Clinical trial NCT05301673: ADHD Remote Technology Study of Cardiometabolic Risk Factors and Medication Adherence
Official title: ADHD Remote Technology Study of Cardiometabolic Risk Factors and Medication Adherence ('ART-CARMA')
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Attention Deficit Hyperactivity Disorder
Cardiovascular Diseases
Medication Adherence
Keywords: ADHD
attention-deficit/hyperactivity disorder
remote measurement technology
mHealth
cardiovascular disease
medication adherence
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: South London and Maudsley NHS Foundation Trust
name: Barnet, Enfield and Haringey Mental Health NHS Trust
name: Hospital Universitari Vall d'Hebron Research Institute
name: Empatica, Inc.
name: Örebro University, Sweden
name: Concentris research management gmbh
name: Attention Deficit Disorder Information and Support Service
name: The European Association for the Study of Obesity
name: Northumberland, Tyne and Wear NHS Foundation Trust
name: Tees, Esk and Wear Valleys NHS Foundation Trust
name: South West London and St George's Mental Health NHS Trust
name: East London NHS Foundation Trust
name: Avon and Wiltshire Mental Health Partnership NHS Trust
First posted: 2022-03-31
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: There are two data collection sites. The KCL site will recruit 150 participants from adult ADHD clinics. The VHIR site will recruit 150 participants from their adult ADHD clinic.

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change in heart rate
timeFrame: Continuously across a 12-month time period
measure: Change in blood pressure
timeFrame: Baseline and every 4 weeks up to month 12
measure: Change in weight
timeFrame: Baseline and every 4 weeks up to month 12
measure: Change in smoking
timeFrame: Baseline and every 4 weeks up to month 12
measure: Change in alcohol use
timeFrame: Baseline and every 4 weeks up to month 12
measure: Change in diet
timeFrame: Baseline and every 4 weeks up to month 12
measure: Change in sleep
timeFrame: Continuously across a 12-month time period
measure: Change in physiological stress response
timeFrame: Continuously across a 12-month time period
measure: Change in medication use
timeFrame: Baseline and every day up to month 12
measure: Adverse side effects
timeFrame: Baseline and every week up to month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Vall d'Hebron Research Institute
city: London
country: United Kingdom
facility: King's College London
Study officials:
affiliation: Social, Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London
name: Jonna Kuntsi, BSc, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References: