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临床试验/NCT02088333
NCT02088333已完成不适用

A Primary Care Multilevel mHealth Colorectal Cancer Screening (mCRC) Intervention

Wake Forest University Health Sciences12 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2014年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
450
试验地点
12
主要终点
Completion of CRC Screening

研究概览

简要总结

The purpose of this study is to determine whether a multilevel mHealth intervention (mCRC) can increase the percentage of patients who receive colorectal cancer screening. The mCRC intervention will include a tablet-based patient education program, clinic protocols to facilitate the ordering of CRC screening tests, and electronic messaging with patients to promote screening. The investigators hypothesize that participants randomized to mCRC will be more likely to complete screening compared with those randomized to the control arm of the study. Additionally, the investigators hypothesize mCRC will increase several intermediate outcomes (such as knowledge, attitudes, beliefs, and test ordering) which will predict completion of screening. Lastly, the investigators hypothesize the mCRC intervention will add little to the overall cost of screening.

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 (Investigator)

入排标准

年龄范围
50 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • English-speaking patients aged 50 - 74 years
  • Scheduled to see a primary care provider for a routine (i.e., non-urgent care) visit
  • Due for colorectal cancer screening

排除标准

  • A personal history of CRC
  • Specific CRC risk factors, including: First degree relative with CRC; Personal history of adenomatous polyps; Recent blood in stools
  • Obvious physical or mental disability that would prevent participant from interacting with a tablet device.
  • Receipt of treatment for cancer (excluding non-melanoma skin cancers) within the last 6 months.

结局指标

主要结局

Completion of CRC Screening

时间窗: 24 weeks

Patient completion of a colorectal cancer screening test, such as the fecal occult blood test, a flexible sigmoidoscopy, or a colonoscopy.

次要结局

  • Ability to make a screening decision(Day of enrollment)
  • Self-efficacy(Day of enrollment)
  • Cost of the mCRC intervention(24 weeks)
  • CRC Screening Attitudes and Beliefs(Day of enrollment)
  • Intention to receive CRC screening(Day of enrollment)
  • Satisfaction with screening decision(Up to 5 days)
  • CRC screening test order(24 weeks)
  • CRC screening discussions(Up to 5 days)
  • Usability of the mCRC system(Day of enrollment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (12)

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