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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Medication Adherence; Attention Deficit Hyperactivity Disorder

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Hayley Denyer, BSc; Phone Number: 02078485308; Email: hayley.denyer@kcl.ac.uk

Study Locations

• Spain
  • Barcelona, Spain
    • Not yet recruiting
    • Vall d'Hebron Research Institute
    • Contact: Carolina Ramos; Email: carolina.ramos@vhir.org
    • Principal Investigator: José Antonio Ramos Quiroga
• United Kingdom
  • London, United Kingdom
    • Recruiting
    • King's College London
    • Contact: Hayley Denyer, BSc; Email: hayley.denyer@kcl.ac.uk
    • Principal Investigator: Jonna Kuntsi, PhD
    • Sub-Investigator: Richard Dobson, PhD
    • Sub-Investigator: Amos Folarin, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Adults with ADHD
Partner, family member or close friend of the individuals with ADHD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in heart rate	EmbracePlus wearable device	Continuously across a 12-month time period
Change in blood pressure	Blood pressure will be measured by participant	Baseline and every 4 weeks up to month 12
Change in weight	Weight (in kg) will be measured by participant	Baseline and every 4 weeks up to month 12
Change in smoking	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.	Baseline and every 4 weeks up to month 12
Change in alcohol use	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.	Baseline and every 4 weeks up to month 12
Change in diet	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.	Baseline and every 4 weeks up to month 12
Change in sleep	EmbracePlus wearable device	Continuously across a 12-month time period
Change in physiological stress response	EmbracePlus wearable device	Continuously across a 12-month time period
Change in medication use	Non-validated daily medication use questionnaire. 3-items	Baseline and every day up to month 12
Adverse side effects	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).	Baseline and every week up to month 12

Collaborators and Investigators

• Sponsor: King's College London
• Collaborators: Hospital Universitari Vall d'Hebron Research Institute; Örebro University, Sweden; South London and Maudsley NHS Foundation Trust; Empatica, Inc.; Cumbria, Northumberland Tyne and Wear NHS Foundation Trust; Avon and Wiltshire Mental Health Partnership NHS Trust; Tees, Esk and Wear Valleys NHS Foundation Trust; Concentris research management gmbh; South West London and St George's Mental Health NHS Trust; Barnet, Enfield and Haringey Mental Health NHS Trust; Attention Deficit Disorder Information and Support Service; The European Association for the Study of Obesity; East London NHS Foundation Trust
• Investigators: Principal Investigator: Jonna Kuntsi, BSc, MSc, PhD, Social, Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2022
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: March 11, 2022
• First Submitted That Met QC Criteria: March 22, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: ADHD; cardiovascular disease; mHealth; medication adherence; attention-deficit/hyperactivity disorder; remote measurement technology
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Cardiovascular Diseases; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: 304278

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No