Cost-Effectiveness and Implementation of Integrated Diabetes-Oral Health Care in Oman: A Health Belief Model-Based Intervention to Enhance Clinical, Behavioral, and Exploratory Oral Microbiome in Health System Outcomes in Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 290
- 主要终点
- Change in Glycated Hemoglobin (HbA1c) From Baseline to 12 Months
研究概览
简要总结
Type 2 diabetes mellitus (T2DM) and periodontal (gum) disease are closely related conditions that may negatively affect each other. However, oral health is not routinely integrated into diabetes self-management education. This study will evaluate whether a structured diabetes-oral health educational intervention based on the Health Belief Model can improve glycaemic control, periodontal health, self-management behaviours, and quality of life among adults with T2DM in Oman.
This multicentre randomized controlled trial will include 290 adults with T2DM. Participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive six individual, structured diabetes-oral health education sessions over 12 weeks in addition to usual care. The control group will continue to receive standard diabetes care and education.
Participants will be followed for 12 months. The primary outcome is change in glycated haemoglobin (HbA1c) from baseline to 12 months. Secondary outcomes include periodontal health, diabetes and oral-health self-care behaviours, Health Belief Model constructs, quality of life, psychological well-being, diabetes distress, healthcare utilization, and healthcare costs. The study will also assess the cost-effectiveness of the intervention. Exploratory components will assess previously undiagnosed periodontal disease and examine associations between periodontal changes and the oral microbiome.
详细描述
Type 2 diabetes mellitus (T2DM) is an important public health problem in Oman. Periodontal disease is common among people with diabetes, and the relationship between diabetes and periodontal disease is bidirectional. Poor glycaemic control may contribute to periodontal inflammation, while periodontal inflammation may adversely affect metabolic control. Despite this relationship, diabetes education commonly focuses on glycaemic control and general diabetes self-management, with limited structured integration of oral-health education and behavioural approaches.
This study is a multicentre, two-arm randomized controlled trial designed to evaluate the effectiveness and cost-effectiveness of an integrated diabetes-oral health educational intervention based on the Health Belief Model (HBM). The study will recruit 290 adults with T2DM (145 participants per group) from participating diabetes clinics in Oman. Participants will be allocated to either the intervention group or the control group.
Participants assigned to the intervention group will receive six structured, individual HBM-based educational sessions, approximately 30 minutes each, delivered over 12 weeks. The intervention addresses diabetes and oral-health risk awareness; the severity and consequences of periodontal disease in people with T2DM; benefits of glycaemic control and oral hygiene; barriers to oral-health self-care and practical solutions; toothbrushing, interdental cleaning, and self-monitoring skills; and maintenance planning and relapse prevention. Sessions will include structured educational material, individualized advice, and goal-setting. Participants in the control group will continue to receive standard diabetes care and education.
Data will be collected at baseline and at 3, 6, and 12 months, as appropriate for each outcome. The primary outcome is change in HbA1c from baseline to 12 months. Secondary outcomes include periodontal clinical indicators, diabetes and oral-health self-management behaviours, HBM constructs, oral health-related and general health-related quality of life, psychological well-being, diabetes distress, healthcare utilization, and direct medical costs. An economic evaluation will assess the cost-effectiveness of the intervention.
As an exploratory component, participants will undergo periodontal assessment to estimate the prevalence of previously undiagnosed periodontal disease and examine its association with glycaemic control. The study will also explore associations between changes in periodontal status and oral microbiome profiles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 35 years or older.
- •Confirmed diagnosis of type 2 diabetes mellitus (T2DM), documented in the medical record for at least 12 months.
- •Able to understand Arabic or English.
- •Able to provide written informed consent.
- •Able to attend the scheduled educational sessions and follow-up visits.
排除标准
- •Pregnant or breastfeeding.
- •Cognitive impairment or severe mental illness limiting participation.
- •Active systemic infectious diseases such as tuberculosis, syphilis, or HIV.
- •Use of medications that may significantly affect glucose metabolism or gingival health, such as long-term systemic corticosteroids, immunosuppressants, phenytoin, or calcium channel blockers.
- •Severe periodontitis requiring immediate surgical intervention.
- •Participation in another diabetes or oral health intervention trial.
- •Unable to comply with the follow-up schedule.
研究组 & 干预措施
Health Belief Model-Based Educational Intervention
Participants allocated to this arm will receive an individualized Health Belief Model-based integrated diabetes-oral health educational programme in addition to routine diabetes care. The intervention consists of six individual face-to-face educational sessions delivered over 12 weeks, with each session lasting approximately 30 minutes. The programme addresses diabetes and oral health risk awareness, periodontal disease, benefits of glycaemic control and oral hygiene, barriers to oral health self-care, practical self-care skills, goal-setting, and maintenance planning.
干预措施: Health Belief Model-Based Integrated Diabetes-Oral Health Educational Intervention (Behavioral)
Standard Diabetes Education and Routine Care
Participants allocated to this arm will continue to receive standard diabetes education and routine clinical care. This includes routine advice on diet, medication adherence, physical activity, and blood glucose monitoring. Participants in this arm will not receive the structured Health Belief Model-based integrated diabetes-oral health educational intervention.
干预措施: Standard Diabetes Education and Routine Care (Behavioral)
结局指标
主要结局
Change in Glycated Hemoglobin (HbA1c) From Baseline to 12 Months
时间窗: Baseline to 12 months
Change in HbA1c (%) from baseline to 12 months will be used to assess the effect of the intervention on glycaemic control. HbA1c will be measured using blood samples processed in a certified hospital laboratory. The between-group difference in change over time will be evaluated.
次要结局
- Change in Probing Pocket Depth (PPD)(Baseline, 3 months, 6 months, and 12 months)
- Change in Diabetes Self-Management Behaviors(Baseline, 3 months, 6 months, and 12 months)
- Healthcare Utilization(From baseline through 12 months)
- Change in Oral Health-Related Quality of Life Assessed Using the Oral Health Impact Profile-14 (OHIP-14)(Baseline, 3 months, 6 months, and 12 months)
- Direct Medical Costs(Baseline through 12 months)