Treatment Recommendations for Patients With ADHD TDApp2

Universitat de Girona

Status: Completed

Conditions: Attention Deficit Disorder With Hyperactivity

Study type: Observational

Funder types: Other

Identifiers

NCT05651685

TDApp2

Details and patient eligibility

About

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.

Full description

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 First, many GPC are outdated shortly after their publication.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.

Enrollment: 32 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 6-17 yo
• Meeting DSM 5 criteria for ADHD
• Requiring treatment initiation for ADHD or requiring a treatment change

Exclusion criteria

• 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

Trial design

32 participants in 1 patient group

TDApp2

Description:

This cohort will use TDApp2: an eHealth tool that formulates participatory, individualized, explainatory and automated treatment recommendations for patients with Attention Deficit Hyperactivity Disorder