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

Development and Assesment of TDApp1 an eHelath Tool to Make Participatory, Patient-centred and Automated Therapeutic Recommendations for Patients With Attention Deficit Hyperactivity Disorder

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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit-hyperactivity Disorder
• Intervention / Treatment: Other: TDApp1: an eHealth intervention

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 First, many GPC are outdated shortly after their publication.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

• Study Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• Spain
  • Catalonia
    • Girona, Catalonia, Spain, 17003
      • Institut d'Assitència Sanitària

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 65 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

ADHD patients will be recruited from specialiazed setting.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Adverse events	The incidence of adverse events will be collected by means of a questionnaire	3 weeks
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
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

Collaborators and Investigators

• Sponsor: Universitat de Girona
• Investigators: Principal Investigator: Xavier Castells, MD, PhD, Universitat de Girona

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 10, 2020
• Primary Completion (ACTUAL): May 9, 2022
• Study Completion (ACTUAL): May 9, 2022

Study Registration Dates

• First Submitted: January 10, 2020
• First Submitted That Met QC Criteria: January 10, 2020
• First Posted (ACTUAL): January 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 22, 2022
• Last Update Submitted That Met QC Criteria: September 20, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: machine learning; eHealth; evidence based medicine
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: tdapp1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No