Participants of Longitudinal Cohort StudiesNCT04714788
A Mobile App to Improve Participation in Following-up Cohorts
A study testing RECAP_MyLife mobile app and Usual data collection methods in people with Participants of Longitudinal Cohort Studies and Controls, run by Instituto de Saude Publica da Universidade do Porto.
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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Participants of Longitudinal Cohort Studies, Controls
- What is being tested?
- RECAP_MyLife mobile app and Usual data collection methods
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- No sites listed yet
- Study dates
- Feb 2021to Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Mobile App to Improve Participation in Following-up Cohorts of Individuals Born Preterm: a Pragmatic Multicenter Randomized Controlled Trial
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.
Read the 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:
- To evaluate the usability and acceptability of the mobile app among cohort participants.
- To investigate the potential Hawthorne effect on the results on physical activity behavior and mood status.
- To measure the agreement between passively tracked physical activity by the mobile app and physical activity measured weekly with a self-reported questionnaire.
- 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.
- To survey participant's preferences about the different data collection methods.
Intention-to-treat approach will be applied in the data analysis.
- Being tested
- RECAP_MyLife mobile app, Usual data collection methods
- Keywords
- Cohort Studies, Mobile Applications, Data Collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RECAP_MyLife mobile appDevice
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.
Usual data collection methodsOther
Participants in this group will provide data through usual types of data collection methods (face-to-face assessments, mailed questionnaires, online questionnaires).
| Study group | Role | What they receive |
|---|---|---|
| Intervention group RECAP_MyLife mobile app | Experimental | Participants in the intervention group will be instructed to use the mobile app daily for four weeks. Receives: Device: RECAP_MyLife mobile app |
| Control group | Active comparator | Comparator will be the usual data collection method applied by the cohorts. Receives: Other: Usual data collection methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation
Defined as the total number of individuals who give consent to participate divided by the number of eligible individuals invited for the study.
Measured: Baseline
Secondary outcomes (8)
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.
Measured: 4- weeks
Usability
System Usability Scale (SUS)
Measured: 4-weeks
Acceptability
Post-intervention questionnaire
Measured: 4- weeks
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.
Measured: 1-week
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).
Measured: 1-week
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.
Measured: 4-weeks
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.
Measured: 4-weeks
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?"
Measured: 4-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study startFeb 2021 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Participants of Longitudinal Cohort StudiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Saude Publica da Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Finnish Institute for Health and Welfare, Netherlands Organisation for Scientific Research, University of Tartu
- Responsible party
- Sponsor
- Investigators
- Henrique Barros, Professor, Principal investigator, Institute of Public Health of the University of Porto (ISPUP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04714788
- Sponsor's protocol ID
- CE20160
- Status last verified
- Jan 2021
- First submitted
- 8 Jan 2021
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile App to Improve Participation in Following-up Cohorts of Individuals Born Preterm: a Pragmatic Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04714788
- Acronym / sponsor ID
- CE20160
- Keywords
- Cohort Studies, Mobile Applications, Data Collection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Instituto de Saude Publica da Universidade do PortoUniversity, hospital or other
- Collaborators
- Finnish Institute for Health and Welfare, Netherlands Organisation for Scientific Research, University of Tartu
- Study start
- Feb 2021 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 19 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To evaluate the usability and acceptability of the mobile app among cohort participants.
- To investigate the potential Hawthorne effect on the results on physical activity behavior and mood status.
- To measure the agreement between passively tracked physical activity by the mobile app and physical activity measured weekly with a self-reported questionnaire.
- 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.
- To survey participant's preferences about the different data collection methods.
Intention-to-treat approach will be applied in the data analysis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group RECAP_MyLife mobile app | Experimental | Device: RECAP_MyLife mobile appParticipants in the intervention group will be instructed to use the mobile app daily for four weeks. |
| Control group | Active comparator | Other: Usual data collection methodsComparator will be the usual data collection method applied by the cohorts. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RECAP_MyLife mobile appThe 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. | Device | Intervention group RECAP_MyLife mobile app |
| Usual data collection methodsParticipants in this group will provide data through usual types of data collection methods (face-to-face assessments, mailed questionnaires, online questionnaires). | Other | Control group |
Primary outcome
Participation
Time frame: Baseline
Defined as the total number of individuals who give consent to participate divided by the number of eligible individuals invited for the study.
8 secondary outcomes
Completion rates
Time frame: 4- weeks
Usability
Time frame: 4-weeks
Acceptability
Time frame: 4- weeks
Hawthorne effect - Physical activity
Time frame: 1-week
Hawthorne effect - Mood status
Time frame: 1-week
Agreement of information (mobile app vs. questionnaire on mood status)
Time frame: 4-weeks
Agreement of information (mobile app vs. questionnaire on physical activity)
Time frame: 4-weeks
Preference of methods
Time frame: 4-weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henrique Barros, Professor principal investigator
Institute of Public Health of the University of Porto (ISPUP)
Questions about this trial
What is this clinical trial studying?
A study testing RECAP_MyLife mobile app and Usual data collection methods in people with Participants of Longitudinal Cohort Studies and Controls, run by Instituto de Saude Publica da Universidade do Porto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raquel Teixeira, Master (+351 222 061 820, raquel.teixeira@ispup.up.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2021.