Clinical trial NCT05137704: A Study on the Use of Healthcare Resources and Costs of Attention Deficit Hyperactivity Disorder (ADHD) in Adults in England
Official title: Healthcare Resources Utilization and Associated Costs of Adult ADHD in England
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2021-11-30
Enrollment: 2236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participant diagnosed with ADHD recorded between 01 January 2016 and 30 June 2018.

Brief summary: The main aim of the study is to learn about the demographic and clinical characteristics, healthcare resources utilization (HCRU) and costs associated with before and after ADHD diagnosis in England. No study medicines will be provided to participants in this study. The record available in Clinical Practice Research Datalink (CPRD) database and Hospital Episode Statistics (HES) database for ADHD participants will be assessed.


Eligibility criteria: Inclusion Criteria

1. Age greater than or equal to (\>=) 18 years at the beginning of the patient observation period (that is 18-months prior to the adult ADHD diagnosis to ensure they would have been seen in adult health care services).
2. First record of an adult ADHD diagnosis between 01st January 2016 and 30th June 2018.
3. Data availability in the database at least during the 18-months before and after the index date.

Exclusion Criteria

A participant will be excluded from the study if their CPRD linked to HES electronic medical record data includes:

1. Incomplete information for key demographics (that is, missing age or sex).
2. Clinical history of a diagnosis of ADHD during childhood or adolescence.
3. Prescription of a licensed adult ADHD medication (that is, methylphenidate, lisdexamfetamine, dexamfetamine, atomoxetine) during the pre-index period.

Primary outcomes:
measure: Number of General Practitioner (GP) Appointments
timeFrame: Up to approximately 36 months
measure: Number of Referrals to Psychiatrist
timeFrame: Up to approximately 36 months
measure: Number of Referrals by Specialist
timeFrame: Up to approximately 36 months
measure: Number of Outpatient Visits by Specialist
timeFrame: Up to approximately 36 months
measure: Number of Investigations Undergone
timeFrame: Up to approximately 36 months
measure: Number of Accident and Emergency Visits
timeFrame: Up to approximately 36 months
measure: Number of Reasons for Admission
timeFrame: Up to approximately 36 months
measure: Number of Inpatient Hospitalizations
timeFrame: Up to approximately 36 months
measure: Length of Stay in Hospital
timeFrame: Up to approximately 36 months
measure: Total Healthcare Costs
timeFrame: Up to approximately 36 months
measure: Number of Participants Prescribed With Pharmacological Treatments
timeFrame: Up to approximately 36 months
measure: Number of Participants Received Non-Pharmacological Treatments
timeFrame: Up to approximately 36 months
measure: Number of Participants Received Non-Pharmacological Therapy
timeFrame: Up to approximately 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: IQVIA Ltd
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: