Clinical trial NCT05651685: Treatment Recommendations for Patients With ADHD TDApp2
Official title: Assesment of TDApp2 an eHelath Tool to Make Pharmacologic and Non-pharmacologic Treatment Recommendations for Patients With ADHD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: eHealth
evidence based medicine
clinical decission support systems
Lead sponsor: Universitat de Girona
Sponsor class: OTHER
Collaborators: name: Institut d'Assistència Sanitària
First posted: 2022-12-15
Enrollment: 32
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adolescents with ADHD requiring treatment initiation for ADHD or requiring a treatment change will be enrolled for 6 weeks.

Brief summary: 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.

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 First, many GPC are outdated shortly after their publication.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

Eligibility criteria: 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

Primary outcomes:
measure: Treatment recommended
timeFrame: Week 1
Secondary outcomes:
measure: Pharmacological distance according to the the NbN2R classification
timeFrame: Week 1
measure: ADHD symptom severity as assessed by the DSM 5 Attention-Deficit/Hyperactivity Disorder Rating Scale
timeFrame: Baseline and week 6
measure: Global assessment of severity of illness as assessed by the Clinical Global Impression - Severity of Illness (CGI-S) Scale
timeFrame: Baseline and week 6
measure: Sense of coherence as assessed by the Sense of Coherence (SOC)-13 by Antonovsky
timeFrame: Week 1 and week 3
measure: 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
timeFrame: Week 1 and week 3
measure: Health literacy as assessed by the health literacy questionnaire 16-item, European Health Literacy Survey Questionnaire (HLS-EU-Q16)
timeFrame: Week 1 and week 3
measure: Knowledge about ADHD as assessed by an ad hoc test
timeFrame: Week 1 and week 3
measure: Treatment prescribed
timeFrame: Week 1
measure: Patient satisfaction with the educational material as assessed by a 5-point Likert scale
timeFrame: Week 1
measure: Patient satisfaction with the decision-making process as assessed by a 5-point Likert scale
timeFrame: Week 1
measure: Perceived usefulness of the clinical recommendations as assessed by a 5-point Likert scale
timeFrame: Week 1
measure: Adverse events
timeFrame: Weeks 3 and 6
measure: Patient perceived satisfaction with the treatment as assessed by a 5-point Likert scale
timeFrame: Week 6
measure: Clinicians satisfaction with the treatment recommendations formulated by TDApp2 as assessed by a 5-point Likert scale
timeFrame: Week 6
Other outcomes:
Locations:
city: Salt
country: Spain
facility: Institut d'Assitència Sanitària
state: Catalonia
Study officials:
affiliation: Universitat de Girona
name: Xavier Castells
role: PRINCIPAL_INVESTIGATOR
References: