ADHD Remote Technology Study of Cardiometabolic Risk Factors and Medication Adherence

Study Overview
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Brief Summary
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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.

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

Conditions
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Attention Deficit Hyperactivity Disorder, Cardiovascular Diseases, Medication Adherence

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adults with ADHD<br> | |
| Partner, family member or close friend of the individuals with ADHD<br> | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, attention-deficit/hyperactivity disorder, remote measurement technology, mHealth, cardiovascular disease, medication adherence