Effect of Interactive Video-Based Self-Management Education in Adults With Type 2 Diabetes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAbant Izzet Baysal University
About this trial
This study aims to evaluate the effectiveness of an interactive video-based self-management education program for adults with type 2 diabetes. The education program is designed to support individuals in managing their daily diabetes care and improving their blood glucose control. Participants in this study will be adults diagnosed with type 2 diabetes who are receiving outpatient care. Eligible participants will be randomly assigned to either an intervention group or a control group. Participants in the intervention group will receive an interactive video-based education program developed according to the AADE7 Self-Care Behaviors framework. The videos are based on real-life scenarios and encourage active participation and decision-making. Participants in the control group will receive standard diabetes care. The study will assess changes in blood glucose control, diabetes self-management behaviors, and empowerment levels over the study period. Data will be collected using clinical measurements and questionnaires. Participation in this study is voluntary. The results of this study may contribute to improving diabetes education practices and supporting patient-centered care in clinical settings.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged between 18 and 65 years (Mumcu & İnkaya, 2022).
Able to read, write, understand, and speak Turkish.
Diagnosed with type 2 diabetes for at least one year (Onyia et al., 2023; Shahshahani et al., 2023).
Receiving oral antidiabetic agents and/or insulin therapy (Mikhael et al., 2019).
Disqualifiers
Having previously received video-based diabetes education.
Currently using or having previously used a video-based tool or program supporting type 2 diabetes management.
Having severe visual, auditory, cognitive impairments, or physical disabilities that may interfere with participation.
Being hospitalized as an inpatient during the intervention period.
Trial design
Design model
Parallel
Treatments tested in this trial
Interactive video training
BehavioralThe intervention is designed to promote active learning through decision-making, question-answer interactions, and scenario-based navigation within the video content. The education program is based on the AADE7 Self-Care Behaviors framework and covers healthy coping, healthy eating, physical activity, medication use, monitoring, risk reduction, and problem-solving. Videos are structured around real-life scenarios, performed by an actor portraying a patient, and each video lasts approximately 5-10 minutes. Participants will access the web-based videos via their personal smartphones and will be given one month to complete all content, with unlimited viewing allowed. Engagement will be monitored weekly, and reminders will be provided if no viewing occurs for one week. Interactive elements include embedded questions, feedback videos, and informational prompts. Participant satisfaction will be assessed at the 3-month follow-up.
Standard Nursing Care
BehavioralStandard nursing care is routinely provided at the outpatient clinic by a diabetes nurse educator in accordance with established institutional clinical protocols and educational practices. This care consists of face-to-face verbal education delivered during routine follow-up visits. Educational content generally includes core components of diabetes management, such as treatment approaches, self-monitoring of blood glucose, nutrition planning, physical activity recommendations, prevention of acute complications-particularly hypoglycemia-and daily self-care practices. Follow-up visits typically involve reviewing blood glucose records, assessing clinical status, and reinforcing self-management behaviors based on individual needs.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Standard Nursing CareActive comparator 1 intervention
Group B: Interactive video trainingExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
The Comprehensive Diabetes Self-Management Scale (CDSMS)
CDSMS is a patient-centered instrument developed to assess self-management behaviors in individuals with diabetes. The scale evaluates key domains of diabetes self-care, including healthy eating, physical activity, medication adherence, blood glucose monitoring, problem-solving, risk reduction, and healthy coping with stress.The CDSMS consists of 14 items (26 questions) with scores ranging from 0 to 4.The total score reflects overall diabetes self-management ability. The scale has demonstrated acceptable internal consistency (Cronbach's alpha=.70-.73) and has been validated for use in the Turkish population. Higher CDSMS scores are associated with better glycemic control, as indicated by HbA1c levels. In the ROC analysis, HbA1c ≤6.50 indicated good glycemic control and \>6.50 poor control. Scores below 21 were associated with poor glycemic control. The total CDSMS score is the sum of the seven domain scores and ranges from 0 to 28, with higher scores indicating better self-management.
Time frame
Baseline (prior to intervention) and at 3-month follow-up2
Hba1c
HbA1c will be used to assess glycemic control. Predefined HbA1c thresholds will be applied for descriptive and interpretive purposes, with lower values indicating better glycemic control and higher values indicating poorer control.
Time frame
Baseline (prior to intervention) and at 3-month follow-up3
Diabetes Empowerment Scale (DES)
The Diabetes Empowerment Scale (DES) is a validated and reliable self-report scale developed to assess the levels of psychosocial empowerment and self-efficacy in individuals with diabetes regarding diabetes management. The scale consists of three sub-dimensions: management of psychosocial aspects of diabetes, level of dissatisfaction and readiness for change, and setting and achieving diabetes goals. Items are scored from 1 to 5, and sub-dimension and total scores are calculated by averaging the relevant items. Each sub-dimension and total score ranges from 1 to 5. Lower scores indicate lower levels of psychosocial competence and empowerment related to diabetes, while higher scores indicate higher levels of empowerment.
Time frame
Baseline (prior to intervention) and at 3-month follow-up4
Estimated average glucose (ADAG)
Glycemic control will be evaluated using estimated average glucose (ADAG), which represents mean blood glucose over the previous 2-3 months and is calculated from HbA1c using the formula: ADAG (mg/dL) = (28.7 × HbA1c) - 46.7.
Time frame
Baseline (prior to intervention) and at 3-month follow-upSecondary outcomes
1
SF-12 Health Survey (Secondary Outcome)
The SF-12 Health Survey is a validated generic instrument developed to assess health-related quality of life over the previous four weeks, independent of age or disease group. The questionnaire consists of 12 items covering eight health domains and generates two summary scores: the Physical Component Summary (PCS-12) and the Mental Component Summary (MCS-12). PCS-12 reflects general health, physical functioning, physical role, and bodily pain, while MCS-12 represents social functioning, emotional role, mental health, and vitality. Scores range from 0 to 100, with higher scores indicating better health-related quality of life. The Turkish version of the SF-12 has demonstrated acceptable reliability for both physical and mental component scores. A high score on the scale indicates that the individual is in good health.
Time frame
Baseline (prior to intervention) and at 3-month follow-upOther outcomes
1
Other outcomes- Blood pressure
Blood pressure will be measured in mmHg after a period of rest to assess cardiovascular risk as part of diabetes management.
Time frame
Baseline (prior to intervention) and at 3-month follow-up2
Other outcomes- Body weight
Body weight will be measured in kilograms using a calibrated scale to evaluate changes in overall body mass related to diabetes management.
Time frame
Baseline (prior to intervention) and at 3-month follow-up3
Other outcomes- Waist circumference
Waist circumference will be measured in centimeters at the midpoint between the lowest rib and the iliac crest to assess central adiposity associated with metabolic risk in diabetes.
Time frame
Baseline (prior to intervention) and at 3-month follow-upSponsors and contacts
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Source ClinicalTrials.gov
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