ADHD Remote Technology Study of Cardiometabolic Risk Factors and Medication Adherence

NCT05301673 | Active Not Recruiting

• 1 other identifier: 304278
• Study Type: observational
• Target: 600
• Locations: 2 countries
• Sites: 2

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.

Conditions

Attention Deficit Hyperactivity Disorder; Cardiovascular Diseases; Medication Adherence

Keywords

ADHD; attention-deficit/hyperactivity disorder; remote measurement technology; mHealth; cardiovascular disease; medication adherence

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (2)

Adults with ADHD

Partner, family member or close friend of the individuals with ADHD

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (2)

Vall d'Hebron Research Institute

Barcelona, Spain

Location

King's College London

London, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA saliva samples

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Cardiovascular Diseases; Medication Adherence

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Jonna Kuntsi, BSc, MSc, PhD

  Social, Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: March 31, 2022
• Study Start: July 12, 2022
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); ES (1)