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

September 20, 2022 updated by: Xavier Castells, Universitat de Girona

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

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 First, many GPC are outdated shortly after their publication.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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
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
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.
4 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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