Self-management and Quality of Life in Individuals With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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The study was conducted in order to study the effect of the training given according to social-cognitive learning theory (SCLT) upon diabetes self-management and quality of life among type 2 diabetes mellitus individuals.

Detailed Description
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The study was done as a randomized-controlled experimental study at Internal Diseases Polyclinics of Afyonkarahisar Public Hospital between November 2021 and August 2022. The study was completed with 60 patients -experimental group (30 patients) and control group (30 patients)- who met inclusion criteria. The data were gathered using Information Request Form and Metabolic Variables Form, Diabetes Self-Management Scale (DSMS) for Type 2 Diabetic Patients, Multidimensional Scale of Perceived Social Support (MSPSS), Type 2 Diabetes Mellitus Self-Management Questionnaire (SMQ), WHOQOL-BREF (WHO- Quality of Life Scale- Short form). A theoretical and practical training based on SCLT was provided to the experimental group for the first five weeks -one module for each week- through power point presentations and afterwards, SMS reminders were sent every fifteen days for seven weeks and at the end of the twelfth week the training was completed. The control group received a standard training from diabetes nurse. The data were assessed using statistical methods.

Official Title
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The Effect of Education Provided According to Social Cognitive Learning Theory on Diabetes Self-management and Quality of Life in Individuals With Type 2 Diabetes Mellitus

Conditions
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Pre-Existing Type 2 Diabetes Mellitus

Intervention / Treatment
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* Other: Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years and over Being diagnosed with Type 2 diabetes mellitus, Being on insulin therapy, Being open to verbal communication, Being literate Not to have an obstacle to continue the implementation phase of the research (for example, pregnancy plan, changing province, etc.) Not having hearing-vision problems and diabetes-related serious neuropathy (amputation, etc.), Patients who agreed to participate in the study. Exclusion Criteria:The patient has a perception disorder and psychiatric disorder that prevents communication, Being pregnant, Individuals with serious complications such as retinopathy and neuropathy at the level of blindness were excluded from the study. Research Termination Criteria Not performing the specified applications properly during the study, Unreachable in follow-ups, Those who want to quit working, Serious complications related to comorbid diseases and diabetes that occur during the working process, The study was terminated with patients who were moved out of the province during the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Training group<br>In the first five weeks, the experimental group was given training consisting of five modules, accompanied by power point presentations and applied social cognitive learning theory, then SMS reminders were sent every fortnight for seven weeks, and the study was completed at the end of the twelfth week. The control group received standard training from a diabetes nurse. Scale evaluations, metabolic and anthropometric measurements were made at the beginning and end of the study in the experimental and control groups. In addition, the scale evaluation was repeated in the fifth week for the experimental group. Data were evaluated using appropriate statistical methods. | Other: Education<br>* Educate the patients who suffer from Type 2 Diabetes Mellitus<br>|
| No Intervention: Control Group<br>The control group received standard training from a diabetes nurse. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determining the principle of mutual determination from the principles of the social cognitive learning theory (SCLT) | It was evaluated with the Multidimensional Scale of Perceived Social Support (MSPSS). The lowest score that can be obtained from the entire scale is 12, and the highest score is 84. A high score indicates high perceived social support. | twelve weeks | 
| Determination of self-regulation capacity from the principles of SCLT. | There is no specific score range.High scores on the scale indicate good self-management (SMQ), and low scores indicate poor self-management. | twelve weeks | 
| Determination of self-judgment capacity, one of the principles of SCLT. | DM was assessed with the Self-Efficacy Scale (DSMS). The lowest score that can be obtained from the scale is 20, and the highest score is 100. In the sample, the scale score average is calculated and individuals who are above the average are evaluated as high self-efficacy, and individuals below the average are evaluated as low self-efficacy. | twelve weeks | 
| Determining the effect of SCLT-based education on Quality of Life | Evaluated by WHOQOL - BREF (World Health Organization Quality of Life Scale - Short Form). It has four sub-dimensions: physical health such as pain, sleep, energy, psychological health such as positive emotions, self-confidence, body image, social relations such as social support, personal relations and environmental health such as economic status, transportation, safe environment and health conditions. A high score indicates a high quality of life. | twelve weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of blood HbA1c value. | HbA1c (glycosylated hemoglobin). Indicates the average blood glucose value over the last 2 to 3 months. The HbA1c reference range should be 5.7-6.4%. HbA1c level ≥6.5% or ≤5.6 poor glycemic control. | twelve weeks | 
| Determination of Fasting Blood Glucose (FLA) value. | It is the glucose value (plasma glucose) measured from a blood sample taken after eight or twelve hours of fasting. The normal reference range is min 80 mg/dl - max 130 mg/dl. FLA level ≥130 mg/dl or ≤80 mg/dl poor glycemic control. | twelve weeks | 
| Determination of blood Postprandial Blood Glucose (TKS) value. | TCS is the plasma glucose value measured two hours after the start of food intake after an eight-hour fast. The reference range is 140-199 mg/dl. TKS ≥200 mg/dl or ≤139 mg/dl a weak glycemic control. | twelve weeks | 
| Determination of blood fasting lipid profile (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglyceride) values. | A blood sample taken after eight or twelve hours of fasting is used to determine the fasting lipid profile (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglyceride) values. Fasting lipid profile reference range is (Total cholesterol 20 - 200 mg/dl, High Density Lipoprotein (HDL) reference range is 35 - 65 mg/dl, Low Density Lipoprotein (LDL) reference range is 60 - 130 mg/dl, Triglyceride reference range is 20 - 203 mg/dl). Values less or higher than the specified values are considered as negative cholesterol levels. | twelve weeks | 
| Determination of Body Mass Index (BMI) | BMI is calculated by dividing body weight (kg) by height (m) squared (kg/m²). Results below 18.5 kg/m²: Below ideal weight Results between 18.5 kg/m² and 24.9 kg/m²: At ideal weight Results from 25 kg/m² to 29.9 kg/m²: Above ideal weight Results between 30 kg/m² and 39.9 kg/m²: Well above ideal weight (obese) Results over 40 kg/m²: It is considered as well above the ideal weight (morbidly obese). | twelve weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes, Social Cognitive Learning, Diabetes Self-management, Quality of Life