ADHD Remote Technology Study of Cardiometabolic Risk Factors and Medication Adherence

Cardiovascular Diseases Clinical Trial

— ART-CARMA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05301673
• Other study ID #: 304278
• Status: Recruiting
• Start date: July 12, 2022
• Est. completion date: March 2025

Study information

• Verified date: October 2023
• Source: King's College London
• Contact: Hayley Denyer, BSc
• Phone: 02078485308
• Email: hayley.denyer[@]kcl.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Cardiovascular Diseases
• Hyperkinesis
• Medication Adherence

Locations

Country	Name	City	State
Spain	Vall d'Hebron Research Institute	Barcelona
United Kingdom	King's College London	London

Sponsors (14)

Lead Sponsor

Collaborator

King's College London

Attention Deficit Disorder Information and Support Service, Avon and Wiltshire Mental Health Partnership NHS Trust, Barnet, Enfield and Haringey Mental Health NHS Trust, Concentris research management gmbh, Cumbria, Northumberland Tyne and Wear NHS Foundation Trust, East London NHS Foundation Trust, Empatica, Inc., Hospital Universitari Vall d'Hebron Research Institute, Örebro University, Sweden, South London and Maudsley NHS Foundation Trust, South West London and St George's Mental Health NHS Trust, Tees, Esk and Wear Valleys NHS Foundation Trust, The European Association for the Study of Obesity

Countries where clinical trial is conducted

Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in heart rate	EmbracePlus wearable device	Continuously across a 12-month time period
Primary	Change in blood pressure	Blood pressure will be measured by participant	Baseline and every 4 weeks up to month 12
Primary	Change in weight	Weight (in kg) will be measured by participant	Baseline and every 4 weeks up to month 12
Primary	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
Primary	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
Primary	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
Primary	Change in sleep	EmbracePlus wearable device	Continuously across a 12-month time period
Primary	Change in physiological stress response	EmbracePlus wearable device	Continuously across a 12-month time period
Primary	Change in medication use	Non-validated daily medication use questionnaire. 3-items	Baseline and every day up to month 12
Primary	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