FOCUS ADHD Mobile Health App for Adult ADHD Patients
Evaluation of the Effectiveness of the FOCUS ADHD Mobile Health Platform in the Monitoring of Adults With Attention-Deficit/ Hyperactivity Disorder (ADHD)
1 other identifier
interventional
73
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 21, 2021
CompletedFirst Submitted
Initial submission to the registry
September 16, 2022
CompletedFirst Posted
Study publicly available on registry
September 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2023
CompletedMay 16, 2024
May 1, 2024
1.4 years
September 16, 2022
May 14, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Adherence to pharmacological treatment of ADHD
Treatment adherence will be calculated using the medication possession ratio (MPR) as the total number of days provided for the medication, divided by the number of days between the first and last dispensation; An 80% MPR will be used as the cut-off point between adherence and non-adherence. For the group that includes the discount on medication it will be evaluated the frequency of registration in the medication intake in the FOCUS ADHD application database as eligibility criteria for the discount concession.
Treatment adherence will be monitored through weekly telephone contact. Week 1 to 12.
ADHD Knowledge Change
This is a questionnaire created in order to identify participants awareness about ADHD and the degree of information/misinformation about the disease and its management.
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 (3)
FOCUS ADHD Adoption
End of the follow up period (Week 12)
FOCUS ADHD Retention
Weekly assessments Week 1 to Week 12
FOCUS ADHD Usability
End of the follow up period (Week 12)
Study Arms (3)
ADHD monitoring as usual
ACTIVE COMPARATORADHD patient monitoring as usual based on psychostimulant prescription and follow up
FOCUS ADHD
EXPERIMENTALADHD patient monitoring as usual based on psychostimulant prescription and follow up plus the indication to use the FOCUS ADHD app as a treatment monitoring tool
FOCUS ADHD and the elegibility for discount concession on treatment purchase
EXPERIMENTALADHD patient monitoring as usual based on psychostimulant prescription and follow up plus the indication to use the FOCUS ADHD app as a treatment monitoring tool. In this arm patients are also eligible for a discount of at least 25% of the drug cost (after the first month of treatment) if they register and maintain at least 80% of their treatment adherence on the FOCUS ADHD app. The discount is granted after week 4 until the end of the follow up period.
Interventions
All enrolled patients should be receiving ADHD pharmacological treatment (psychostimulants)
FOCUS ADHD is a mobile health application to support ADHD treatment adherence, monitoring and psychoeducation. The App was developed by the Attention Deficit Hyperactivity Disorder Program (ProDAH) of the Hospital de Clínicas de Porto Alegre (HCPA) and the Federal University of Rio Grande do Sul (UFRGS)
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital de Clinicas de Porto Alegrelead
- University of Sao Paulocollaborator
Study Sites (1)
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-007, Brazil
Related Publications (1)
Carvalho LR, Haas LM, Zeni G, Victor MM, Techele SP, Marrone Castanho J, Meneghetti Coimbra I, de Freitas de Sousa A, Ceretta N, Garrudo A, Grevet EH, Rohde LA. Evaluation of the effectiveness of the FOCUS ADHD App in monitoring adults with attention-deficit/hyperactivity disorder. Eur Psychiatry. 2023 Jun 21;66(1):e53. doi: 10.1192/j.eurpsy.2023.2422.
PMID: 37341028DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luis Augusto P Rohde, MD-PhD
Hospital das Clínicas de Porto Alegre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- Participants are randomized by an independent assistant.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2022
First Posted
September 23, 2022
Study Start
May 21, 2021
Primary Completion
September 30, 2022
Study Completion
March 30, 2023
Last Updated
May 16, 2024
Record last verified: 2024-05