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

Sponsor

King's College London (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05301673

Collaborator

South London and Maudsley NHS Foundation Trust (Other), Barnet, Enfield and Haringey Mental Health NHS Trust (Other), Hospital Universitari Vall d'Hebron Research Institute (Other), Empatica, Inc. (Industry), Örebro University, Sweden (Other), Concentris research management gmbh (Other), Attention Deficit Disorder Information and Support Service (Other), The European Association for the Study of Obesity (Other)

600

Enrollment

Locations

Anticipated Duration (Months)

300

Patients Per Site

8.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Hyperactivity Disorder Cardiovascular Diseases Medication Adherence

Study Design

Study Type:

Observational

Anticipated Enrollment :

600 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Adults with ADHD
Partner, family member or close friend of the individuals with ADHD

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vall d'Hebron Research Institute	Barcelona		Spain
2	King's College London	London		United Kingdom

Investigators

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