Exploring Engagement With Remote Symptom Tracking for Depression (RADAR: Engage)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-07

Study Completion Date

2021-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this study is to understand how best to promote engagement with remote measurement technology (RMT) research in major depressive disorder, using the RADAR-MDD infrastructure as a case study. An adapted questionnaire app with insightful notifications and progress visualization will be compared against the app as usual, in terms of behavioural and experiential engagement.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Remote Evaluation and Alerting for Collaborative Health (REACH) in Depression

NCT07174557

Depression Major Depressive Disorder

NOT_YET_RECRUITING NA

Lifestyle Intervention for Symptoms of Depression wIth App Support in General Practice

NCT07022184

Depressive/Anxiety Symptoms Depressive Disorder

RECRUITING NA

Modeling and Predicting Real World Behavior Using Mobile Sensor Data on Patients With Major Depressive Disorder

NCT02499094

Depressive Disorder

COMPLETED NA

Mobile Sensing and Support for Depression

NCT02776839

Depression

COMPLETED NA

Reward Function and Therapy for Late-Life Depression

NCT03688139

Major Depressive Disorder

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Remote measurement technologies (RMTs) provide an opportunity for real-time, longitudinal health tracking through a combination of smartphone apps for symptom reporting (active RMT; aRMT) and mobile/wearable sensors for passive data collection (passive RMT; pRMT). The use of RMTs to track relapse and remission of symptoms in major depressive disorder (MDD) is thought to be more reflective of patient daily experience, in comparison to retrospective recall during clinic visits. The Remote Assessment of Disease and Relapse- Major Depressive Disorder (RADAR-MDD) study uses RMTs to identify predictors of MDD relapse. It collects multiparametric RMT data through the RADAR-base system over a two year follow-up period; aRMT data is collected via mood-tracking questionnaires in the active app, and pRMT data is collected via a fitness watch, the Fitbit Charge device. The promise of RADAR-MDD depends heavily on user engagement with the app. Currently, engagement with aRMT symptom tracking in the field is hugely heterogeneous and preliminary estimates of the RADAR-MDD study suggest around 50% completion of fortnightly questionnaires. There are several, in-app methods available to promote engagement with mHealth tools. Notifications with theoretically informed content can provide a trigger to perform a behaviour, and data visualisation of progress can prompt continued data input. It is unclear which combination of in-app features can promote engagement with the RADAR-base system, while minimising participant burden.

This study therefore aims to understand how best to promote engagement with RMT research, using the RADAR-MDD project as a case study. This protocol will outline a mixed-methods approach to exploring the impact of additional, in-app components on engagement with symptom tracking via the RADAR-Base infrastructure. First, a two-armed randomized controlled trial will compare the RADAR-MDD questionnaire app as usual with an adapted app with insightful notifications and progress visualization, aimed at promoting behavioural and experiential engagement. Engagement will be measured as a) provision of symptom tracking scores over the 12-week study period, and b) the degree to which participants feel experientially engaged with symptom tracking via the system. Second, qualitative interviews will reveal participant experiences of the techniques used.

The study has three main objectives:

To examine the impact of an adapted smartphone app on behavioural engagement with RMT symptom tracking, in comparison with the RADAR-MDD app as usual;

To examine the impact of an adapted smartphone app on experiential engagement with RMT symptom tracking, in comparison with the RADAR-MDD app as usual;

Qualitatively explore the views of participants on the use of an adapted smartphone app to increase engagement with the RADAR-Base system.

Findings in this field would go some way to providing scalable solutions for engagement in RMT studies, higher quality results and applications for implementation into clinical practice.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Major Depressive Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomised to one of two arms, the app as usual or the adapted app.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Participants are unaware of the changes that have been made to the app, and therefore are unaware of which arm they are randomised to.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

RADAR-MDD Questionnaire App as Usual

The RADAR-MDD questionnaire app as usual asks participants to complete 3x active tasks per week, with one reminder notification at 9am on a day that a questionnaire is due. The notification reads 'Questionnaire Time. Won't usually take longer than 3 minutes'. The participant is not able to view any data progress, aside from through the Fitbit app, which was present in the original RADAR-MDD study.

Group Type NO_INTERVENTION

No interventions assigned to this group

RADAR-MDD Adapted Questionnaire App

The following components are also present:

Notifications: The notification will alternate between the phrases 'Questionnaire Time. Symptom tracking might increase self-awareness of your emotions (Bakker \& Rickard, 2018)', 'Questionnaire Time. Symptom tracking is a technique often used in treatment to increase insight into your symptoms (Kramer et al., 2014)', and 'Questionnaire Time. Tracking your symptoms through a smartphone and Fitbit might help research to better understand health conditions'.

Progress visualisation: Participants will be able to view their questionnaire completion progress as a visualisation through the app, in the form of a graph.

Additional components: An additional text on the home screen of the active app will read 'You can contact your research team between 9am-5pm Mon-Fri if you have questions, [email protected]'.

Group Type EXPERIMENTAL

Smartphone app in-app components

Intervention Type OTHER

Insightful notification text, data visualisation, research team contact details.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Smartphone app in-app components

Insightful notification text, data visualisation, research team contact details.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Participation in the RADAR-MDD London site study
* Consent for future research contact given during participation in the RADAR-MDD study
* Willing and able to continue using an Android smartphone
* Willing and able to continue using a Fitbit device
* Capacity to give informed consent