type 1 diabetes. E10 Type 1 diabetes mellitus
Conditions
Interventions
Intervention 1: Intervention group: In this study, the intervention for each patient will be conducted over a period of 3 months, comprising 3 to 4 home visit sessions, along with daily follow-up thro
Sponsors
Shiraz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
8 Years to 16 Years
Inclusion criteria
Inclusion criteria: Be willing to participate in the study. Reside in the city where the study is conducted. The patient and the primary caregiver must be able to speak, read, and write in Persian. The patient’s age should be between 8 and 16 years. Have a history of type 1 diabetes for at least one year. Have a history of poor glycemic control, with glycated hemoglobin (HbA1c) above 8% in the past year. No family members of the patient should have type 1 diabetes. The patient and the primary caregiver should not have physical disabilities or cognitive, hearing, and visual impairments according to their own statements. Should not have participated in similar studies in the past six months. Should not have other metabolic, chronic, or incurable diseases. The patient and the primary caregiver should not have mental illnesses and should not be taking psychiatric medications. Should not be taking any medications other than those used for diabetes, such as steroids. The primary caregivers should not be employed in health-related professions.
Exclusion criteria
Exclusion criteria: The death of the patient or the primary caregiver occurs in the family. The patient and the caregiver do not attend the sessions (miss at least two sessions in one month). The patient or the primary caregiver is diagnosed with any incurable physical or mental illness during the study period. Any severe physical or emotional crisis occurs for the patient during the study period. The questionnaires used in the study are completed incompletely. Participates in similar educational sessions. The primary caregiver of the patient in the family is changed for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycosylated hemoglobin: comparison of the average "glycosylated hemoglobin percentage value" before and after the intervention, between the two test and control groups. Timepoint: Before the start of the intervention, after the intervention, 3 and 6 months after the intervention. Method of measurement: "High performance liquid chromatography" method will be used to measure glycosylated hemoglobin.;Lipid profile: Comparison of the average "lipid profile" before and after the intervention, between the two test and control groups. Timepoint: Before the start of the intervention, after the intervention, 3 and 6 months after the intervention. Method of measurement: In order to measure the "lipid profile" the "enzymatic colorimetry" method will be used.;Knowledge scores: Comparison of the average "Diabetes Self-Management Knowledge Scores" before and after the intervention, between the two test and control groups. Timepoint: Before the start of the intervention, after the intervention, 3 and 6 months after the intervention. Method of measurement: Knowledge assessment questionnaire for children/adolescents with diabetes ( M-WIKAD). | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life: comparing the average scores of "quality of life" before and after the intervention, between the two test and control groups. Timepoint: Before the start of the intervention, after the intervention, 3 and 6 months after the intervention. Method of measurement: PedsQL™ 4.0 Pediatric Quality of Life Inventory.;Missed dose of insulin frequency : Comparison of the average frequency of "missed dose of insulin" before and after the intervention between the test and control groups. Timepoint: Before the start of the intervention, after the intervention, 3 and 6 months after the intervention. Method of measurement: time diary : The tool for recording activity time and events, this tool includes tables about the frequency of self-monitoring of blood sugar, the duration of exercise and events such as the number of missed doses of insulin, the frequency of hypoglycemia ?and hyperglycemia, which are recorded on a daily basis.;The average duration of exercise per week: comparison of the average "duration of exercise per week" before and after the intervention between the two test and control groups. Timepoint: Before the start of the intervention, after the intervention, 3 and 6 months after the intervention. Method of measurement: time diary : The tool for recording activity time and events, this tool includes tables about the frequency of self-monitoring of blood sugar, the duration of exercise and events such as the number of missed doses of insulin, the frequency of hypoglycemia ?and hyperglycemia, which are recorded on a daily basis.;The average frequency of hypoglycemia in the week before and after the intervention between the two test and control groups. Timepoint: Before the start of the intervention, after the intervention, 3 and 6 months after the intervention. Method of measurement: time diary : The tool for recording activity time and events, this tool includes tables about the frequency of self-monitoring of blood sugar, the duration of exercise and | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAmin Kiani
Shiraz University of Medical Sciences
Outcome results
None listed