Assesment of TDApp2 an eHelath Tool to Make Pharmacologic and Non-pharmacologic Treatment Recommendations for Patients With ADHD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Treatment recommended
研究概览
简要总结
The purpose of this study is to compare the recommendations made by TDApp2 with those by relevant clinical practice guidelines in children/adolescents with ADHD.
详细描述
Clinical practice guidelines (CPG) allow optimizing medical decisions and health care based on the best evidence available. Nevertheless, CPGs have several limitations. First, many GPC are outdated shortly after their publication. Second, CPG recommendations are often not applicable to many patients treated in clinical practice. Most CPGs do not make recommendations for complex patients with comorbidities. Another limitation is that patients involvement in CPGs development is still poor. To overcome these limitations, study investigators developed TDApp, an eHealth tool to formulate decentralized, participatory, individualized and automated pharmacologic treatment recommendations for patients with Attention Deficit Hyperactivity Disorder. TDApp was initially tested in a clinical sample of ADHD patients (https://clinicaltrials.gov/ct2/show/NCT04228094), but, as it was the first human use, treatment recommendations were kept hidden to the clinicians until the last patient enrolled completed study participation. This safeguard was implemented to avoid potential misguidance. After completing this study, the investigators developed a new iteration of TDApp (TDApp2) that can also recommend non-pharmacological interventions.
In this study, the investigators aim to assess TDApp2: an eHealth tool that formulates participatory, participatory, explainatory and automated therapeutic recommendations for patients with Attention Deficit Hyperactivity Disorder. The recommendations made by TDApp2 will be compared with those made by relevant clinical practice guidelines in children/adolescents with ADHD.
A 6-week, one group, open label study will be conducted. Tirty-two children/adolescents aged < 18 yo with ADHD and their parents will use TDApp. The treatment recommendations made by the TDApp2 will be compared to those made by relevant CPG (American Academy of Pediatrics CPG, Canadian ADHD Resource Alliance (CADDRA) GPC, National Institute for Health and Care Excellence (NICE) GPC, the Australian ADHD Professionals Association guideline, and the Spanish GPC). As the study will be carried out in Catalonia (Spain), the primary comparison will be performed vs. the Spanish CPG. Also, TDApp2 recommendations will be compared with the actual treatment prescribed by the clinicians.
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
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 6-17 yo
- •Meeting DSM 5 criteria for ADHD
- •Requiring treatment initiation for ADHD or requiring a treatment change
排除标准
- •Patients who are receiving treatment for ADHD and who are well controlled with it
- •Patients who do not have a suitable electronic device for TDApp2
结局指标
主要结局
Treatment recommended
时间窗: Week 1
Treatment recommended consists on the treatment recommended to the patient with ADHD by TDApp2 and CPG. The number and type of recommended treatments will be compared.
次要结局
- Sense of coherence as assessed by the Sense of Coherence (SOC)-13 by Antonovsky(Week 1 and week 3)
- Patient satisfaction with the decision-making process as assessed by a 5-point Likert scale(Week 1)
- Perceived usefulness of the clinical recommendations as assessed by a 5-point Likert scale(Week 1)
- Adverse events(Weeks 3 and 6)
- Individuals' confidence in their capacity to act in the ways necessary to reach specific goals as assessed by the Bäbler, Schwarzar, and Jerusalem self-efficacy scale(Week 1 and week 3)
- Knowledge about ADHD as assessed by an ad hoc test(Week 1 and week 3)
- Treatment prescribed(Week 1)
- Clinicians satisfaction with the treatment recommendations formulated by TDApp2 as assessed by a 5-point Likert scale(Week 6)
- Pharmacological distance according to the the NbN2R classification(Week 1)
- ADHD symptom severity as assessed by the DSM 5 Attention-Deficit/Hyperactivity Disorder Rating Scale(Baseline and week 6)
- Global assessment of severity of illness as assessed by the Clinical Global Impression - Severity of Illness (CGI-S) Scale(Baseline and week 6)
- Health literacy as assessed by the health literacy questionnaire 16-item, European Health Literacy Survey Questionnaire (HLS-EU-Q16)(Week 1 and week 3)
- Patient satisfaction with the educational material as assessed by a 5-point Likert scale(Week 1)
- Patient perceived satisfaction with the treatment as assessed by a 5-point Likert scale(Week 6)
研究者
Xavier Castells
Principal Investigator
Universitat de Girona