NCT04714788

A Mobile App to Improve Participation in Following-up Cohorts

A Mobile App to Improve Participation in Following-up Cohorts of Individuals Born Preterm: a Pragmatic Multicenter Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 310 (estimated)
• Sponsor: Instituto de Saude Publica da Universidade do Porto · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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: 1. To evaluate the usability and acceptability of the mobile app among cohort participants. 2. To investigate the potential Hawthorne effect on the results on physical activity behavior and mood status. 3. To measure the agreement between passively tracked physical activity by the mobile app and physical activity measured weekly with a self-reported questionnaire. 4. 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. 5. To survey participant's preferences about the different data collection methods. Intention-to-treat approach will be applied in the data analysis.

Conditions

• Participants of Longitudinal Cohort Studies
• Controls

Interventions

Type	Name	Description
DEVICE	RECAP_MyLife mobile app	The intervention will be the use of a mobile application for collecting data from cohorts participants, envisioning to engage participants and collect continuous unbiased records. Participants in the intervention group will install the mobile application on their smartphones on the beginning of the trial and will be asked to self-report information on mood every day. Simultaneously, physical activity (number of steps) will be passively tracked through real-time information. Participants will complete baseline and post-intervention measures of mood status based on the "Circumplex Mood Model" and IPAQ-Short form. Following these measures, participants will be asked to complete questionnaires on usability (SUS scale) and acceptability of the intervention.
OTHER	Usual data collection methods	Participants in this group will provide data through usual types of data collection methods (face-to-face assessments, mailed questionnaires, online questionnaires).

Timeline

• Start date: 2021-02-01
• Primary completion: 2021-04-01
• Completion: 2021-04-01
• First posted: 2021-01-19
• Last updated: 2021-01-19