Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05551689 |
| Other study ID # |
2021-0084 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 21, 2021 |
| Est. completion date |
March 30, 2023 |
Study information
| Verified date |
May 2024 |
| Source |
Hospital de Clinicas de Porto Alegre |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The study is a randomized clinical trial to evaluate the efficacy on treatment adherence,
performance and usability of the mobile health solution FOCUS ADHD, in combination with a
discount application in the purchase of psychostimulant medication by adult patients with
ADHD
Description:
Current technological and digital advances enable the development and implementation of
innovative and effective strategies in the diagnosis, treatment, and follow-up of patients
with ADHD and other mental disorders. Such tools have the potential to significantly improve
the services provided with a patient-centred approaches, expand and facilitate access to and
support for treatment of adults with ADHD and other mental disorders. However, the levels of
scientific evidence of such solutions are still limited and more studies are needed for their
evaluation in different contexts and populations. The expectation is that such mHealth
devices can help in the diagnosis, identification, and early detection of individuals at
higher risk, allowing the development of individualized and more efficient approaches. At the
same time, offering integrated, multidisciplinary, continuous, and accurate monitoring.
This project aims to evaluate the efficacy of the FOCUS ADHD in treatment adherence, symptom
control and psychoeducation for the follow-up of ADHD patients. This implementation aims to
involve health professionals and ADHD patients into a participatory, dynamic social processes
to evaluate the proposed solution. In addition to the implementation of FOCUS ADHD, this
study will also evaluate the impact on granting a discount on the purchase of psychostimulant
medication. In Brazil, with some state exceptions, access to psychostimulant medication for
ADHD treatment is not offered free of charge to the population by the State. Therefore, \the
patient needs to pay out-of-pocket cost to acquire ADHD medications. The cost and access to
medication is a significant factor for treatment abandonment. Thus, we intend to evaluate
whether the granting of a significant discount on the acquisition of medication can have a
positive impact on the treatment of adult patients with ADHD. This is three arms randomized
clinical trial involving 60 adult ADHD patients that will be monitored for 3 months. One arm
will be evaluating the impact of FOCUS ADHD app on treatment adherence. A second arm will be
evaluating the FOCUS ADHD App plus the eligibility to receive the discount on the medication
purchase. The third Arm will be based on current practices of ADHD patient follow up
(treatment as usual). The patients will be recruited through public calls led by the
Attention Deficit/Hyperactivity Program (PRODAH-A) of the Hospital de Clínicas de Porto
Alegre (HCPA), Federal University of Rio Grande do Sul (UFRGS), Brazil. The primary outcomes
will be evaluated by comparing the groups that used the mHealth FOCUS ADHD tool and the
control that will not use them in the application. The primary outcome are:
- Adherence to pharmacological treatment of ADHD: Assess whether the use of the FOCUS ADHD
application as a monitoring and education tool: (1) Increases by 10% the ADHD
pharmacological treatment in adult patients compared to the control intervention. (2)
Evaluate if a discount concession on ADHD pharmacological treatment increases by 20% the
treatment adherence compared to the control intervention.
- ADHD knowledge and psychoeducation: Evaluate whether the use of the FOCUS ADHD
application as a psychoeducation tool produces a at least 10% greater increase on
knowledge about ADHD versus the control group.
Secondary outcomes will be evaluated exclusively with FOCUS ADHD application users. It will
be evaluated levels of adoption, retention, and usability of the FOCUS ADHD application by
enrolled participants. For the secondary outcomes evaluation, the following aspects will be
analysed:
1. Adoption: Assess whether at least 50% patients have established with their respective
physicians a collaborative network of ADHD monitoring through the FOCUS ADHD
application. Assess whether at least 50% patients registered the medications in the
Tasks and Medications icon. Assess whether at least 50% of patients filled out the ASRS
symptom assessment at least once in the application. To verify whether at least 50% of
patients-maintained access at least once a week to the news and psychoeducation contents
of FOCUS in the period evaluated.
2. Retention: Examine whether at least 50% of patients who used the FOCUS ADHD app recorded
at least 80% of days taking the daily medication on the evaluation period.
3. Usability assessment by implementing the User Version of the Mobile Application Rating
Scale (uMARS). Obtain an average minimum score greater than or equal to 3 in the
evaluations performed by users.
