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

NCT05137704 | Completed

• 1 other identifier: TAK-489-4005
• Study Type: observational
• Target: 2,236
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Outcome Measures

Primary Outcomes (13)

• Number of General Practitioner (GP) Appointments

  Number of GP appointments will be reported.

  Up to approximately 36 months

• Number of Referrals to Psychiatrist

  Number of referrals to psychiatrist will be reported.

  Up to approximately 36 months

• Number of Referrals by Specialist

  Number of referrals by specialist will be reported.

  Up to approximately 36 months

• Number of Outpatient Visits by Specialist

  Number of outpatient visits by specialist will be reported.

  Up to approximately 36 months

• Number of Investigations Undergone

  Number and type of investigations undergone will be reported.

  Up to approximately 36 months

• Number of Accident and Emergency Visits

  Number of accident and emergency visits will be reported.

  Up to approximately 36 months

• Number of Reasons for Admission

  Number of reasons for admission will be reported.

  Up to approximately 36 months

• Number of Inpatient Hospitalizations

  Number of inpatient hospitalizations will be reported.

  Up to approximately 36 months

• Length of Stay in Hospital

  Length of stay in hospital will be reported.

  Up to approximately 36 months

• Total Healthcare Costs

  Health care cost includes prescription costs, primary health care consultations, investigations, hospital admissions, and outpatient appointments.

  Up to approximately 36 months

• Number of Participants Prescribed With Pharmacological Treatments

  Number of participants prescribed with pharmacological treatment will be reported.

  Up to approximately 36 months

• Number of Participants Received Non-Pharmacological Treatments

  The number of participants who received non-pharmacological treatments will be reported.

  Up to approximately 36 months

• 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

Study Arms (1)

Participant With ADHD

The record available for ADHD participants in primary care-based electronic medical records in the CPRD database linked to secondary care based episodic claims data available in HES database will be assessed.

Other: No intervention

Interventions

No intervention OTHER

This is a non-interventional study.

Participant With ADHD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participant diagnosed with ADHD recorded between 01 January 2016 and 30 June 2018.

You may qualify if:

• 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).
• First record of an adult ADHD diagnosis between 01st January 2016 and 30th June 2018.
• Data availability in the database at least during the 18-months before and after the index date.

You may not qualify if:

• A participant will be excluded from the study if their CPRD linked to HES electronic medical record data includes:
• Incomplete information for key demographics (that is, missing age or sex).
• Clinical history of a diagnosis of ADHD during childhood or adolescence.
• Prescription of a licensed adult ADHD medication (that is, methylphenidate, lisdexamfetamine, dexamfetamine, atomoxetine) during the pre-index period.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

IQVIA Ltd

London, N19JY, United Kingdom

Location

Related Links

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

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: November 30, 2021
• Study Start: December 1, 2021
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: July 12, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

GB (1)