Attention Deficit-hyperactivity DisorderNCT04228094
Assesment of TDApp1 an eHelath Tool to Make Therapeutic Recommendations for Patients With ADHD
An observational study of Attention Deficit-hyperactivity Disorder, run by Universitat de Girona at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 65 years
- Conditions the study is for
- Attention Deficit-hyperactivity Disorder
- What is being tested?
- TDApp1: an eHealth intervention
- How many people
- 33 participants
- Where
- 1 siteSpain
- Study dates
- 10 Aug 2020to 9 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 65 years
- All sexes
- Child, Adult, Older adult
Study population: ADHD patients will be recruited from specialiazed setting.
Who may be able to join
- Male and female patients ages 6-65
- A diagnosis of DSM-V ADHD based on clinical assessment
Who cannot join
- Patients under adequate therapeutic treatment or requiring minor adjustments
- Patients lacking an electronic device (mobile phone, tablet,...) with internet access
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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 First, many GPC are outdated shortly after their publication.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.
- Conditions
- Attention Deficit-hyperactivity Disorder
- Being tested
- TDApp1: an eHealth intervention
- Keywords
- eHealth, evidence based medicine, machine learning
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TDApp1: an eHealth interventionOther
TDApp1 is a tool that uses GRADE heuristics to formulate participatory, individualized and automated therapeutic recommendations for patients with Attention Deficit Hyperactivity Disorder
| Study group | Role | What they receive |
|---|---|---|
| TDApp1 | This cohort will use TDApp1: an eHealth tool to formulate participatory, individualized and automated therapeutic recommendations for patients with Attention Deficit Hyperactivity Disorder Receives: Other: TDApp1: an eHealth intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment recommended/prescribed
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.
Measured: 4 days
Secondary outcomes (6)
Patient/parent satisfaction with the participation in the health decision-making process
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.
Measured: 3 weeks
Patient/parent satisfaction with TDApp1
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.
Measured: 3 weeks
ADHD symptom severity
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.
Measured: 3 weeks
Adverse events
The incidence of adverse events will be collected by means of a questionnaire
Measured: 3 weeks
Patient/parent satisfaction with the treatment prescribed
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.
Measured: 3 weeks
Physical activity
The physical activity will be measured by means of ActiGraph wGT3X-BT that records continuous physical activity and sleep/wake information.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start10 Aug 2020
- Primary completion9 May 2022
- Study completion9 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit-hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat de Girona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xavier Castells, Universitat de Girona
- Investigators
- Xavier Castells, MD, PhD, Principal investigator, Universitat de Girona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04228094
- Sponsor's protocol ID
- tdapp1
- Status last verified
- Sep 2022
- First submitted
- 10 Jan 2020
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04228094
- Acronym / sponsor ID
- tdapp1
- Conditions
- Attention Deficit-hyperactivity Disorder
- Keywords
- eHealth, evidence based medicine, machine learning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Universitat de GironaUniversity, hospital or other
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 9 May 2022 (actual)
- Study completion
- 9 May 2022 (actual)
- First posted
- 14 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TDApp1 | – | Other: TDApp1: an eHealth interventionThis cohort will use TDApp1: an eHealth tool to formulate participatory, individualized and automated therapeutic recommendations for patients with Attention Deficit Hyperactivity Disorder |
Who may qualify
- Ages
- 6 to 65 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- ADHD patients will be recruited from specialiazed setting.
Key inclusion criteria (2 listed)
- Male and female patients ages 6-65
- A diagnosis of DSM-V ADHD based on clinical assessment
Key exclusion criteria (2 listed)
- Patients under adequate therapeutic treatment or requiring minor adjustments
- Patients lacking an electronic device (mobile phone, tablet,...) with internet access
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TDApp1: an eHealth interventionTDApp1 is a tool that uses GRADE heuristics to formulate participatory, individualized and automated therapeutic recommendations for patients with Attention Deficit Hyperactivity Disorder | Other | TDApp1 |
Primary outcome
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.
6 secondary outcomes
Patient/parent satisfaction with the participation in the health decision-making process
Time frame: 3 weeks
Patient/parent satisfaction with TDApp1
Time frame: 3 weeks
ADHD symptom severity
Time frame: 3 weeks
Adverse events
Time frame: 3 weeks
Patient/parent satisfaction with the treatment prescribed
Time frame: 3 weeks
Physical activity
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier Castells, MD, PhD principal investigator
Universitat de Girona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit-hyperactivity Disorder, run by Universitat de Girona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment recommended/prescribed (time frame: 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2022.