Clinical trial NCT05551689: FOCUS ADHD Mobile Health App for Adult ADHD Patients
Official title: Evaluation of the Effectiveness of the FOCUS ADHD Mobile Health Platform in the Monitoring of Adults With Attention-Deficit/ Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Keywords: mhealth
app
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo
First posted: 2022-09-23
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized clinical trial
Primary purpose: SUPPORTIVE_CARE

Brief 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

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Subject is willing and able to comply with all requirements of the study;
* Subject is able to provide written consent;
* Subject has a diagnosis of ADHD according to DSM-5;
* age 45 \< 18 years;
* own smartphone;
* ASRS score at diagnosis ≥ 24
* Subject accepts usage of pharmacological treatment for ADHD during the study;

Exclusion Criteria:

* patients with any unstable or chronic clinical disease without adequate treatment, notified arterial hypertension, heart, kidney or liver diseases;
* presence of unstable psychiatric comorbidities requiring immediate treatment such as depression at risk of suicide or substance abuse/dependence, including anxiety and bipolar disorder. current or past history of psychosis;
* Patients with incomplete high school

Primary outcomes:
measure: Adherence to pharmacological treatment of ADHD
timeFrame: Treatment adherence will be monitored through weekly telephone contact. Week 1 to 12.
measure: ADHD Knowledge Change
timeFrame: The participants knowledge on ADHD should be carried out in two moments to evaluate the change or not of participants ADHD knowledge. At the beginning of the study on the baseline assessment and at the end of the follow-up period (Week 12)
Secondary outcomes:
measure: FOCUS ADHD Adoption
timeFrame: End of the follow up period (Week 12)
measure: FOCUS ADHD Retention
timeFrame: Weekly assessments Week 1 to Week 12
measure: FOCUS ADHD Usability
timeFrame: End of the follow up period (Week 12)
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Hospital das Clínicas de Porto Alegre
name: Luis Augusto P Rohde, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: