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Observational Study
. 2022 Feb 21;22(1):136.
doi: 10.1186/s12888-022-03753-1.

Remote Assessment of Disease and Relapse in Major Depressive Disorder (RADAR-MDD): recruitment, retention, and data availability in a longitudinal remote measurement study

Faith Matcham  1 , Daniel Leightley  2 , Sara Siddi  3 , Femke Lamers  4 , Katie M White  2 , Peter Annas  5 , Giovanni de Girolamo  6 , Sonia Difrancesco  4 , Josep Maria Haro  3 , Melany Horsfall  4 , Alina Ivan  2 , Grace Lavelle  2 , Qingqin Li  7 , Federica Lombardini  3 , David C Mohr  8 , Vaibhav A Narayan  7 , Carolin Oetzmann  2 , Brenda W J H Penninx  4 , Stuart Bruce  9 , Raluca Nica  9 , Sara K Simblett  2 , Til Wykes  2 , Jens Christian Brasen  5 , Inez Myin-Germeys  10 , Aki Rintala  10   11 , Pauline Conde  12 , Richard J B Dobson  12 , Amos A Folarin  12 , Callum Stewart  12 , Yatharth Ranjan  12 , Zulqarnain Rashid  12 , Nick Cummins  12   13 , Nikolay V Manyakov  14 , Srinivasan Vairavan  7 , Matthew Hotopf  2   15 ; RADAR-CNS consortium
Affiliations
Observational Study

Remote Assessment of Disease and Relapse in Major Depressive Disorder (RADAR-MDD): recruitment, retention, and data availability in a longitudinal remote measurement study

Faith Matcham et al. BMC Psychiatry. .

Abstract

Background: Major Depressive Disorder (MDD) is prevalent, often chronic, and requires ongoing monitoring of symptoms to track response to treatment and identify early indicators of relapse. Remote Measurement Technologies (RMT) provide an opportunity to transform the measurement and management of MDD, via data collected from inbuilt smartphone sensors and wearable devices alongside app-based questionnaires and tasks. A key question for the field is the extent to which participants can adhere to research protocols and the completeness of data collected. We aimed to describe drop out and data completeness in a naturalistic multimodal longitudinal RMT study, in people with a history of recurrent MDD. We further aimed to determine whether those experiencing a depressive relapse at baseline contributed less complete data.

Methods: Remote Assessment of Disease and Relapse - Major Depressive Disorder (RADAR-MDD) is a multi-centre, prospective observational cohort study conducted as part of the Remote Assessment of Disease and Relapse - Central Nervous System (RADAR-CNS) program. People with a history of MDD were provided with a wrist-worn wearable device, and smartphone apps designed to: a) collect data from smartphone sensors; and b) deliver questionnaires, speech tasks, and cognitive assessments. Participants were followed-up for a minimum of 11 months and maximum of 24 months.

Results: Individuals with a history of MDD (n = 623) were enrolled in the study,. We report 80% completion rates for primary outcome assessments across all follow-up timepoints. 79.8% of people participated for the maximum amount of time available and 20.2% withdrew prematurely. We found no evidence of an association between the severity of depression symptoms at baseline and the availability of data. In total, 110 participants had > 50% data available across all data types.

Conclusions: RADAR-MDD is the largest multimodal RMT study in the field of mental health. Here, we have shown that collecting RMT data from a clinical population is feasible. We found comparable levels of data availability in active and passive forms of data collection, demonstrating that both are feasible in this patient group.

Keywords: Cohort study; Longitudinal; Major depressive disorder; Multicentre; Remote measurement technologies.

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Conflict of interest statement

JCB and PA are full-time employees of H. Lundbeck A/S. DCM has accepted honoraria and consulting fees from Apple, Inc., Otsuka Pharmaceuticals, Pear Therapeutics, and the One Mind Foundation, royalties from Oxford Press, and has an ownership interest in Adaptive Health, Inc. NVM is an employee of Janssen Pharmaceutica NV and may hold company equity.

QL, NM, SV and VN are employees of Janssen Research & Development, LLC and hold company stocks/stock options. JMH has received economic compensation for participating in advisory boards or giving educational lectures from Eli Lilly & Co, Sanofi, Lundbeck, and Otsuka. No other authors have competing interests to declare.

Figures

Fig. 1
Fig. 1
STROBE flowchart for recruitment into RADAR-MDD
Fig. 2
Fig. 2
Participants “not contacted” because they had already completed the maximum amount of follow-up time or had already withdrawn from the study. Participants were “contacted” when they were still active participants. *Reasons for withdrawal provided in Supplementary file 4. **Invalid outcomes collected ±21 days of due date
Fig. 3
Fig. 3
Questionnaires triggered every 2 weeks; maximum number of possible responses: 52. 3a: 8-item Patient Health Questionnaire (PHQ8); 3b: Rosenberg Self-Esteem Scale (RSES); 3c: Speech data
Fig. 4
Fig. 4
Questionnaires triggered every 6 weeks; maximum number of possible responses: 17. 4a: 5-item Perceived Deficits Questionnaire (PDQ5); 4b: Code Breaker; 4c: Spotter; 4d: Symbol Check; 4e: Trails
Fig. 5
Fig. 5
A) Heatmap representing study day and data points per hour. B) percentage wear time stratified by baseline depression status
See this image and copyright information in PMC

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