The Effects of Video Training Given to Individuals With Type 2 Diabetes

NCT06178094 | Completed

• 1 other identifier: E-69456409-199-35238
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomised control type of study is to examine the effects of Video Diabetes Training given to individuals with Type 2 Diabetes through smartphones on self-care and metabolic control. The Hypotheses of the Study: H1: Video Diabetes Training given to individuals with Type 2 Diabetes through smartphones has a positive impact on individuals' self-care. H2: Video Diabetes Training given to individuals with Type 2 Diabetes through smartphones has a positive impact on individuals' metabolic control variables. Participants will answer the data collection tools in the first and second interviews and metabolic control variables will be record. Diabetes training videos will sent to the Training Group through smartphones after the first meeting as two episodes a week. Video Diabetes Training given to training group will be examine the effects of on self-care and metabolic control.

Conditions

Diabetes Mellitus, Type 2; Training

Keywords

Diabetes training,; Metabolic control variables; Self-care; Type 2 Diabetes; Video training

Outcome Measures

Primary Outcomes (12)

• Numerical distribution of participants' sociodemographic and diabetes-related characteristics

  The sociodemographic and diabetes-related characteristics of the training and control groups. Sociodemographic characteristics; Age, gender, marital status, education level, occupation, income level, smoking and alcohol use were evaluated. Characteristics of diabetes: duration of diabetes, diabetes treatment method, use of other medications, family history of diabetes, frequency of check-ups, hospitalization due to high blood sugar, hospitalization due to hypoglycemia, chronic complications due to diabetes, previous education on diabetes, status other than diabetes the presence of the disease was evaluated.

  At the first meeting (initial)

• Diabetes Self-Care Scale mean score

  The comparison of Diabetes Self-Care Scale pre-test, post-test and change difference values between training and control groups. The lowest acceptable level of the scale is 92 points. The highest score that can be obtained from the scale is 140 points. As the score of the scale increases, patients' self-care activities also increase positively.

  At the first interview (baseline) and at the second interview 3 months later

• Fasting plasma glucose value

  Comparison of fasting plasma glucose variables between training and control groups. Fasting plasma glucose (mg/dl) value was obtained as a result of the participant's routine blood test.

  At the first interview (baseline) and at the second interview 3 months later

• HbA1c value

  Comparison of HbA1c variables between training and control groups. HbA1c (%) value was obtained as a result of the participant's routine blood test.

  At the first interview (baseline) and at the second interview 3 months later

• Total cholesterol value

  Comparison of total cholesterol variables between training and control groups. Total cholesterol (mg/dl) value was obtained as a result of the participant's routine blood test.

  At the first interview (baseline) and at the second interview 3 months later

• Low-density lipoprotein value

  Comparison of low-density lipoprotein variables between training and control groups. Low density lipoprotein (mg/dl) value was obtained as a result of the participant's routine blood test.

  At the first interview (baseline) and at the second interview 3 months later

• High-density lipoprotein value

  Comparison of high-density lipoprotein variables between training and control groups. High density lipoprotein (mg/dl) value was obtained as a result of the participant's routine blood test.

  At the first interview (baseline) and at the second interview 3 months later

• Triglyceride value

  Comparison of triglyceride variables between training and control groups. Triglyceride (mg/dl) value was obtained as a result of the participant's routine blood test.

  At the first interview (baseline) and at the second interview 3 months later

• Systolic blood pressure value

  Comparison of systolic blood pressure (mmHg) variables between training and control groups. The tools required for blood pressure measurement were provided by the researcher. The same measurement tools were used in the first interview (pretest) and the second interview (posttest). The participant was allowed to rest for at least 5-10 minutes before the measurement. An aneroid type sphygmomanometer, suitable for adults, was used as a measurement tool. In accordance with the technique recommended in the National Hypertension Treatment and Follow-up Guide, the researcher took measurements twice with an interval of two minutes while the participant was in a sitting position, with his right arm supported at heart level, and the results were recorded by averaging the measurements.

  At the first interview (baseline) and at the second interview 3 months later

• Diastolic blood pressure value

  Comparison of diastolic blood pressure (mmHg) variables between training and control groups. The tools required for blood pressure measurement were provided by the researcher. The same measurement tools were used in the first interview (pretest) and the second interview (posttest). The participant was allowed to rest for at least 5-10 minutes before the measurement. An aneroid type sphygmomanometer, suitable for adults, was used as a measurement tool. In accordance with the technique recommended in the National Hypertension Treatment and Follow-up Guide, the researcher took measurements twice with an interval of two minutes while the participant was in a sitting position, with his right arm supported at heart level, and the results were recorded by averaging the measurements.

  At the first interview (baseline) and at the second interview 3 months later

• Body Mass Index value

  Comparison of body mass index variables between training and control groups. To calculate the body mass index of the participants, they were measured according to the weight and height technique. Participants' BMI was calculated by dividing their weight by the square of their height \[BMI: Weight (kg)/height (m2)\]. BMI was evaluated in accordance with WHO recommendations.

  At the first interview (baseline) and at the second interview 3 months later

• Waist circumference value

  Comparison of waist circumference variables between training and control groups. Waist circumference measurement was made using the measurement technique recommended by WHO. While the participants were standing, the circumference was measured with a tape measure over their underwear, at the midpoint between the lowest rib and the crista iliaca at the end of expiration.

  At the first interview (baseline) and at the second interview 3 months later

Study Arms (2)

Video Diabetes Training group

EXPERIMENTAL

The data collection tools will apply in the first and second interviews and metabolic control variables will record. Diabetes training videos will sent to the Training Group through smartphones after the first meeting as two episodes a week.

Behavioral: Video Training

control group

NO INTERVENTION

The data collection tools will apply in the first and second interviews and metabolic control variables will record.

Interventions

Video Training BEHAVIORAL

The participants in the Training Group is to sent a total of eight episodes of the Diabetes Training Videos prepare by the researcher, twice a week, through smartphones after the first interview

Video Diabetes Training group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• agreed to participate in the study voluntarily,
• were diagnosed with Type 2 Diabetes for at least 6 months,
• were 18 years of age or older,
• were literate, had smartphones with video playback features and internet,
• without a physician diagnosis that would prevent communication, and psychiatric problems and hearing problems
• those who did not have sensory losses such as vision or hearing.

Sponsors & Collaborators

• Kırklareli University: lead

Study Sites (1)

Kırklareli University

Kırklareli, 39100, Turkey (Türkiye)

Location

Related Publications (8)

• Kang J, Chen Y, Zhao Y, Zhang C. Effect of remote management on comprehensive management of diabetes mellitus during the COVID-19 epidemic. Prim Care Diabetes. 2021 Jun;15(3):417-423. doi: 10.1016/j.pcd.2020.12.004. Epub 2021 Jan 1.

  PMID: 33422431 BACKGROUND

• Hansen CR, Perrild H, Koefoed BG, Zander M. Video consultations as add-on to standard care among patients with type 2 diabetes not responding to standard regimens: a randomized controlled trial. Eur J Endocrinol. 2017 Jun;176(6):727-736. doi: 10.1530/EJE-16-0811. Epub 2017 Mar 21.

  PMID: 28325823 RESULT

• Lee NP, Fisher WP Jr. Evaluation of the Diabetes Self-Care Scale. J Appl Meas. 2005;6(4):366-81.

  PMID: 16192661 RESULT

• Avdal EU, Uran BNO, Pamuk G, Yildirim JG, Konakci G, Ates M, Polat G. Investigation of the effect of web-based diabetes education on metabolic parameters in people with type 2 diabetes: A randomized controlled trial. J Infect Public Health. 2020 Dec;13(12):1892-1898. doi: 10.1016/j.jiph.2020.03.008. Epub 2020 May 20.

  PMID: 32444190 RESULT

• Bell AM, Fonda SJ, Walker MS, Schmidt V, Vigersky RA. Mobile phone-based video messages for diabetes self-care support. J Diabetes Sci Technol. 2012 Mar 1;6(2):310-9. doi: 10.1177/193229681200600214.

  PMID: 22538140 RESULT

• Rasmussen OW, Lauszus FF, Loekke M. Telemedicine compared with standard care in type 2 diabetes mellitus: A randomized trial in an outpatient clinic. J Telemed Telecare. 2016 Sep;22(6):363-8. doi: 10.1177/1357633X15608984. Epub 2015 Oct 14.

  PMID: 26468213 RESULT

• Sun C, Sun L, Xi S, Zhang H, Wang H, Feng Y, Deng Y, Wang H, Xiao X, Wang G, Gao Y, Wang G. Mobile Phone-Based Telemedicine Practice in Older Chinese Patients with Type 2 Diabetes Mellitus: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Jan 4;7(1):e10664. doi: 10.2196/10664.

  PMID: 30609983 RESULT

• Tang PC, Overhage JM, Chan AS, Brown NL, Aghighi B, Entwistle MP, Hui SL, Hyde SM, Klieman LH, Mitchell CJ, Perkins AJ, Qureshi LS, Waltimyer TA, Winters LJ, Young CY. Online disease management of diabetes: engaging and motivating patients online with enhanced resources-diabetes (EMPOWER-D), a randomized controlled trial. J Am Med Inform Assoc. 2013 May 1;20(3):526-34. doi: 10.1136/amiajnl-2012-001263. Epub 2012 Nov 20.

  PMID: 23171659 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• İlknur METİN AKTEN, PhD,MSc,RN

  Kırklareli University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: December 20, 2023
• Study Start: February 21, 2022
• Primary Completion: April 5, 2022
• Study Completion: August 19, 2022
• Last Updated: December 29, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)