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临床试验/NCT06963073
NCT06963073尚未招募不适用

Effect of Education and Tele-Follow-Up Program Given to New Type 2 Diabetes Patients on Diabetes Self-Management and Blood Glucose Regulation

Çanakkale Onsekiz Mart University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年6月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
2
主要终点
Diabetes Self-Management Scale

研究概览

简要总结

This study is designed as a randomized controlled trial to determine the effects of education and the Tele-Follow-up program on the disease knowledge, self-management, and blood glucose regulation of newly diagnosed Type 2 diabetes patients.

详细描述

The population for this study consists of newly diagnosed Type 2 diabetes patients who visit the Dr. Burhan Nalbantoğlu Hospital. This study was planned as a randomized controlled trial. In the study, simple randomization design was preferred among experimental designs. Computer-generated random numbers method was used in sample size calculation. The sample size was calculated using the "G. Power-3.1.9.2" program, and the minimum required sample size for the study was determined before data collection at a 95% confidence level. According to the calculation, for the independent sample t-test with a 0.05 alpha value, a 1.128 effect size, and a theoretical power of 95%, the minimum sample size was determined to be 44 participants (22 per group). By considering that there might be losses in the study, it is planned to include a total of 60 patient in the study.

Data collection will take place in three stages.

  1. All participants eligible for the study (both experimental and control groups) will be required to complete the "Demographic Information Form," the "Adult Diabetes Knowledge Scale" to assess their knowledge about the disease, and the "Diabetes Self-Management Scale" to evaluate their diabetes self-management. Blood glucose levels and Hemoglobin A1c (HbA1c) values will be obtained from the patients' hospital records on the day of measurement. For Body Mass Index (BMI), the researcher will measure the patients' height and weight, and BMI will be calculated. In the randomized experimental group, participants will receive one-on-one face-to-face diabetes education in a dedicated training room, delivered via a PowerPoint presentation prepared by the researcher, using a computer. At the end of the training, an educational booklet will be provided. Participants in the control group will receive only the educational booklet prepared by the researcher, without any formal education. After three months, participants in the control group will be informed that they will receive individual education at the end of the study.
  2. Participants who attended the training will be contacted by phone at least three times-two weeks, one month, and two months after the training. The effects of the education on diabetes management will be evaluated, home-monitored blood glucose levels will be inquired and recorded, and additional education will be provided where necessary.
  3. Three months after the initial planned education and following telemonitoring (after at least three follow-up phone calls), the "Adult Diabetes Knowledge Scale" and the "Diabetes Self-Management Scale" will be re-administered by the patients in order to evaluate the impact of the education on diabetes management. If available, fasting blood glucose and Hemoglobin A1c values will be obtained from the hospital records on the corresponding date. Participants in the control group will also be asked to complete the same questionnaires again. After the data collection process is completed, the same planned education will be provided to participants in the control group as well, in order to eliminate any potential disadvantage or ethical concerns.

The data collection tools to be used in this study include the Descriptive Characteristics Form, the Adult Diabetes Knowledge Scale, and the Diabetes Self-Management Scale.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Volunteering to participate in the study.
  • •Having recently been diagnosed with Type 2 Diabetes.
  • •Not having cognitive dysfunction.
  • •Not having done diabetes education before.

排除标准

  • •Being under 18 years of age.
  • •Having cognitive dysfunction.
  • •Not volunteering to participate in the study.

研究组 & 干预措施

Control group

No Intervention

The control group will consist of 30 people. No training will be given to this group. Only a brochure containing brief diabetes information will be given.

Diabetic DM

Experimental

The intervention group will consist of 30 people. This group will be given 45 minutes of diabetes education (nutrition, exercise, medication, treatment, insulin administration, etc.).

干预措施: Diabetic DM (Other)

结局指标

主要结局

Diabetes Self-Management Scale

时间窗: Baseline and after 6 months

As a result of the study by Koç and his colleagues, a new measurement tool called "Type 2 Diabetes Self-Management Scale" was developed. A minimum of 19 and a maximum of 95 points can be obtained from the scale. There is no cut-off score range for the scale. According to the total score average, high scores indicate good self-management, while low scores indicate poor self-management.

Adult Diabetes Knowledge Scale

时间窗: Baseline and after 6 months

The scale was developed by Erener Yavuz and Erol (2019) to measure the knowledge levels of adult diabetic individuals. The maximum score that can be obtained from the scale is 28, and the minimum score is 0. Scores between 14 and 28 indicate a high level of knowledge, while scores below 14 indicate insufficient level of knowledge.

次要结局

未报告次要终点

研究者

发起方
Çanakkale Onsekiz Mart University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Naile ALANKAYA

Associate Professor, PhD

Çanakkale Onsekiz Mart University

研究点 (2)

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