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Completed

NCT Number: NCT04228094

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

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.

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Key information

Conditions

Attention Deficit-Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut d'Assitència Sanitària

Girona, Catalonia, 17003, Spain

About this study

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 First, many GPC are outdated shortly after their publication.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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TDApp1: an eHealth intervention

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Universitat de Girona

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 14, 2020
Registry last updated
Sep 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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