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

Attention Deficit-hyperactivity Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04228094
• Other study ID #: tdapp1
• Status: Completed
• Start date: August 10, 2020
• Est. completion date: May 9, 2022

Study information

• Verified date: September 2022
• Source: Universitat de Girona
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 First, many GPC are outdated shortly after their publication.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: May 9, 2022
• Est. primary completion date: May 9, 2022
• Gender: All
• Age group: 6 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit-hyperactivity Disorder
• Hyperkinesis

Intervention

Other:
• 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

Locations

Country	Name	City	State
Spain	Institut d'Assitència Sanitària	Girona	Catalonia

Sponsors (1)

Lead Sponsor	Collaborator
Universitat de Girona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment recommended/prescribed	Treatment recommended/prescribed consists on the treatment recommended to the patient with ADHD by TDApp1 and the actual treatment prescribed by the investigator to this patient.	4 days
Secondary	Patient/parent satisfaction with the participation in the health decision-making process	Satisfaction of the patients or their parents with their participation in the health decision-making process. This outcome will be collected by means of visual analogic scale that has been developed for this study. Score ranges from 1 to 9. Higher scores indicate greater satisfaction.	3 weeks
Secondary	Patient/parent satisfaction with TDApp1	The satisfaction of the patients or their parents with the educational material provided, and the usability and simplicity of TDApp1. This outcome will be collected by means of visual analogic scale that has been developed for this study. Score ranges from 1 to 9. Higher scores indicate greater satisfaction.	3 weeks
Secondary	ADHD symptom severity	ADHD symptom severity will be assessed with the self-rated, 18-item, DSM V (in children and adolescents) or IV-TR (in adults) -based Rating Scale. Total score ranges from 0 to 54. Higher total scores indicate greater illness severity.	3 weeks
Secondary	Adverse events	The incidence of adverse events will be collected by means of a questionnaire	3 weeks
Secondary	Patient/parent satisfaction with the treatment prescribed	Satisfaction of the patients or their parents with the prescribed treatment. This outcome will be collected by means of visual analogic scale that has been developed for this study. Score ranges from 1 to 9. Higher scores indicate greater satisfaction.	3 weeks
Secondary	Physical activity	The physical activity will be measured by means of ActiGraph wGT3X-BT that records continuous physical activity and sleep/wake information.	3 weeks