Facilitating Assessment of At-Risk Sailors Using Technology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 279
- 试验地点
- 1
- 主要终点
- Percentage of Cogito Participants Reported Being Satisfied
研究概览
简要总结
Randomized clinical trial with individuals being allocated to experimental (Cogito Companion) or Active Control arms. Those in the latter will receive information regarding widely available mobile self-help apps via a custom mobile app built in MyCAP. This same platform will be used to collect data regarding symptoms. Randomization will be stratified by gender, force (Surface, Aviation), and smartphone model (Android, I-Phone), as Cogito algorithms differ based on smartphone platforms. Participants will be willing Naval personnel being redeployed to CONUS. Data is also being collected (feasibility/acceptability) to inform future implementation..
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)
盲法说明
Outcomes measures will be collected electronically
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Member of the Navel Surface or Aviation Forces;
- •Age: 18-55 years at the time of enrollment;
- •Ability to provide verbal and electronic informed consents;
- •Ownership of smartphone;
- •Willingness to use smartphone and personal data plan to participate.
排除标准
- •Having redeployed (returning to the Continental United States) more than twelve months (approximately) prior to consent.
- •Having an iPhone (until later in 2019 when the Cogito Corporation plans to release the iOS version of the Cogito Companion app).
研究组 & 干预措施
Experimental - Cogito Companion
Those allocated to Experimental arm will have access the Cogito Companion for a three-month period post-consent. Passive data collection will also occur during this period. As a secure, privacy-compliant mobile app, the Cogito Companion facilitates the non-invasive collection, transfer, integration, analysis, and reporting of objective behavioral indicators. The Cogito mobile sensing platform passively gathers behavioral information through an individual's normal smartphone usage. Measurements of location, call, and text patterns are recorded.
干预措施: Experimental - Cogito Companion (Device)
Active Control
Participants randomized to the Active Control group will download MyCAP and have access to resources housed within this app for a three-month period post-consent. Participants will be provided information regarding the mHealth Tool apps, and provided basic information on how to download the apps. As noted above, participants will be provided biweekly surveys .
干预措施: Active Control (Behavioral)
结局指标
主要结局
Percentage of Cogito Participants Reported Being Satisfied
时间窗: From Baseline to Follow-Up, Approximately 3 months
To measure the percentage of participants randomized to Cogito who were satisfied, a 'Client Satisfaction Questionnaire' was distributed to participants to complete and return. Responses were collected and evaluated to find the percentage of participant satisfaction.
次要结局
未报告次要终点
研究者
Lisa Brenner
Investigator
VA Eastern Colorado Health Care System