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临床试验/NCT04972474
NCT04972474Unknown不适用

A Two-Armed Trial Exploring the Effects of In-App Components on User Engagement With a Symptom-Tracking System for Depression (RADAR: Engage)

King's College London2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年4月7日最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
2
主要终点
Behavioural engagement

研究概览

简要总结

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.

详细描述

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;

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Development of a comorbid psychiatric disorder since participation in the RADAR-MDD study

结局指标

主要结局

Behavioural engagement

时间窗: Total completion at the 12-week end point

Data completion of active symptom tracking (PHQ-8 scale). Value of 0-12.

次要结局

  • Experiential engagement (2)(Baseline and 12-week point)
  • Experiential engagement (1)(Baseline and 12-week point)
  • System Usability(Baseline and 12-week point)
  • Passive monitoring adherence(Continuously across a 12-week time period)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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