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Not yet recruiting NCT06963073

The Effect of Education and Tele-Follow-Up Program on Diabetes Self-Management and Blood Glucose Regulation

No phase Interventional Diabetes Mellitus, Type 2

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Diabetic DM.
Who it may be relevant to
Registry conditions: Diabetes Mellitus, Type 2. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Other Diabetic DM
    The intervention group will receive 45 minutes of diabetes education. Three telemonitoring sessions will be held 2 weeks, 1 month and 3 months after the education. During the monitoring, participants will be asked to monitor their blood sugar and HbA1C values, if any. Nothing will be done to the control group. The same monitoring will be held for the control group 3 months later.

Primary outcome measures

  • Diabetes Self-Management Scale [Time frame: Baseline and after 6 months]
  • Adult Diabetes Knowledge Scale [Time frame: Baseline and after 6 months]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

Turkey (Türkiye) · 2 centers
  • Çanakkale Onsekiz Mart University, Faculty of Health Sciences — Çanakkale
  • Çanakkale Onsekiz Mart University, Faculty of Health Sciences — Çanakkale

Identifiers

NCT: NCT06963073 · COMU-SBF-NA-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗