Patient Engagement in Using the Technology for Self-Tracking Medication Safety Events
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Number of emergency room visits
研究概览
简要总结
This clinical trial evaluates the usefulness of a self-monitoring platform for tracking medication safety events and concerns in patients with lung, colorectal, breast, and prostate cancer. Patients receiving oral anticancer agents often encounter challenges in managing complex treatment regimens, potentially life-threatening toxicities, and drug-drug and drug-food interactions at home. To achieve the goal of medication safety, they need to become "vigilant partners" in medication and toxicity self-monitoring, including timely reporting of medication events to clinicians when their care transitions back home. In this study, patients use an online self-monitoring platform to track their experiences or concerns about taking their medications, including their experiences with symptoms. This platform may be a useful way for patients to track problems they have when taking their medications at home and may help them take better care of their health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
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
- •Participants are adult patients (aged 18 years or older)
- •Diagnosed with lung, colorectal, breast, or prostate cancer
- •Are currently receiving active cancer treatments
- •Are self-managing one or more prescribed cancer medications
- •Participants must have access to technology devices (smartphone, tablet, computer) to track their experiences or concerns about medication safety events, or their family members can help them access technology devices to track the events or concerns
- •Speaks and reads English or has a support person (family member or friend) who can assist
排除标准
- •Can't access technology or do not use technology
- •Do not have access to the internet
- •Do not speak or read English
- •Not permitted to participate by their health care providers
结局指标
主要结局
Number of emergency room visits
时间窗: Up to 12 months
Will be measured by both self-report and chart review. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.
Self-reported system usability
时间窗: Up to 6 months
Self-reported system usability will be assessed using the 10-item System Usability Scale. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.
Perceived usefulness
时间窗: Up to 6 months
Qualitative data, including brief interview data will be analyzed and summarized through content analysis.
Ease of use
时间窗: Up to 6 months
Qualitative data, including brief interview data will be analyzed and summarized through content analysis.
Attitudes toward use
时间窗: Up to 6 months
Qualitative data, including brief interview data will be analyzed and summarized through content analysis.
Intention to use and continuous use of the system over time
时间窗: Up to 12 months
Qualitative data, including brief interview data will be analyzed and summarized through content analysis.
Self-reported patient engagement
时间窗: Up to 6 months
Self-reported patient engagement will be measured by the 9-item Twente Engagement with Ehealth Technologies Scale (TWEETS), including three dimensions, behavioral engagement, cognitive engagement, and affective engagement. Will use the overall TWEETS score to evaluate patient engagement in this study, rather than analyzing each dimension separately. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables. Will use repeated measures analysis of variance to assess the changes in mean scores of patient engagement. Univariate associations between baseline personal and clinical factors and patient engagement at each time point will be assessed using correlation analyses (Pearson or Spearman), Chi-square tests, or non-parametric Mann-Whitney U tests, depending on the variable types. Multiple linear regressions will be conducted to assess associations between patient engagement and outcomes.
System usage over time
时间窗: Up to 12 months
Will be objectively recorded by the system logs and analyzed using Google Analytics (dashboard only), including parameters like the number of logins, number of tab pages clicked, number of events or concerns self-tracked, and more. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.
Patient activation levels
时间窗: Up to 6 months
Patient activation levels will be measured by the Short Form of Patient Activation Measure. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.
Medication self-management ability
时间窗: Up to 6 months
Medication self-management ability will be measured by the Measure of Medication Self-Management. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.
Symptom distress
时间窗: Up to 6 months
Symptom distress will be measured by the 19-item MD Anderson Symptom Inventory. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.
Health related quality of life
时间窗: Up to 6 months
Health-related quality of life will be measured by the 27-item Functional Assessment of Cancer Therapy - General. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.
Number of hospitalizations
时间窗: Up to 12 months
Will be measured by both self-report and chart review. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.
User experiences with the system
时间窗: Up to 6 months
Participants' user experiences with the system, such as perceived facilitators or barrios to system use, along with their suggestions for system improvement, will be collected through a brief individual interview. Qualitative data, including brief interview data will be analyzed and summarized through content analysis.
次要结局
- Self-tracked, structured medication safety events or concerns(Up to 12 months)