Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-26 @ 12:02 AM
Study NCT ID:
NCT04228094
Status:
COMPLETED
Last Update Posted:
2022-09-22
First Post:
2020-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assesment of TDApp1 an eHelath Tool to Make Therapeutic Recommendations for Patients With ADHD
Sponsor:
Universitat de Girona
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 First, many GPC are outdated shortly after their publication.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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: