Text Message Intervention to Improve Adherence in Adolescents and Young Adults With Celiac Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Tissue Transglutaminase IgA (TTG IgA)
研究概览
简要总结
This is a prospective randomized controlled trial investigating the impact of educational bidirectional text message reminders on gluten free diet adherence among adolescents and young adults with celiac disease age 12-24. Participants will complete a series of online questionnaires assessing quality of life, patient activation, celiac symptoms, and self reported dietary adherence at the beginning and end of the study. Participants will also have their blood drawn to measure Tissue Transglutaminase IgA (TTG IgA) antibody and Deamidated Gliadin Peptide IgA (DGP IgA) at the beginning and end of the study. Lab draws can be done locally, and are at no cost to the participant. Patients are randomized to the intervention or control group based on enrollment TTG IgA. Intervention group receives 45 unique text messages over the 3 month study. A gift card is provided for participation in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12-24
- •Celiac disease diagnosed by a gastroenterologist at least 1 year prior to enrollment
- •Participant with ability to read email and text messages in English
- •Access to a mobile phone
- •Unlimited text messaging plan or agreement to receive 45 text messages for the study
排除标准
- •Participant inability to answer survey questions and text prompts in English
研究组 & 干预措施
Control (No Text Messages)
Routine care by primary gastroenterologist with no text messages.
Text Message Intervention
A series of 45 unique educational text messages sent over a period of 3 months in the evenings. Text messages include humorous reminders, links to online celiac disease resources, and bidirectional questions.
干预措施: Educational Text Message Reminders (Behavioral)
结局指标
主要结局
Tissue Transglutaminase IgA (TTG IgA)
时间窗: 3 months
Percent change in TTG IgA for each participant pre and post study period
次要结局
- NIH-PROMIS quality of life score(3 months)
- Patient Activation Measure (PAM) score(3 months)
- Patient-reported celiac disease symptom measure (CDI) score(3 months)
- Patient-reported dietary adherence (CDAT) score(3 months)
- Deamidated Gliadin Peptide IgA (DGP IgA)(3 months)
研究者
Kelly Haas
Principle Investigator, Pediatric Gastroenterology Fellow
Stanford University