Integrated Diabetes and Oral Health Care in Oman
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
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.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
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.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前：Dr Fatma Sultan Al Maskari, Master, and 1st year Phd
- 電話番号：95764646
- メール：s156958@student.squ.edu.om
参加基準
適格基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：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.
|
Participants will receive an individualized Health Belief Model-based integrated diabetes-oral health educational intervention 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 sessions address diabetes and oral health risk awareness, severity and consequences of periodontal disease, benefits of glycaemic control and oral hygiene, barriers to oral health self-care and practical solutions, brushing and interdental cleaning and self-monitoring skills, and maintenance planning and relapse prevention.
Each session includes structured educational material, individualized advice, and simple goal-setting.
|
|
アクティブコンパレータ：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.
|
Participants will receive standard diabetes education and routine clinical care provided by existing diabetes services.
Routine education includes advice on diet, medication adherence, physical activity, and blood glucose monitoring.
Participants will not receive the structured Health Belief Model-based integrated diabetes-oral health educational intervention.
|
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Glycated Hemoglobin (HbA1c) From Baseline to 12 Months
時間枠：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.
|
Baseline to 12 months
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Probing Pocket Depth (PPD)
時間枠：Baseline, 3 months, 6 months, and 12 months
|
Probing pocket depth will be measured in millimeters (mm) using a periodontal probe at six sites per tooth.
Mean probing pocket depth will be calculated for each participant.
Change in mean probing pocket depth from baseline will be compared between the intervention and control groups.
Lower values indicate better periodontal health.
|
Baseline, 3 months, 6 months, and 12 months
|
|
Change in Diabetes Self-Management Behaviors
時間枠：Baseline, 3 months, 6 months, and 12 months
|
Diabetes self-management behaviors will be assessed using the Summary of Diabetes Self-Care Activities (SDSCA) questionnaire.
The SDSCA assesses the frequency of diabetes self-care activities over the previous 7 days.
Items are scored from 0 to 7 days, with higher scores indicating more frequent performance of the assessed self-care behavior.
Change in SDSCA scores from baseline will be compared between the intervention and control groups.
|
Baseline, 3 months, 6 months, and 12 months
|
|
Healthcare Utilization
時間枠：From baseline through 12 months
|
Healthcare utilization will be assessed as the number of healthcare services used by each participant during the study period, including relevant outpatient visits and other healthcare contacts recorded as part of the study.
Healthcare utilization will be compared between the intervention and control groups.
Higher values indicate greater healthcare resource utilization.
|
From baseline through 12 months
|
|
Change in Oral Health-Related Quality of Life Assessed Using the Oral Health Impact Profile-14 (OHIP-14)
時間枠：Baseline, 3 months, 6 months, and 12 months
|
Oral health-related quality of life will be assessed using the 14-item Oral Health Impact Profile (OHIP-14).
Each item is scored from 0 (never) to 4 (very often), producing a total score ranging from 0 to 56.
Higher total scores indicate poorer oral health-related quality of life.
The change in total OHIP-14 score from baseline will be compared between the intervention and control groups.
|
Baseline, 3 months, 6 months, and 12 months
|
|
Direct Medical Costs
時間枠：Baseline through 12 months
|
Direct medical costs associated with healthcare utilization will be estimated from the health-system perspective and reported in Omani Rial (OMR) per participant.
Mean direct medical costs over the study period will be compared between the intervention and control groups.
Higher values indicate greater healthcare costs.
|
Baseline through 12 months
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
その他の研究ID番号
- MoH/CSR/26/32411
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。