be completed by the nurse each time the patient is readmitted for three months.14- At the end of the third month, a blood sample for HbA1C will be sent to the laboratory again.At the end of the third month, patients will complete the quality of life questionnaire again. Intervention 2: Control group:1- Quality of life questionnaire and background characteristics will be completed by patients at the beginning of the study2. Blood samples will be taken from patients to perform glycosylated hemoglobin test.3-Patients will be informed that they will be referred three months later to complete the Quality of Life Questionnaire and take a blood sample for HbA1C .4-.At the beginning of the study, the readmission questionnaire will be provided to patients. They will be taught how to complete the questionnaire and they will be asked to complete the questionnaire each time they are readmitted for three months.5- The nurse's phone number is provided to the patients so that they can contact them if they have any questions about completing the readmission questionnaire.6- The nurse will make a monthly phone call to the patients to remind them about completing the readmission questionnaire and that they will be referred to them by the end of the third month to test for glycosylated hemoglobin and complete the quality of life questionnaire. 7- Patients in the control group will not receive any care and treatment from the research team during the study period. 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 Confidentiality of participants' information
public Parvaneh Abazari
Fourth Floor, No 6, 18th Alley, Friborg Street
Esfahan Iran (Islamic Republic of) 8168783546 +98 31 3668 9207 abazari@nm.mui.ac.ir Esfahan University of Medical Sciences scientific Parvaneh Abazari
Fourth Floor, No 6,18th Alley, Friborg Street
Esfahan Iran (Islamic Republic of) 8763453565 0098317927543 abazari@nm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients living in the geographical area of Isfahan Persian language Able to communicate verbally type2 diabetes Consent to participate in research inpatient in surgical wards with discharge order Consent the family to participate in the research at least 45 years old 45 years no limit Both E11 Type 2 diabetes mellitus Rehabilitation N/A Intervention group: Home careInterventions in the test group include the following.A working team will be formed consisting of a nurse with 14 years of clinical experience (master's degree student in nursing) and her supervising professors (a PhD in nursing and an endocrinologist) a general surgeon and a dietitian.1- Quality of life questionnaire and background characteristics will be completed by patients at the beginning of the study2. Blood samples will be taken from patients to perform glycosylated hemoglobin test3- The first home visit will be done in the first 24 hours after discharge to determine and prioritize the patient's educational, care, treatment and support needs.4- Planning to cover the prioritized needs will be done in a meeting with other team members.5- The nurse will have scheduled visits to the patients' homes for 3 months to perform educational and care interventions, including changing the dressing , measuring blood sugar and teaching self management behaviors.The duration of home visits is estimated at least three hours per week in the first month, and in the second and third months,depending on the patient's needs, the frequency and duration of home care will vary.6- In addition to the scheduled visits, the nurse (researcher) telephone number will be provided to the family, who will contact the nurse in case of emergency and, if necessary, an additional home care session will be planned and performed.8-The medical needs of the patient will be covered by the team doctor in two ways. a- The nurse, in coordination with the doctor, will collect the necessary information in the patient's home and transfer it to the doctor.The doctor will then make the necessary treatment recommendations to the nurse based on the information received, and the nurse will follow the doctor's orders at home.B- If necessary, the doctor will personally visit the patient at home.8. The patient's nutrition pattern will be evaluated and information will be provided to the team dietitian.dietitian's recommendations based on the patient's needs will be taught to the patient and family at the nurse's next visit.13. The readmission questionnaire will be completed by the nurse each time the patient is readmitted for three months.14- At the end of the third month, a blood sample for HbA1C will be sent to the laboratory again.At the end of the third month, patients will complete the quality of life questionnaire again. Control group:1- Quality of life questionnaire and background characteristics will be completed by patients at the beginning of the study2. Blood samples will be taken from patients to perform glycosylated hemoglobin test.3-Patients will be informed that they will be referred three months later to complete the Quality of Life Questionnaire and take a blood sample for HbA1C .4-.At the beginning of the study, the readmission questionnaire will be provided to patients. They will be taught how to complete the questionnaire and they will be asked to complete the questionnaire each time they are readmitted for three months.5- The nurse's phone number is provided to the patients so that they can contact them if they have any questions about completing the readmission questionnaire.6- The nurse will make a monthly phone call to the patients to remind them about completing the readmission questionnaire and that they will be referred to them by the end of the third month to test for glycosylated hemoglobin and complete the quality of life questionnaire. 7- Patients in the control group will not receive any care and treatment from the research team during the study period. HbA1C. Timepoint: At the beginning of the study and 3 months later. Method of measurement: Chromatography. Quality of life. Timepoint: At the beginning of the study and three months later. Method of measurement: Questionnaire. Readmission. Timepoint: At the beginning of the study and three months later. Method of measurement: Questionnaire. Esfahan University of Medical Sciences Approved 2019-07-20 Ethics committee of Esfahan University of Medical Sciences Fourth Floor,No 6,18th Alley,Friborg Street Esfahan Isfehan Iran (Islamic Republic of)