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临床试验/NCT05983120
NCT05983120已完成不适用

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

Afyonkarahisar Health Sciences University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年8月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Determination of self-regulation capacity from the principles of SCLT.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Determination of self-regulation capacity from the principles of SCLT.

时间窗: twelve weeks

There is no specific score range.High scores on the scale indicate good self-management (SMQ), and low scores indicate poor self-management. In the intervention group, no significant change was observed in SMQ general score averages between PT2 and IT values compared to PT1. Similarly, no significant change was observed in PT2 values compared to PT1 regarding the control group score averages.

Determination of self-judgment capacity, one of the principles of SCLT.

时间窗: twelve weeks

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. In the study, while the overall median score of DSMS in the intervention group showed a significant decrease in PT2 and IT values compared to PT1, no significant change was observed in the median DSMS scores of the control group.

Determining the effect of SCLT-based education on Quality of Life

时间窗: twelve weeks

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. In the intervention group, no significant change was observed in the median values of physical health, psychological health, social relations, and environmental health, which are WHOQOL subscales, in PT2 and IT values compared to PT1. Compared to PT1 regarding the median score of the control group's social relations, a minimum significant increase was observed in PT2 values, but no significant change was found in other subscales

次要结局

  • Determination of blood HbA1c value.(twelve weeks)
  • Determination of Fasting Blood Glucose (FBS) value.(twelve weeks)
  • Determination of blood Postprandial Blood Glucose (PBS) value.(twelve weeks)
  • Determination of blood fasting lipid profile (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglyceride) values.(twelve weeks)

研究者

发起方
Afyonkarahisar Health Sciences University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yasemin Çelik

Dr. assistant professor

Afyonkarahisar Health Sciences University

研究点 (1)

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