Clinical trial NCT04228094: Assesment of TDApp1 an eHelath Tool to Make Therapeutic Recommendations for Patients With ADHD
Official title: Development and Assesment of TDApp1 an eHelath Tool to Make Participatory, Patient-centred and Automated Therapeutic Recommendations for Patients With Attention Deficit Hyperactivity Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Attention Deficit-hyperactivity Disorder
Keywords: eHealth
evidence based medicine
machine learning
Lead sponsor: Universitat de Girona
Sponsor class: OTHER
First posted: 2020-01-14
Enrollment: 33
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ADHD patients will be recruited from specialiazed setting.

Brief summary: This is a 3-week open label, one group study to determine the agreement between the pharmacological treatment recommended by TDApp1 and the interventions recommended by relevant clinical practice guidelines.

Detailed description: Clinical practice guidelines (CPGP) 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 First, many GPC are outdated shortly after their publication.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 patients with a mild disorder or for complex patients with comorbiditie. Another limitation is that patients involvement in CPGs development is still poor.

We aim to develop and assess TDApp1: an eHealth tool to formulate participatory, individualized and automated therapeutic recommendations for patients with Attention Deficit Hyperactivity Disorder.

A 3-week, one group, open label study will be conducted. Fifty-five patients aged 6-65 with ADHD will use TDApp1. The therapeutic recommendations made by the TDApp1 and by relevant CPG will be compared. Concordance in the recommendations will be studied. Effectiveness, safety, changes in physical activity and satisfaction will be investigated.

Eligibility criteria: Inclusion Criteria:

* Male and female patients ages 6-65
* A diagnosis of DSM-V ADHD based on clinical assessment

Exclusion Criteria:

* Patients under adequate therapeutic treatment or requiring minor adjustments
* Patients lacking an electronic device (mobile phone, tablet,...) with internet access

Primary outcomes:
measure: Treatment recommended/prescribed
timeFrame: 4 days
Secondary outcomes:
measure: Patient/parent satisfaction with the participation in the health decision-making process
timeFrame: 3 weeks
measure: Patient/parent satisfaction with TDApp1
timeFrame: 3 weeks
measure: ADHD symptom severity
timeFrame: 3 weeks
measure: Adverse events
timeFrame: 3 weeks
measure: Patient/parent satisfaction with the treatment prescribed
timeFrame: 3 weeks
measure: Physical activity
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Girona
country: Spain
facility: Institut d'Assitència Sanitària
state: Catalonia
Study officials:
affiliation: Universitat de Girona
name: Xavier Castells, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: