Controls, Participants of Longitudinal Cohort Studies
Conditions
Keywords
Cohort Studies, Mobile Applications, Data Collection
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.
Interventions
DEVICERECAP_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.
OTHERUsual 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).
Sponsors
Finnish Institute for Health and Welfare
Netherlands Organisation for Scientific Research
University of Tartu
Instituto de Saude Publica da Universidade do Porto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participation | Baseline | Defined as the total number of individuals who give consent to participate divided by the number of eligible individuals invited for the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Usability | 4-weeks | System Usability Scale (SUS) |
| Acceptability | 4- weeks | Post-intervention questionnaire |
| Hawthorne effect - Physical activity | 1-week | 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. |
| Completion rates | 4- weeks | Defined as the total number of participants who complete the follow-up evaluation divided by the number of participants who initiated the trial. |
| Agreement of information (mobile app vs. questionnaire on mood status) | 4-weeks | 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. |
| Agreement of information (mobile app vs. questionnaire on physical activity) | 4-weeks | 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. |
| Preference of methods | 4-weeks | 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? |
| Hawthorne effect - Mood status | 1-week | 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). |
Contacts
Primary ContactRaquel Teixeira, Master
Backup ContactJulia Doetsch, Master
Outcome results
None listed