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Active, Not Recruiting

NCT Number: NCT05301673

ADHD Remote Technology Study of Cardiometabolic Risk Factors and Medication Adherence

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Behavior Cardiovascular Diseases Health Behavior Medication Adherence Mental Disorders Neurodevelopmental Disorders Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vall d'Hebron Research Institute, Barcelona, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of DSM-5 ADHD
  • Aged 18-60
  • Able to give informed consent for participation
  • Fluent in English
  • Willing and able to complete self-reported assessments via smartphone
  • Willing to use either their own compatible Android phone or a study Android phone as their only smartphone during the data collection period
  • Willing to wear the wearable device (EmbracePlus) during the data collection period
  • Not on ADHD medication at the time of recruitment

Exclusion criteria

  • Psychosis, currently experiencing a major depressive episode, mania, drug dependence in the last six months, or a major neurological disorder
  • Recent contact with psychiatric acute care (admission, crisis team or liaison team (A&E)) in the last six months
  • Any other major medical disease which might impact upon the patient's ability to participate in normal daily activities (e.g., due to hospitalisations)
  • Pregnancy
  • IQ < 70
  • Does not start ADHD medication following ADHD diagnosis (either due to personal choice or psychiatrist deciding not to prescribe ADHD medication)

Treatment and study plan

Primary outcomes

  1. Change in heart rate

    Time frame: Continuously across a 12-month time period

    EmbracePlus wearable device

  2. Change in blood pressure

    Time frame: Baseline and every 4 weeks up to month 12

    Blood pressure will be measured by participant

  3. Change in weight

    Time frame: Baseline and every 4 weeks up to month 12

    Weight (in kg) will be measured by participant

  4. Change in smoking

    Time frame: Baseline and every 4 weeks up to month 12

    Test Fagerstrom questionnaire. 6-items. Four items are a yes/no questions rated from 0 to 1; and the two remaining were multiple-choice questions rated from 0 to 3 on a 4-point Likert-type scale.

  5. Change in alcohol use

    Time frame: Baseline and every 4 weeks up to month 12

    Alcohol Use Disorders Identification Test (AUDIT) questionnaire. 10-items, 4-point Likert-scale rated from 0 to 3. A score of 8 or more is associated with harmful or hazardous drinking, a score of 13 or more in women, and 15 or more in men, is likely to indicate alcohol dependence.

  6. Change in diet

    Time frame: Baseline and every 4 weeks up to month 12

    14-item Mediterranean diet adherence questionnaire. Each item can be assigned a score of 0 (no adherence to Mediterranean diet) or 1 (adherence). A score of ≤5 is considered low adherence, a score between 6 and 9 is medium adherence, and a score of ≥10 is high adherence.

  7. Change in sleep

    Time frame: Continuously across a 12-month time period

    EmbracePlus wearable device

  8. Change in physiological stress response

    Time frame: Continuously across a 12-month time period

    EmbracePlus wearable device

  9. Change in medication use

    Time frame: Baseline and every day up to month 12

    Non-validated daily medication use questionnaire. 3-items

  10. Adverse side effects

    Time frame: Baseline and every week up to month 12

    Canadian ADHD Resource Alliance. CADDRA Patient ADHD Medication Form. 5-item questionnaires. 3-items record changes in ADHD symptom control, side effects and quality of life using a 7-item Likert-scale, rated from -3 (worse) to 3 (better). 1 item records global changes using a 5-item Likert-scale, rated from 0 (marked deterioration) to 3 (mark improvement). 1 item lists all common side effects of ADHD medication, each side effect is rated from 0 (not at all) to 3 (all the time).

Sponsors and collaborators

Lead sponsor

King's College London

Other

Collaborators

  • Attention Deficit Disorder Information and Support Service
  • Avon and Wiltshire Mental Health Partnership NHS Trust
  • Barnet, Enfield and Haringey Mental Health NHS Trust
  • Concentris research management gmbh
  • East London NHS Foundation Trust
  • Empatica, Inc.
  • Hospital Universitari Vall d'Hebron Research Institute
  • Northumberland, Tyne and Wear NHS Foundation Trust
  • South London and Maudsley NHS Foundation Trust
  • South West London and St George's Mental Health NHS Trust
  • Tees, Esk and Wear Valleys NHS Foundation Trust
  • The European Association for the Study of Obesity
  • Örebro University, Sweden

Registry information

Official study title

ADHD Remote Technology Study of Cardiometabolic Risk Factors and Medication Adherence ('ART-CARMA')

Acronym: ART-CARMA

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 31, 2022
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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