- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04228094
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
Study Overview
Status
Conditions
Intervention / Treatment
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 First, many GPC are outdated shortly after their publication.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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Catalonia
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Girona, Catalonia, Spain, 17003
- Institut d'Assitència Sanitària
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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?
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
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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.
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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
Sponsor
Investigators
- Principal Investigator: Xavier Castells, MD, PhD, Universitat de Girona
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- tdapp1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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