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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04228094
Recruitment Status : Recruiting
First Posted : January 14, 2020
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
Xavier Castells, Universitat de Girona

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.

Condition or disease Intervention/treatment
Attention Deficit-hyperactivity Disorder 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 First, many GPC are outdated shortly after their publication.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.

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Study Type : Observational
Estimated Enrollment : 55 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : August 10, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Treatment recommended/prescribed [ Time Frame: 4 days ]
    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.


Secondary Outcome Measures :
  1. Patient/parent satisfaction with the participation in the health decision-making process [ Time Frame: 3 weeks ]
    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.

  2. Patient/parent satisfaction with TDApp1 [ Time Frame: 3 weeks ]
    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. ADHD symptom severity [ Time Frame: 3 weeks ]
    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.

  4. Adverse events [ Time Frame: 3 weeks ]
    The incidence of adverse events will be collected by means of a questionnaire

  5. Patient/parent satisfaction with the treatment prescribed [ Time Frame: 3 weeks ]
    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.

  6. Physical activity [ Time Frame: 3 weeks ]
    The physical activity will be measured by means of ActiGraph wGT3X-BT that records continuous physical activity and sleep/wake information.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
ADHD patients will be recruited from specialiazed setting.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04228094


Contacts
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Contact: Xavier Castells, MD, PhD 34 972 41 96 16 xavier.castells@udg.edu

Locations
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Spain
Institut d'Assitència Sanitària Recruiting
Girona, Catalonia, Spain, 17003
Contact: Domènec Serrano, MD, PhD         
Sponsors and Collaborators
Universitat de Girona
Investigators
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Principal Investigator: Xavier Castells, MD, PhD Universitat de Girona
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Responsible Party: Xavier Castells, Development of a web application to formulate participatory, individualized and automated therapeutic recommendations for the treatment of patients with ADHD, Universitat de Girona
ClinicalTrials.gov Identifier: NCT04228094    
Other Study ID Numbers: tdapp1
First Posted: January 14, 2020    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xavier Castells, Universitat de Girona:
eHealth
evidence based medicine
machine learning
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases