Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| South London and Maudsley NHS Foundation Trust | OTHER |
| Barnet, Enfield and Haringey Mental Health NHS Trust | OTHER_GOV |
| Hospital Universitari Vall d'Hebron Research Institute | OTHER |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults with ADHD | |||
| Partner, family member or close friend of the individuals with ADHD |
Not provided
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jonna Kuntsi, BSc, MSc, PhD | Social, Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vall d'Hebron Research Institute | Barcelona | Spain | ||||
| King's College London |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D002318 | Cardiovascular Diseases |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D010349 | Patient Compliance |
Not provided
Not provided
| Empatica, Inc. | INDUSTRY |
| Örebro University, Sweden | OTHER |
| Concentris research management gmbh | UNKNOWN |
| Attention Deficit Disorder Information and Support Service | UNKNOWN |
| The European Association for the Study of Obesity | UNKNOWN |
| Northumberland, Tyne and Wear NHS Foundation Trust | OTHER |
| Tees, Esk and Wear Valleys NHS Foundation Trust | UNKNOWN |
| South West London and St George's Mental Health NHS Trust | OTHER |
| East London NHS Foundation Trust | OTHER_GOV |
| Avon and Wiltshire Mental Health Partnership NHS Trust | OTHER_GOV |
Not provided
Not provided
Not provided
DNA saliva samples
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 |
| London |
| United Kingdom |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |