A Mobile App to Improve Participation in Following-up Cohorts

Instituto de Saude Publica da Universidade do Porto

Status: Unknown

Conditions: Participants of Longitudinal Cohort Studies; Controls

Treatments: Other: Usual data collection methods; Device: RECAP_MyLife mobile app

Study type: Interventional

Funder types: Other

Identifiers

NCT04714788

CE20160

Details and patient eligibility

About

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.

Full 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.

Enrollment: 310 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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310 participants in 2 patient groups

Intervention group RECAP_MyLife mobile app

Experimental group

Description:

Participants in the intervention group will be instructed to use the mobile app daily for four weeks.

Treatment:

Device: RECAP_MyLife mobile app

Control group

Active Comparator group

Description:

Comparator will be the usual data collection method applied by the cohorts.

Treatment:

Other: Usual data collection methods