The Effect Of An Interactive Video-Based Self-Management Education On Glycemic Control, Self-Management and Empowerment İn Individuals With Type 2 Diabetes: A Parallel-Group, Single-Blind, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The Comprehensive Diabetes Self-Management Scale (CDSMS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
This study uses a single-blind design. Due to the nature of the intervention, the researcher delivering the intervention cannot be blinded. However, participants will not be informed whether they are assigned to the intervention or control group during data collection. To ensure blinding during data analysis, all study data will be coded using non-identifiable group labels (e.g., Group A/B or Group 1/2). The coded dataset will be provided to an independent statistician, who will be blinded to group allocation during statistical analysis and reporting. This approach is intended to minimize bias and ensure objectivity in outcome evaluation.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
- •Having an HbA1c level >7% in at least one measurement within the last 3 months (Hu et al., 2023; Lee et al., 2020; Asmat et al., 2023; TEMD, 2024).
- •Volunteering to participate in the study.
- •Owning a personal device (e.g., smartphone) capable of playing interactive videos.
- •Having the ability to use a smartphone capable of playing interactive videos, which will be assessed by observing the participant using an interactive video -not related to the study intervention.
- •Owning a smartphone with an active internet data plan.
- •Being able to attend scheduled follow-up visits at the frequency required for study measurements.
- •Having a body mass index (BMI) ≥18.5 kg/m² (Lee et al., 2022).
- •Not following a vegan or vegetarian diet (Dening et al., 2023).
- •Having hemoglobin levels within normal ranges (women: 12-16 g/dL; men: 14-18 g/dL) (Billett, 1990).
排除标准
- •xclusion Criteria:
- •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.
- •Being pregnant, planning pregnancy within the next 6 months, or becoming pregnant during the study.
- •Breastfeeding during the study period (due to potential dietary restrictions).
- •Using any weight-loss medication or supportive pharmacological agent.
- •Having a diagnosis of sickle cell anemia or being diagnosed during the study period (TEMD, 2024, p.18; Eyth et al., 2025).
- •Receiving hemodialysis, having experienced recent bleeding or blood transfusion, or receiving erythropoietin therapy (TEMD, 2024, p.18; Eyth et al., 2025).
- •Having a diagnosed psychiatric disorder (e.g., major depressive disorder, bipolar disorder, schizophrenia).
- •Participating in another diabetes-related intervention or program during the study period.
- •Using an insulin pump (Lee et al., 2022).
- •Managing diabetes with nutrition therapy alone without pharmacological treatment.
- •Following a diet prescribed and supervised by a dietitian due to another medical condition or surgical procedure.
研究组 & 干预措施
Standard Nursing Care
干预措施: Standard Nursing Care (Behavioral)
Interactive video training
干预措施: Standard Nursing Care (Behavioral)
Interactive video training
干预措施: Interactive video training (Behavioral)
结局指标
主要结局
The Comprehensive Diabetes Self-Management Scale (CDSMS)
时间窗: Baseline (prior to intervention) and at 3-month follow-up
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.
Hba1c
时间窗: Baseline (prior to intervention) and at 3-month follow-up
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.
Diabetes Empowerment Scale (DES)
时间窗: Baseline (prior to intervention) and at 3-month follow-up
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.
Estimated average glucose (ADAG)
时间窗: Baseline (prior to intervention) and at 3-month follow-up
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.
Fasting plasma glucose (FPG)
时间窗: Baseline (prior to intervention) and at 3-month follow-up
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.
次要结局
- SF-12 Health Survey (Secondary Outcome)(Baseline (prior to intervention) and at 3-month follow-up)
研究者
Saadet Can Çiçek
Associate professor
Abant Izzet Baysal University