ADHD Remote Technology Study of Cardiometabolic Risk Factors and Medication Adherence

NCT ID: NCT05301673

Last Updated: 2024-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-12

Study Completion Date

2025-03-31

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.

Detailed Description

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Conditions

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Attention Deficit Hyperactivity Disorder Cardiovascular Diseases Medication Adherence

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adults with ADHD

No interventions assigned to this group

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

No interventions assigned to this group

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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South London and Maudsley NHS Foundation Trust

OTHER

Sponsor Role collaborator

Barnet, Enfield and Haringey Mental Health NHS Trust

OTHER_GOV

Sponsor Role collaborator

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role collaborator

Empatica, Inc.

INDUSTRY

Sponsor Role collaborator

Örebro University, Sweden

OTHER

Sponsor Role collaborator

Concentris research management gmbh

UNKNOWN

Sponsor Role collaborator

Attention Deficit Disorder Information and Support Service

UNKNOWN

Sponsor Role collaborator

The European Association for the Study of Obesity

UNKNOWN

Sponsor Role collaborator

Northumberland, Tyne and Wear NHS Foundation Trust

OTHER

Sponsor Role collaborator

Tees, Esk and Wear Valleys NHS Foundation Trust

UNKNOWN

Sponsor Role collaborator

South West London and St George's Mental Health NHS Trust

OTHER

Sponsor Role collaborator

East London NHS Foundation Trust

OTHER_GOV

Sponsor Role collaborator

Avon and Wiltshire Mental Health Partnership NHS Trust

OTHER_GOV

Sponsor Role collaborator

King's College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonna Kuntsi, BSc, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Vall d'Hebron Research Institute

Barcelona, , Spain

Site Status

King's College London

London, , United Kingdom

Site Status

Countries

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Spain United Kingdom

Other Identifiers

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304278

Identifier Type: -

Identifier Source: org_study_id