Engagement Study: (Multi-site, Practice-Based Research Network (PBRN) Prospective Clinical Trial to Assess if Knowledge of Genetic Risk Changes Behavior)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- The number of preventive oral health care visits per patient (Dental office visit record review)
研究概览
简要总结
This is a pilot study to determine whether knowledge gained by an individual of genetic risk for severe periodontitis changes the patient's health behavior as measured by an increased frequency of their preventive dental office visits. In addition to the primary objectives of the study, the overall design and logistics will be used to inform a possible future study.
详细描述
Data to be analyzed in this study will be gathered through a patient questionnaire, genetic testing and tracking of preventive dental office visits. Eight hundred (800) total participants will be randomly assigned to either the Usual Care or Experimental Groups. Two hundred participants will be assigned to the Usual Care Group and 600 will be assigned to the Experimental Group. It is anticipated that approximately 17% (~100) of the Experimental Group subjects will refuse to enroll in the study, leaving a final total of approximately 500 subject in this group. Within the Experimental Group, 125 subjects positive for the IL-1 genetic test (PerioPredict® Genetic Risk Test, Interleukin Genetics, Inc., Waltham, MA) will be identified and ~375 will test negative for the IL-1 genetic test.
The Sponsor will enter the subject's dental office registration number into a master spreadsheet and randomly assign every fourth patient to the Usual Care Group and all others will be assigned into the Experimental Group. Information about the study and informed consent will be made available by the dental office for the specific groups, either by directing to a website location with videos and ICFs, or alternatively by by dental office showing informational videos on provided tablet and gathering signed hardcopy ICFs at schedule first visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
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
- •All adult (18 years of age or older) patients from multi-site, practice-based research network dental offices who have dental insurance coverage for preventive care twice per year, but have only used the benefit once per year in the past 2-3 years.
排除标准
- •Patients who previously have had an IL-1 dental genetic test.
- •Patients who have been diagnosed with periodontal disease.
研究组 & 干预措施
Experimental Group
Consented patients who complete the initial Experimental Group Questionnaire, receive a prophylaxis, have the IL-1 genetic test for risk of severe periodontitis performed, their dental records monitored for 18 months post-enrollment, and answer a Study Completion Questionnaire 18 months post-enrollment.
干预措施: IL-1 genetic test for risk of severe periodontitis (Genetic)
Usual Care Group
Consented patients who complete the initial Usual Care Group Questionnaire, receive a prophylaxis and have their dental records monitored for 18 months post-enrollment.
结局指标
主要结局
The number of preventive oral health care visits per patient (Dental office visit record review)
时间窗: 18 months from enrollment
Frequency of preventive oral health care visits within 18 months of enrollment.
次要结局
- Questionnaire on patient demographics and dental healthcare behavior(At enrollment by survey)
- Questionnaire on changes in oral health care behavior and attitudes on genetic testing(18 months after enrollment)