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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04714788
• Other study ID #: CE20160
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2021
• Est. completion date: April 2021

Study information

• Verified date: January 2021
• Source: Instituto de Saude Publica da Universidade do Porto
• Contact: Raquel Teixeira, Master
• Phone: +351 222 061 820
• Email: raquel.teixeira[@]ispup.up.pt
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 310
• Est. completion date: April 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Controls
• Participants of Longitudinal Cohort Studies

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Instituto de Saude Publica da Universidade do Porto	Finnish Institute for Health and Welfare, Netherlands Organisation for Scientific Research, University of Tartu

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participation	Defined as the total number of individuals who give consent to participate divided by the number of eligible individuals invited for the study.	Baseline
Secondary	Completion rates	Defined as the total number of participants who complete the follow-up evaluation divided by the number of participants who initiated the trial.	4- weeks
Secondary	Usability	System Usability Scale (SUS)	4-weeks
Secondary	Acceptability	Post-intervention questionnaire	4- weeks
Secondary	Hawthorne effect - Physical activity	It will be measure if the data collection method affects physical activity, by comparing physical activity behavior (IPAQ-S) at baseline with results collected over the study period.	1-week
Secondary	Hawthorne effect - Mood status	It will be measure if the data collection method affects mood status, by comparing mood status at baseline with results collected over the study period ("Circumplex Mood Model" scale).	1-week
Secondary	Agreement of information (mobile app vs. questionnaire on mood status)	It will be assessed in the intervention arm, by comparing the results obtained from the mobile app with those obtained from the self-reported data collected by the "Circumplex Mood Model" scale.	4-weeks
Secondary	Agreement of information (mobile app vs. questionnaire on physical activity)	It will be assessed in the intervention arm, by comparing the results obtained from the mobile app with those obtained from the self-reported data collected by IPAQ-S questionnaire.	4-weeks
Secondary	Preference of methods	Participants of both arms will answer the following question: "If you could choose to participate through an app that measures your movements and asks you to fill in your emotions daily, or through short weekly online/mailed questionnaires, what would you choose? Why?"	4-weeks