Clinical Trial: The Efficacy of Janssen's Icon Application (App) in Improving Adherence to Treatment With Stimulant Medications in Children With Attention Deficit/Hyperactivity Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Attention Module of the Kiddie-SADS questionniare
研究概览
简要总结
The overarching aim of the study is to assess the efficacy of Janssen's icon Application (App), a digital tool designed to improve adherence to medication treatment in children with ADHD.
Our specific hypotheses are:
- In children receiving medication for ADHD those provided with the App tool will be more adherent to treatment than children treated as usual (i.e., not provided with the App tool).
- Adherent patients will show greater improvement of ADHD symptoms and related dysfunction.
详细描述
Background and Rationale ADHD is one of the most common neurobehavioral disorders of childhood that affects approximately 6-10% of school-age children and is associated with significant impairment of cognitive and psychosocial functioning (1-3).
Psychostimulant medications are the most effective treatment for ADHD (4). Methylphenidate (MPH) is the drug of choice in Israel for children, adolescents and adults with ADHD and amphetamine derivatives are used when response to MPH is insufficient or when MPH is not tolerable (5).
Without adherence to treatment even the best medication will be ineffective. Adherence is defined as the extent to which a patient's actions correspond to the treatment recommendations of health care providers (6). The literature shows that adherence rates are lower for children as compared to adults, and for psychiatric patients as compared to medical patients (7). As a result, children with psychiatric disorders, such as ADHD, are at great risk for poor medication adherence.
Because of the long-term nature of the treatment, poor adherence turns out to be a crucial issue in ADHD treatment (8). Rates of stimulant adherence in children with ADHD vary considerably across studies but are generally stunningly low. For example, a large community study of urban elementary school children in the Philadelphia area found that only one in five of ADHD children treated with MPH adhered to the treatment (9).
Studies on adherence in children with ADHD suggest that predictors of poor adherence may include older age (10, 11), male gender (12), lower intelligence (12, 13), oppositional-defiant symptoms (13), lower socioeconomic status (14), three-times-daily regimen (10) and the presence of fewer symptoms of ADHD (15). Those who are adherent to their stimulant treatment are more likely to have more severe symptoms (11), high level of knowledge about ADHD, frequent clinical evaluation (16) and lack of proper family support (8).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Diagnosis of ADHD based on the DSM-5;
- •Age between 6 to 18 years
- •Eligible for receiving ADHD treatment with methylphenidate, mixed amphetamine salts, lisdexamfetamine or dexmethylphenidate
- •Parents own smart phone device.
- •Parents will sign a consent form
排除标准
- 未提供
研究组 & 干预措施
Application (App), a digital tool
Janssen's icon Application (App), a digital tool designed to improve adherence to medication treatment in children with ADHD.
干预措施: Janssen's icon Application (App) (Device)
结局指标
主要结局
Attention Module of the Kiddie-SADS questionniare
时间窗: 3 time points: baseline, after 1 month, 3 month after baseline
次要结局
- MINI-KID(3 time points: baseline, after 1 month, 3 month after baseline)
研究者
Prof. Doron Gothelf MD
Director of Child and Adolescent Psychiatry Unit
Sheba Medical Center