A Mobile App to Improve Participation in Following-up Cohorts of Individuals Born Preterm: a Pragmatic Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 310
- 主要终点
- Participation
研究概览
简要总结
The main objective is to test the superiority of a newly developed mobile application - RECAP_MyLife - for data collection in cohort studies in order to increase participation in follow-up evaluations. We hypothesize that data collection through a mobile app will contribute to improvements in participation.
An accurate assessment of the potential benefits and drawbacks of using this mobile technology tool for data collection in cohort studies will be conducted. For such, the study will be conducted in three cohorts developed in different temporal, cultural, and geographic contexts, increasing the generalization of the results found. This evaluation is intended to contribute to the development of more appropriate tools for data collection and consequently to increase participation in epidemiological studies.
详细描述
This is a multicenter, two-arm, parallel unmasked pragmatic randomized controlled trial with baseline and post-intervention (4 weeks from baseline) assessments. A convenience sample of participants of three population-based cohorts of individuals born very preterm and/or very low birth weight will be randomized and allocated 1:1 to either a mobile app intervention group or into the control arm (usual data collection methods).
Secondary aims of this study are:
- To evaluate the usability and acceptability of the mobile app among cohort participants.
- To investigate the potential Hawthorne effect on the results on physical activity behavior and mood status.
- To measure the agreement between passively tracked physical activity by the mobile app and physical activity measured weekly with a self-reported questionnaire.
- To measure the agreement between mood status collected by the mobile app through Ecological Momentary Assessment and mood status measured weekly with a self-reported questionnaire.
- To survey participant's preferences about the different data collection methods.
Intention-to-treat approach will be applied in the data analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals aged 16 years or over
- •Individuals with no evidence of visual impairment, physical condition that may affect the ability to walk, or major cognitive or motor disabilities until the enrollment of the study
- •Individuals owning a smartphone with an Android software version 7 or newer.
排除标准
- 未提供
研究组 & 干预措施
Intervention group RECAP_MyLife mobile app
Participants in the intervention group will be instructed to use the mobile app daily for four weeks.
干预措施: RECAP_MyLife mobile app (Device)
Control group
Comparator will be the usual data collection method applied by the cohorts.
干预措施: Usual data collection methods (Other)
结局指标
主要结局
Participation
时间窗: Baseline
Defined as the total number of individuals who give consent to participate divided by the number of eligible individuals invited for the study.
次要结局
- Acceptability(4- weeks)
- Hawthorne effect - Mood status(1-week)
- Completion rates(4- weeks)
- Usability(4-weeks)
- Agreement of information (mobile app vs. questionnaire on mood status)(4-weeks)
- Hawthorne effect - Physical activity(1-week)
- Agreement of information (mobile app vs. questionnaire on physical activity)(4-weeks)
- Preference of methods(4-weeks)