Internet-Based Motivational Interviewing for Colonoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Number of Participants Who Completed a Screening Colonoscopy
研究概览
简要总结
Compared to other racial groups, African Americans have the highest colorectal cancer (CRC) morbidity and mortality rates. Although colonoscopies can prevent CRC, nearly one third of African Americans have not received a screening colonoscopy within the recommended time frame (one colonoscopy per ten years). It is critical to increase African Americans' screening colonoscopy rates in order to reduce racial inequities in CRC morbidity and mortality. Previous research suggests that a motivational interviewing based intervention may help improve screening colonoscopy uptake. This study will conduct a randomized clinical trial examining the efficacy of a motivational interviewing informed tablet app, called e-Motivate, to improve African Americans' screening colonoscopy uptake. Participants will be African Americans who receive a referral for a screening colonoscopy. Participants (N=200) will be randomly assigned to one of two groups: (1) usual care group (N=100); or (2) e-Motivate app group (N=100). Participants in the usual care group will receive standard clinical care which includes patient navigation (e.g., scheduling, reminder calls). Participants in the e-Motivate group will complete the e-Motivate app in the clinic immediately after they receive a referral for the screening colonoscopy. The participants in the e-Motivate app group will also receive usual care. Six months following the initial referral, participants' medical charts will be reviewed to determine whether the participants completed the recommended screening colonoscopy. Secondary outcomes (e.g., bowel prep quality, number of cancellations) will also be analyzed.
详细描述
Colorectal cancer (CRC), a largely preventable disease, remains the third leading cause of cancer death in the United States. Compared to other racial groups, African Americans have the highest CRC morbidity and mortality rates. Recent reports have found that African Americans' CRC incidence rates are 20% higher and mortality rates are 45% higher than those of whites. Given these disparities, it is critical to increase African Americans' participation in CRC screenings. Of the recommended CRC screening mechanisms, a colonoscopy is often the preferred method because it allows for both the detection and removal of precancerous and cancerous polyps. Although screening colonoscopies can detect and prevent CRC, more than 1/3 of African Americans have not received a screening colonoscopy within the recommended time frame (one screening colonoscopy per ten years). It is critical to increase African Americans' screening colonoscopy rates in order to reduce racial inequities in CRC morbidity and mortality.
A motivational interviewing (MI) intervention can help improve African Americans' screening colonoscopy uptake. MI is a brief patient-centered intervention that increases perceived competence, autonomy, and relatedness in order to promote behavioral change. Extensive research supports the efficacy of MI to promote preventive health screening uptake, including increasing screening colonoscopy rates, and MI has proven efficacious with African Americans across a wide range of diseases.
Traditionally, MI is delivered live, where individuals meet with a professional for a one-on-one intervention. Although efficacious, live-MI is not without limitations. Of greatest concern, live-MI requires both staffing and economic resources, limiting its ability to be widely disseminated. A digital intervention, such a tablet app, may overcome these limitations. By eliminating the need for an on-site professional, a tablet app is a high reach, low cost intervention with the potential to have a significant public health impact.
The primary goal of this study is to conduct a randomized clinical trial (RCT) that examines the efficacy of a tablet app, called e-Motivate, to improve screening colonoscopy rates in African Americans.
The app first underwent iterative field-testing and subsequent modifications to ensure that the app had high usability and acceptability ratings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcome assessor will be blinded to the participants' assigned study group.
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •self-identified as African American/Black
- •received a referral for a screening colonoscopy
- •recommended age to begin screening for colorectal cancer (based on current guidelines)
- •English speaking
排除标准
- •hearing or vision impaired
- •participated in the previous iterative field testing
研究组 & 干预措施
E-Motivate group
Participants complete a 20-minute tablet app, called e-Motivate, and receive usual care.
干预措施: E-Motivate group (Behavioral)
Usual Care Group
Participants in the usual care group will receive standard clinical care for patients referred for a screening colonoscopy
干预措施: Usual Care Group (Behavioral)
结局指标
主要结局
Number of Participants Who Completed a Screening Colonoscopy
时间窗: six months after the initial referral
Six months following the initial referral, medical charts was reviewed to determine whether the participant completed the recommended screening colonoscopy
次要结局
- Number of Participants With Adequate Bowel Prep Quality(six months after initial referral)
- Number of Patients Who Had Rescheduled Appointments(six months)
- Number of Participants Who Were No-show Appointments(six months)
- Number of Participants Who Had Canceled Appointments(six months)
研究者
Sarah Miller
Assistant Professor
Icahn School of Medicine at Mount Sinai