Attention Deficit Hyperactivity Disorder, Cardiovascular Diseases, Medication Adherence
Conditions
Keywords
ADHD, attention-deficit/hyperactivity disorder, remote measurement technology, mHealth, cardiovascular disease, medication adherence
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.
Interventions
None listed
Sponsors
South London and Maudsley NHS Foundation Trust
Barnet, Enfield and Haringey Mental Health NHS Trust
Hospital Universitari Vall d'Hebron Research Institute
Empatica, Inc.
Örebro University, Sweden
Concentris research management gmbh
Attention Deficit Disorder Information and Support Service
The European Association for the Study of Obesity
Northumberland, Tyne and Wear NHS Foundation Trust
Tees, Esk and Wear Valleys NHS Foundation Trust
South West London and St George's Mental Health NHS Trust
East London NHS Foundation Trust
Avon and Wiltshire Mental Health Partnership NHS Trust
King's College London
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Spain, United Kingdom
Outcome results
None listed