ADHD Remote Technology Study of Cardiometabolic Risk Factors and Medication Adherence ('ART-CARMA')
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Adverse side effects
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Does not start ADHD medication following ADHD diagnosis (either due to personal choice or psychiatrist deciding not to prescribe ADHD medication)
结局指标
主要结局
Adverse side effects
时间窗: 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).
Change in diet
时间窗: 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
时间窗: Continuously across a 12-month time period
EmbracePlus wearable device
Change in medication use
时间窗: Baseline and every day up to month 12
Non-validated daily medication use questionnaire. 3-items
Change in heart rate
时间窗: Continuously across a 12-month time period
EmbracePlus wearable device
Change in alcohol use
时间窗: 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 weight
时间窗: Baseline and every 4 weeks up to month 12
Weight (in kg) will be measured by participant
Change in smoking
时间窗: 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 blood pressure
时间窗: Baseline and every 4 weeks up to month 12
Blood pressure will be measured by participant
Change in physiological stress response
时间窗: Continuously across a 12-month time period
EmbracePlus wearable device
次要结局
未报告次要终点