A Study on the Use of Healthcare Resources and Costs of Attention Deficit Hyperactivity Disorder (ADHD) in Adults in England

Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial

Official title:

Healthcare Resources Utilization and Associated Costs of Adult ADHD in England

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05137704
• Other study ID #: TAK-489-4005
• Status: Completed
• Start date: December 1, 2021
• Est. completion date: March 31, 2022

Study information

• Verified date: July 2022
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2236
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder (ADHD)
• Hyperkinesis

Intervention

Other:
• No intervention
This is a non-interventional study.

Locations

Country	Name	City	State
United Kingdom	IQVIA Ltd	London

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of General Practitioner (GP) Appointments	Number of GP appointments will be reported.	Up to approximately 36 months
Primary	Number of Referrals to Psychiatrist	Number of referrals to psychiatrist will be reported.	Up to approximately 36 months
Primary	Number of Referrals by Specialist	Number of referrals by specialist will be reported.	Up to approximately 36 months
Primary	Number of Outpatient Visits by Specialist	Number of outpatient visits by specialist will be reported.	Up to approximately 36 months
Primary	Number of Investigations Undergone	Number and type of investigations undergone will be reported.	Up to approximately 36 months
Primary	Number of Accident and Emergency Visits	Number of accident and emergency visits will be reported.	Up to approximately 36 months
Primary	Number of Reasons for Admission	Number of reasons for admission will be reported.	Up to approximately 36 months
Primary	Number of Inpatient Hospitalizations	Number of inpatient hospitalizations will be reported.	Up to approximately 36 months
Primary	Length of Stay in Hospital	Length of stay in hospital will be reported.	Up to approximately 36 months
Primary	Total Healthcare Costs	Health care cost includes prescription costs, primary health care consultations, investigations, hospital admissions, and outpatient appointments.	Up to approximately 36 months
Primary	Number of Participants Prescribed With Pharmacological Treatments	Number of participants prescribed with pharmacological treatment will be reported.	Up to approximately 36 months
Primary	Number of Participants Received Non-Pharmacological Treatments	The number of participants who received non-pharmacological treatments will be reported.	Up to approximately 36 months
Primary	Number of Participants Received Non-Pharmacological Therapy	The non-pharmacological therapy will be cognitive behavioural therapy. Number of participants who received non-pharmacological therapy will be reported.	Up to approximately 36 months

External Links

•   To obtain more information on the study, click here/on this link