Attention Deficit Hyperactivity Disorder (ADHD)NCT05137704
A Study on the Use of Healthcare Resources and Costs of Attention Deficit Hyperactivity Disorder (ADHD) in Adults in England
An observational study of Attention Deficit Hyperactivity Disorder (ADHD), run by Takeda at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD)
- How many people
- 2,236 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2021to 31 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participant diagnosed with ADHD recorded between 01 January 2016 and 30 June 2018.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Healthcare Resources Utilization and Associated Costs of Adult ADHD in England
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.
- Being tested
- No intervention
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is a non-interventional study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of General Practitioner (GP) Appointments
Number of GP appointments will be reported.
Measured: Up to approximately 36 months
Number of Referrals to Psychiatrist
Number of referrals to psychiatrist will be reported.
Measured: Up to approximately 36 months
Number of Referrals by Specialist
Number of referrals by specialist will be reported.
Measured: Up to approximately 36 months
Number of Outpatient Visits by Specialist
Number of outpatient visits by specialist will be reported.
Measured: Up to approximately 36 months
Number of Investigations Undergone
Number and type of investigations undergone will be reported.
Measured: Up to approximately 36 months
Number of Accident and Emergency Visits
Number of accident and emergency visits will be reported.
Measured: Up to approximately 36 months
Number of Reasons for Admission
Number of reasons for admission will be reported.
Measured: Up to approximately 36 months
Number of Inpatient Hospitalizations
Number of inpatient hospitalizations will be reported.
Measured: Up to approximately 36 months
Length of Stay in Hospital
Length of stay in hospital will be reported.
Measured: Up to approximately 36 months
Total Healthcare Costs
Health care cost includes prescription costs, primary health care consultations, investigations, hospital admissions, and outpatient appointments.
Measured: Up to approximately 36 months
Number of Participants Prescribed With Pharmacological Treatments
Number of participants prescribed with pharmacological treatment will be reported.
Measured: Up to approximately 36 months
Number of Participants Received Non-Pharmacological Treatments
The number of participants who received non-pharmacological treatments will be reported.
Measured: 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.
Measured: Up to approximately 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start1 Dec 2021
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05137704
- Sponsor's protocol ID
- TAK-489-4005
- Status last verified
- Jul 2022
- First submitted
- 25 Nov 2021
- Last updated
- 12 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthcare Resources Utilization and Associated Costs of Adult ADHD in England
- ClinicalTrials.gov ID
- NCT05137704
- Acronym / sponsor ID
- TAK-489-4005
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,236 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 30 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participant With ADHD | – | Other: No interventionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participant diagnosed with ADHD recorded between 01 January 2016 and 30 June 2018.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis is a non-interventional study. | Other | Participant With ADHD |
Primary outcome
Number of General Practitioner (GP) Appointments
Time frame: Up to approximately 36 months
Number of GP appointments will be reported.
Number of Referrals to Psychiatrist
Time frame: Up to approximately 36 months
Number of referrals to psychiatrist will be reported.
Number of Referrals by Specialist
Time frame: Up to approximately 36 months
Number of referrals by specialist will be reported.
Number of Outpatient Visits by Specialist
Time frame: Up to approximately 36 months
Number of outpatient visits by specialist will be reported.
Number of Investigations Undergone
Time frame: Up to approximately 36 months
Number and type of investigations undergone will be reported.
Number of Accident and Emergency Visits
Time frame: Up to approximately 36 months
Number of accident and emergency visits will be reported.
Number of Reasons for Admission
Time frame: Up to approximately 36 months
Number of reasons for admission will be reported.
Number of Inpatient Hospitalizations
Time frame: Up to approximately 36 months
Number of inpatient hospitalizations will be reported.
Length of Stay in Hospital
Time frame: Up to approximately 36 months
Length of stay in hospital will be reported.
Total Healthcare Costs
Time frame: Up to approximately 36 months
Health care cost includes prescription costs, primary health care consultations, investigations, hospital admissions, and outpatient appointments.
Number of Participants Prescribed With Pharmacological Treatments
Time frame: Up to approximately 36 months
Number of participants prescribed with pharmacological treatment will be reported.
Number of Participants Received Non-Pharmacological Treatments
Time frame: Up to approximately 36 months
The number of participants who received non-pharmacological treatments will be reported.
Number of Participants Received Non-Pharmacological Therapy
Time frame: Up to approximately 36 months
The non-pharmacological therapy will be cognitive behavioural therapy. Number of participants who received non-pharmacological therapy will be reported.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- To obtain more information on the study, click here/on this linkLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Related trials for Attention Deficit Hyperactivity Disorder (ADHD)
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Hyperactivity Disorder (ADHD), run by Takeda at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of General Practitioner (GP) Appointments (time frame: Up to approximately 36 months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2022.