An interventional study of Interactive video training and Standard Nursing Care in Type 2 Diabetes and Outpatient, sponsored by Abant Izzet Baysal University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Abant Izzet Baysal University · Not applicable, Interventional, and Supportive care
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.
This doctoral thesis study is designed as a parallel-group, single-blind, randomized controlled interventional trial aimed at evaluating the effects of an interactive video-based self-management education program on glycemic control, self-management behaviors, and empowerment in individuals with type 2 diabetes. To ensure methodological transparency and adherence to established scientific reporting standards, the detailed study protocol is planned to be published as a separate scientific article.
Eligible adults with type 2 diabetes will be randomly assigned in a 1:1 ratio to either the intervention or control group. Block randomization with a fixed block size of six will be used to maintain balanced group allocation throughout the study period. The randomization sequence will be generated using a computer-based random number system by an independent individual who is not involved in participant recruitment, intervention delivery, or outcome assessment.
Prior to the main trial, a pilot study will be conducted to assess the acceptability and usability of the developed interactive video-based education program. Findings from the pilot study will be used solely to refine the intervention content and research procedures and will not be included in the sample or final analyses of the main trial. The results of the pilot study are also planned to be reported in a separate scientific publication.
Participants assigned to the intervention group will receive an interactive video-based diabetes self-management education program developed in accordance with the American Association of Diabetes Educators' AADE7 Self-Care Behaviors framework. The educational content will be structured around scenario-based representations of self-care behaviors that individuals with diabetes are expected to perform in their daily lives. The scenarios will be enacted by an individual assuming the role of a patient and will realistically reflect situations commonly encountered in everyday life. Each educational video will have an approximate duration of 5-10 minutes.
The video-based intervention will address the following AADE7 domains: Healthy Coping, Healthy Eating, Being Active, Taking Medication, Monitoring, Reducing Risk, and Problem Solving. Content validity will be established through expert review, with the scenarios evaluated by 10 experts experienced in nursing and internal medicine. Revisions will be made based on expert feedback, and the appropriateness of the educational materials will be assessed using the Davis technique. The finalized scenarios will subsequently be produced as educational videos.
The videos will be converted into an interactive format by incorporating elements such as question-and-answer segments, fill-in-the-blank activities, pop-up informational screens, and highlighted content areas. When participants provide incorrect responses to interactive questions, an explanatory video segment presenting the correct answer will be displayed, with the aim of supporting active learning and enhancing knowledge retention.
Participants in the control group will continue to receive standard routine care. Baseline assessments will be conducted prior to group allocation, and outcome measures will be evaluated at baseline and follow-up to assess changes in glycemic control, diabetes self-management, empowerment, and quality of life. In addition, participants' satisfaction with the educational materials will be assessed at the 3-month follow-up using the Satisfaction Evaluation Form.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 60 is below the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Abant Izzet Baysal University is the lead sponsor of 250 studies on the registry; 59 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Standard Nursing Care
Behavioral: Interactive video training · Behavioral: Standard Nursing Care
The 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.
Also known as: Interactive video education
Standard 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.
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-up
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-up
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-up
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-up
Fasting plasma glucose (FPG)
Fasting plasma glucose (FPG) will be used to assess glycemic control and is defined as the plasma glucose concentration measured after at least 8 hours of overnight fasting.
Time frame: Baseline (prior to intervention) and at 3-month follow-up
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-up
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-up
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-up
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-up
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Apr 2027, 5 months later.
Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 5 months is below that.
Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 9, 2026: start Aug 2026 → Nov 2026, primary completion Nov 2026 → Apr 2027 and completion Nov 2026 → Jul 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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