Attention Deficit Hyperactivity DisorderART-CARMANCT05301673
ADHD Remote Technology Study of Cardiometabolic Risk Factors and Medication Adherence
An observational study of Attention Deficit Hyperactivity Disorder and Cardiovascular Diseases, run by King's College London at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder, Cardiovascular Diseases, Medication Adherence
- How many people
- 600 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 12 Jul 2022to Mar 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: ADHD Remote Technology Study of Cardiometabolic Risk Factors and Medication Adherence ('ART-CARMA')
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.
- Keywords
- ADHD, attention-deficit/hyperactivity disorder, remote measurement technology, mHealth, cardiovascular disease, medication adherence
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Cardiovascular Diseases, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults with ADHD | Not described | |
| Partner, family member or close friend of the individuals with ADHD | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in heart rate
EmbracePlus wearable device
Measured: Continuously across a 12-month time period
Change in blood pressure
Blood pressure will be measured by participant
Measured: Baseline and every 4 weeks up to month 12
Change in weight
Weight (in kg) will be measured by participant
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and every 4 weeks up to month 12
Change in sleep
EmbracePlus wearable device
Measured: Continuously across a 12-month time period
Change in physiological stress response
EmbracePlus wearable device
Measured: Continuously across a 12-month time period
Change in medication use
Non-validated daily medication use questionnaire. 3-items
Measured: 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).
Measured: Baseline and every week up to month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start12 Jul 2022
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor
- Investigators
- Jonna Kuntsi, BSc, MSc, PhD, Principal investigator, Social, Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05301673
- Sponsor's protocol ID
- 304278
- Acronym
- ART-CARMA
- Status last verified
- Dec 2024
- First submitted
- 11 Mar 2022
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADHD Remote Technology Study of Cardiometabolic Risk Factors and Medication Adherence ('ART-CARMA')
- ClinicalTrials.gov ID
- NCT05301673
- Acronym / sponsor ID
- ART-CARMA / 304278
- Keywords
- ADHD, attention-deficit/hyperactivity disorder, remote measurement technology, mHealth, cardiovascular disease, medication adherence
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- 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
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adults with ADHD | – | – |
| Partner, family member or close friend of the individuals with ADHD | – | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in heart rate
Time frame: Continuously across a 12-month time period
EmbracePlus wearable device
Change in blood pressure
Time frame: Baseline and every 4 weeks up to month 12
Blood pressure will be measured by participant
Change in weight
Time frame: Baseline and every 4 weeks up to month 12
Weight (in kg) will be measured by participant
Change in smoking
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Continuously across a 12-month time period
EmbracePlus wearable device
Change in physiological stress response
Time frame: Continuously across a 12-month time period
EmbracePlus wearable device
Change in medication use
Time frame: Baseline and every day up to month 12
Non-validated daily medication use questionnaire. 3-items
Adverse side effects
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonna Kuntsi, BSc, MSc, PhD principal investigator
Social, Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Hyperactivity Disorder and Cardiovascular Diseases, run by King's College London at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in heart rate (time frame: Continuously across a 12-month time period). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.