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

King's College London

Status: Active, not recruiting

Conditions: Medication Adherence; Attention Deficit Hyperactivity Disorder; Cardiovascular Diseases

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05301673

304278

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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)

Trial design

600 participants in 2 patient groups

Adults with ADHD

Partner, family member or close friend of the individuals with ADHD