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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

The Effects of Video Training Given to Individuals With Type 2 Diabetes Through Smartphones on Self-Care and Metabolic Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06178094
• Other study ID #: E-69456409-199-35238
• Status: Completed
• Phase: N/A
• Start date: February 21, 2022
• Est. completion date: August 19, 2022

Study information

• Verified date: December 2023
• Source: Kirklareli University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The study will conduct to examine the effects of Video Diabetes Training given to individuals with Type 2 Diabetes through smartphones on self-care and metabolic control.

This experimental, randomized, and controlled study will conduct with a total of 112 individuals with Type 2 Diabetes (56 in the Training Group, and 56 in the Control Group), who apply to the Internal Medicine Clinic of a state hospital in the Mediterranean Region of Turkey between February and August 2022, who volunteered to participate in the study and met the inclusion criteria.

A total of 112 individuals with Type 2 Diabetes, who volunteered to participate in the study, and met the inclusion criteria, will select with the Simple Random Sampling Method and will randomize with the help of a computer program.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: August 19, 2022
• Est. primary completion date: April 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

-Individuals who did not meet the inclusion criteria.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Training

Intervention

Behavioral:
• Video Training
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

Locations

Country	Name	City	State
Turkey	Kirklareli University	Kirklareli

Sponsors (1)

Lead Sponsor	Collaborator
Kirklareli University

Country where clinical trial is conducted

Turkey, 

References & Publications (8)

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 — View Citation

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. — View Citation

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- — View Citation

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. — View Citation

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

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. — View Citation

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 — View Citation

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 enh — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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