Clinical trial NCT04714788: A Mobile App to Improve Participation in Following-up Cohorts
Official title: A Mobile App to Improve Participation in Following-up Cohorts of Individuals Born Preterm: a Pragmatic Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Participants of Longitudinal Cohort Studies
Controls
Keywords: Cohort Studies
Mobile Applications
Data Collection
Lead sponsor: Instituto de Saude Publica da Universidade do Porto
Sponsor class: OTHER
Collaborators: name: Finnish Institute for Health and Welfare
name: Netherlands Organisation for Scientific Research
name: University of Tartu
First posted: 2021-01-19
Enrollment: 310
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Participation
timeFrame: Baseline
Secondary outcomes:
measure: Completion rates
timeFrame: 4- weeks
measure: Usability
timeFrame: 4-weeks
measure: Acceptability
timeFrame: 4- weeks
measure: Hawthorne effect - Physical activity
timeFrame: 1-week
measure: Hawthorne effect - Mood status
timeFrame: 1-week
measure: Agreement of information (mobile app vs. questionnaire on mood status)
timeFrame: 4-weeks
measure: Agreement of information (mobile app vs. questionnaire on physical activity)
timeFrame: 4-weeks
measure: Preference of methods
timeFrame: 4-weeks
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Public Health of the University of Porto (ISPUP)
name: Henrique Barros, Professor
role: PRINCIPAL_INVESTIGATOR
References: