NCT04714788

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
310

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 19, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

January 19, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

January 8, 2021

Last Update Submit

January 15, 2021

Conditions

Keywords

Cohort StudiesMobile ApplicationsData Collection

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Completion rates

    4- weeks

  • Usability

    4-weeks

  • Acceptability

    4- weeks

  • Hawthorne effect - Physical activity

    1-week

  • Hawthorne effect - Mood status

    1-week

  • +3 more secondary outcomes

Study Arms (2)

Intervention group RECAP_MyLife mobile app

EXPERIMENTAL

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

Device: RECAP_MyLife mobile app

Control group

ACTIVE COMPARATOR

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

Other: Usual data collection methods

Interventions

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.

Intervention group RECAP_MyLife mobile app

Participants in this group will provide data through usual types of data collection methods (face-to-face assessments, mailed questionnaires, online questionnaires).

Control group

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Henrique Barros, Professor

    Institute of Public Health of the University of Porto (ISPUP)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Raquel Teixeira, Master

CONTACT

Julia Doetsch, Master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2021

First Posted

January 19, 2021

Study Start

February 1, 2021

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

January 19, 2021

Record last verified: 2021-01