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Clinical trial

Evaluation of the Effectiveness of the FOCUS ADHD Mobile Health Platform in the Monitoring of Adults With Attention-Deficit/ Hyperactivity Disorder (ADHD)

ID
Name
2021-0084
Description
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 arms
Trial start
2021-05-21
Estimated PCD
2022-09-30
Trial end
2023-03-30
Status
Completed
Treatment
Psychostimulant
All enrolled patients should be receiving ADHD pharmacological treatment (psychostimulants)
Arms:
ADHD monitoring as usual, FOCUS ADHD, FOCUS ADHD and the elegibility for discount concession on treatment purchase
Other names:
Methilphenidate, Lisdexamfetamine
FOCUS ADHD App
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)
Arms:
FOCUS ADHD, FOCUS ADHD and the elegibility for discount concession on treatment purchase
Other names:
mhealth app
Size
73
Primary endpoint
Adherence to pharmacological treatment of ADHD
Treatment adherence will be monitored through weekly telephone contact. Week 1 to 12.
ADHD Knowledge Change
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)
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized clinical trial', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Participants are randomized by an independent assistant.', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 73, 'type': 'ACTUAL'}}
Updated at
2024-05-16

1 organization

1 product

1 indication

Organization
Hospital de Clinicas de Porto Alegre
Product
Psychostimulant
Indication
ADHD