Assesment of TDApp1 an eHelath Tool to Make Therapeutic Recommendations for Patients With ADHD

NCT ID: NCT04228094

Last Updated: 2022-09-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 33 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-10
• Study Completion Date: 2022-05-09

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 First, many GPC are outdated shortly after their publication.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

Conditions

Attention Deficit-hyperactivity Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

TDApp1

This cohort will use TDApp1: an eHealth tool to formulate participatory, individualized and automated therapeutic recommendations for patients with Attention Deficit Hyperactivity Disorder

TDApp1: an eHealth intervention

Intervention Type: OTHER

TDApp1 is a tool that uses GRADE heuristics to formulate participatory, individualized and automated therapeutic recommendations for patients with Attention Deficit Hyperactivity Disorder

Interventions

TDApp1: an eHealth intervention

TDApp1 is a tool that uses GRADE heuristics to formulate participatory, individualized and automated therapeutic recommendations for patients with Attention Deficit Hyperactivity Disorder

Intervention Type: OTHER

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitat de Girona

OTHER

Sponsor Role: lead

Responsible Party

Xavier Castells

Development of a web application to formulate participatory, individualized and automated therapeutic recommendations for the treatment of patients with ADHD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xavier Castells, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitat de Girona

Locations

Institut d'Assitència Sanitària

Girona, Catalonia, Spain

Countries

Spain

Other Identifiers

tdapp1

Identifier Type: -

Identifier Source: org_study_id