ADHD Remote Technology Study of Cardiometabolic Risk Factors and Medication Adherence

NCT05301673 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2024-12-16

No results posted yet for this study

Summary

Attention-deficit/hyperactivity disorder (ADHD) is a common psychiatric disorder, with a prevalence among adults of 2.5%. The disorder is diagnosed based on impairing levels of inattentive, hyperactive and impulsive behaviours. Most adults with ADHD present with additional mental health problems. Adults with ADHD have an increased risk to develop so-called cardiometabolic illnesses, such as type-2 diabetes, obesity and cardiovascular disease (e.g., heart failure). However, detailed knowledge about the screening, diagnosis and management of adults with ADHD and co-occurring cardiometabolic illnesses is lacking. The purpose of ART-CARMA is to (1) obtain real-world data from adults with ADHD daily life on the extent to which ADHD medication treatment and physical activity, individually and jointly, may influence cardiometabolic risks in adults with ADHD, and (2) obtain real-world data of patterns of taking ADHD medication and reasons for not taking medication, over a remote monitoring period of 12 months.

ART-CARMA benefits from the ADHD Remote Technology ('ART') assessment and monitoring system for adults with ADHD (developed by Kuntsi, Dobson, et al.), and the RADAR-base mobile-health platform to which it is linked (developed by Dobson et al; http://www.radar-base.org). ART consists of both active (e.g., questionnaires) and passive (smartphone and a wearable device) monitoring. ART-CARMA will use remote measurement technology (RMT) in adults with ADHD to carry out unobtrusive, real-time data collection over a continuous period of 12 months. By recruiting 300 adults from adult ADHD clinic waiting lists (and a partner/family member/close friend for each of them) and monitoring them remotely, we will obtain objectively measured data relevant to cardiometabolic risk profiles from their daily lives. By targeting the period before starting any ADHD medication through to starting treatment and the subsequent period, up to 12 months in total, we obtain real-time data on multiple parameters, including side effects, that can inform the personalisation of treatment.

Conditions

Sponsors & Collaborators

  • South London and Maudsley NHS Foundation Trust

    collaborator OTHER
  • Barnet, Enfield and Haringey Mental Health NHS Trust

    collaborator OTHER_GOV
  • Hospital Universitari Vall d'Hebron Research Institute

    collaborator OTHER
  • Empatica, Inc.

    collaborator INDUSTRY
  • Örebro University, Sweden

    collaborator OTHER
  • Concentris research management gmbh

    collaborator UNKNOWN
  • Attention Deficit Disorder Information and Support Service

    collaborator UNKNOWN
  • The European Association for the Study of Obesity

    collaborator UNKNOWN
  • Northumberland, Tyne and Wear NHS Foundation Trust

    collaborator OTHER
  • Tees, Esk and Wear Valleys NHS Foundation Trust

    collaborator UNKNOWN
  • South West London and St George's Mental Health NHS Trust

    collaborator OTHER
  • East London NHS Foundation Trust

    collaborator OTHER_GOV
  • Avon and Wiltshire Mental Health Partnership NHS Trust

    collaborator OTHER_GOV
  • King's College London

    lead OTHER

Principal Investigators

  • Jonna Kuntsi, BSc, MSc, PhD · Social, Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-12
Primary Completion
2025-03-31
Completion
2025-03-31

Countries

  • Spain
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05301673 on ClinicalTrials.gov