Effect of mHealth Intervention on Oral Health-Related Quality of Life Among Adult Patients Registered in Specialized Disease Centers in Al-Ahsa, Saudi Arabia: A Quasi-Experimental Pragmatic Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 206
- 试验地点
- 4
- 主要终点
- Change in Total Oral Health Impact Profile-14 (OHIP-14) Score From Baseline to 3 Months
研究概览
简要总结
This study evaluated whether an mHealth oral health education intervention could improve oral health-related quality of life among adults with chronic systemic diseases registered in specialized disease centers in Al-Ahsa, Saudi Arabia. Adults with type 1 diabetes mellitus, cardiovascular disease, chronic kidney disease, or hereditary blood disorders were included.
Participants were assigned to either an intervention group or a control group. Both groups continued to receive routine care. The control group received a standardized printed oral health education leaflet, while the intervention group received an mHealth oral health education program consisting of five educational videos covering toothbrush and fluoride toothpaste selection, toothbrushing technique, dental flossing, tongue cleaning, and water flosser use. The educational materials were delivered electronically through a secure web-based platform, with links sent through WhatsApp at regular intervals during the 3-month intervention period.
Oral health-related quality of life was assessed using the validated Arabic version of the 14-item Oral Health Impact Profile (OHIP-14) at baseline, 1 month, and 3 months. The main hypothesis was that participants receiving the mHealth intervention would show greater improvement in oral health-related quality of life over the 3-month study period compared with participants receiving the control condition.
详细描述
This pragmatic quasi-experimental study was conducted among adult patients registered in four specialized disease centers in Al-Ahsa, Saudi Arabia: the Endocrinology and Diabetes Center, Prince Sultan Center for Cardiac Diseases and Surgery, Al-Jaber Kidney Center, and Hereditary Blood Diseases Center. The study population included adults with type 1 diabetes mellitus, cardiovascular disease, chronic kidney disease, or hereditary blood disorders.
Eligible participants provided electronic informed consent before participation. Following baseline assessment, participants were assigned to parallel intervention and control groups. The intervention lasted 3 months, with assessments conducted at baseline (T0), 1 month (T1), and 3 months (T2).
Participants in both groups continued their routine health care. The control group received a standardized printed oral health education leaflet containing recommendations for daily home oral care. In addition to routine care, the intervention group received five Arabic educational videos addressing toothbrush and fluoride toothpaste selection, toothbrushing technique, dental flossing, tongue cleaning, and water flosser use. The intervention was delivered through a secure web-based platform, and access links were sent through WhatsApp. The educational package was re-sent every 2 weeks during the intervention period to reinforce exposure to the educational content.
Oral health-related quality of life was measured using the validated Arabic version of the 14-item Oral Health Impact Profile (OHIP-14). Assessments were completed at baseline, 1 month, and 3 months. The principal comparison focused on differences between the intervention and control groups in change in total OHIP-14 score from baseline to the 3-month assessment. Additional analyses examined OHIP-14 over the study period and its relationship with selected participant characteristics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older.
- •Registered at one of the participating specialized disease centers in Al-Ahsa, Saudi Arabia.
- •Physician-confirmed diagnosis of type 1 diabetes mellitus, cardiovascular disease, chronic kidney disease, or a hereditary blood disorder.
- •Medically stable at the time of enrollment.
- •Has access to a smartphone and the internet.
- •Able to understand Arabic.
- •Provides electronic informed consent.
- •Willing and able to participate for the 3-month study period.
排除标准
- •Unable to use a smartphone or access the digital intervention.
- •Cognitive or psychiatric impairment that could interfere with participation or completion of study assessments.
- •Severe disability that prevents participation in the study procedures.
- •Completely edentulous.
- •Pregnant at the time of enrollment.
- •Currently enrolled in another oral health intervention study.
- •Planning to relocate during the 3-month study period.
- •Medically unstable or considered unsuitable for participation based on clinical assessment.
研究组 & 干预措施
mHealth Oral Health Education Intervention
Participants received routine care, including the standardized printed oral health education leaflet provided during routine visits, plus a 3-month mHealth oral health education intervention consisting of five Arabic educational videos.
干预措施: mHealth Oral Health Education Intervention (Behavioral)
mHealth Oral Health Education Intervention
Participants received routine care, including the standardized printed oral health education leaflet provided during routine visits, plus a 3-month mHealth oral health education intervention consisting of five Arabic educational videos.
干预措施: Printed Oral Health Education Leaflet (Behavioral)
Control
Participants received routine care, including the standardized printed oral health education leaflet provided during routine visits, but did not receive the mHealth educational videos.
干预措施: Printed Oral Health Education Leaflet (Behavioral)
结局指标
主要结局
Change in Total Oral Health Impact Profile-14 (OHIP-14) Score From Baseline to 3 Months
时间窗: Baseline and 3 months
Oral health-related quality of life was assessed using the validated Arabic version of the 14-item Oral Health Impact Profile (OHIP-14). Each item is scored from 0 to 4, yielding a total score ranging from 0 to 56. Higher scores indicate poorer oral health-related quality of life. The outcome is the change in total OHIP-14 score from baseline to 3 months, compared between the intervention and control groups.
次要结局
- Change in Total Oral Health Impact Profile-14 (OHIP-14) Score From Baseline to 1 Month(Baseline and 1 month)
- Total Oral Health Impact Profile-14 (OHIP-14) Score Trajectory Across the Study Period(Baseline, 1 month, and 3 months)
- Seven Domain Scores of the Oral Health Impact Profile-14 (OHIP-14)(Baseline, 1 month, and 3 months)