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Completed
NCT07839429
Effect of mHealth Intervention on Oral Health-Related Quality of Life Among Adult Patients With Chronic Systemic Diseases
Conditions: Type 1 Diabetes Mellitus (T1DM), Cardiovascular Diseases (CVD), Chronic Kidney Disease (Stages 3b-5), Hereditary Blood Disorders
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 206
Sponsor: King Faisal University
Location: Al Jabr Kidney Center Hasa Eastern Province
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Source: ClinicalTrials.gov (NCT07839429). StuddyBuddy aggregates publicly available trial information.