A Mobile App to Improve Participation in Following-up Cohorts

Controls Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Controls
• Participants of Longitudinal Cohort Studies

• NCT number: NCT04714788
• Study type: Interventional
• Source: Instituto de Saude Publica da Universidade do Porto
• Contact: Raquel Teixeira, Master
• Phone: +351 222 061 820
• Email: raquel.teixeira@ispup.up.pt
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2021
• Completion date: April 2021