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

NCT ID: NCT06963073

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-15
• Study Completion Date: 2025-12-30

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Diabetic DM

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.).

Group Type: EXPERIMENTAL

Diabetic DM

Intervention Type: OTHER

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.

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Diabetes training

Eligibility Criteria

Inclusion Criteria

1. Volunteering to participate in the study.

2. Having recently been diagnosed with Type 2 Diabetes.

3. Not having cognitive dysfunction.

4. Not having done diabetes education before.

Exclusion Criteria

1. Being under 18 years of age.

2. Having cognitive dysfunction.

3. Not volunteering to participate in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Çanakkale Onsekiz Mart University

OTHER

Sponsor Role: lead

Responsible Party

Naile ALANKAYA

Associate Professor, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

NAİLE ALANKAYA, Assosiate Prof.

Role: STUDY_DIRECTOR

Çanakkale Onsekiz Mart University, Faculty of Health Sciences

Locations

Çanakkale Onsekiz Mart University, Faculty of Health Sciences

Çanakkale, , Turkey (Türkiye)

Çanakkale Onsekiz Mart University, Faculty of Health Sciences

Çanakkale, Çanakkale, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Naile Alankaya, Assosiate Prof. PhD

Role: CONTACT

nailealankaya@comu.edu.tr

+905334256510

Ceyda Albayrak

Role: CONTACT

ceycealbayrak@gmail.com

+905488860535

Facility Contacts

Naile Alankaya, Assoc. Prof.

Role: primary

nailealankaya@comu.edu.tr

+905334256510

Other Identifiers

COMU-SBF-NA-01

Identifier Type: -

Identifier Source: org_study_id