NCT04228094

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 14, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

August 10, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2022

Completed
Last Updated

September 22, 2022

Status Verified

September 1, 2022

Enrollment Period

1.7 years

First QC Date

January 10, 2020

Last Update Submit

September 20, 2022

Conditions

Attention Deficit-hyperactivity Disorder

Keywords

eHealthevidence based medicinemachine learning

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Patient/parent satisfaction with the participation in the health decision-making process

    3 weeks

  • Patient/parent satisfaction with TDApp1

    3 weeks

  • ADHD symptom severity

    3 weeks

  • Adverse events

    3 weeks

  • Patient/parent satisfaction with the treatment prescribed

    3 weeks

  • +1 more secondary outcomes

Study Arms (1)

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

Interventions

TDApp1: an eHealth interventionOTHER

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

TDApp1

Eligibility Criteria

Age6 Years - 65 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ADHD patients will be recruited from specialiazed setting.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut d'Assitència Sanitària

Girona, Catalonia, 17003, Spain

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Xavier Castells, MD, PhD

    Universitat de Girona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Development of a web application to formulate participatory, individualized and automated therapeutic recommendations for the treatment of patients with ADHD

Study Record Dates

First Submitted

January 10, 2020

First Posted

January 14, 2020

Study Start

August 10, 2020

Primary Completion

May 9, 2022

Study Completion

May 9, 2022

Last Updated

September 22, 2022

Record last verified: 2022-09

Locations

ES(1)