ISRCTN ISRCTN45400501
DOI https://doi.org/10.1186/ISRCTN45400501
IRAS number 257567
Secondary identifying numbers IRAS number 257567
Submission date
27/08/2019
Registration date
29/08/2019
Last edited
14/12/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Attention Deficit Hyperactive Disorder (ADHD) is a developmental disorder affecting up to 5% of the population. ADHD is underdiagnosed in the UK and the process of accessing care is complex and variable. The care pathway usually involves General practitioners (GPs) referring patients to secondary care for a diagnosis and treatment. It is therefore essential that GPs have a clear understanding of ADHD and associated care pathways in order to provide optimal care for patients. This study aims to evaluate the efficiency and usability of an ADHD online education program for GPs

Who can participate?
GPs and GP trainees from England can participate in this study

What does the study involve?
This study involves GPs taking part in an online education program aimed to increase their awareness and understanding of ADHD. Following a randomised parallel design, the participants will be randomised into two groups, an intervention group and a control group. The intervention group will view the online intervention shortly after consenting to take part in the study while the control group will not view the online program upon taking part but will be invited to view it at a later date. Both groups will complete the same questionnaire on ADHD awareness at three time points, baseline, straight after completion of the intervention/control and 2 weeks after

What are the possible benefits and risks of participating?
Participants will gain a greater understanding of ADHD which in turn will facilitate their practice and help their patients. No risks are anticipated from taking part in this study

Where is the study run from?
The study is run from the University of Nottingham but as this is an online program, it can be accessed from anywhere in the country. All Clinical Research Networks (CRN) in England have agreed to take part, representing a national sample

When is the study starting and how long is it expected to run for?
The recruitment for this study takes place from July 2019 until August 2019. Participants are invited to take part in the study from September 2019

Who is funding the study?
This study is funded by the Economic and Social Research Council (ESRC) as part of a DTC PhD project

Who is the main contact?
The main contact is Blandine French
blandine.french@nottingham.ac.uk

Study website

Contact information

Mrs Blandine French
Public

Room B15, Yang Fujiya building
Jubilee campus
University of Nottingham
Nottingham
NG8 1BB
United Kingdom

ORCiD logoORCID ID 0000-0002-9395-5919
Phone 0115 823 0261
Email blandine.french@nottingham.ac.uk
Mrs Blandine French
Scientific

Room B15, Yang Fujiya building
Jubilee campus
University of Nottingham
Nottingham
NG8 1BB
United Kingdom

ORCiD logoORCID ID 0000-0002-9395-5919
Phone 0115 823 0261
Email blandine.french@nottingham.ac.uk

Study information

Study designPilot randomised controlled trial with waitlist control
Primary study designInterventional
Secondary study designRandomised parallel trial
Study setting(s)GP practice
Study typeDiagnostic
Participant information sheet https://nottingham.onlinesurveys.ac.uk/information-sheet
Scientific titleAssessing the effectiveness of an online ADHD awareness online resource in primary care: Pilot of a randomised control trial evaluation
Study objectivesThe purpose of this study is to explore the efficiency of an online ADHD awareness intervention for GPs. We hypothise that GPs will have a better awareness and understadning of ADHD after taking part in a short online psychoeducation program
Ethics approval(s)1. Approved 20/02/2019, HRA (Health Research Authority, 3rd Floor Barlow House, Minshull Street, Manchester, M1 3DZ; +44207 104 8193; Hra.approval@nhs.net), ref: IRAS ID 257567
2. Approved 10/04/2019, Faculty of Medicine and Health Science Research Ethics Committee from the University of Nottingham (East Atrium, Jubilee Conference Centre, Jubilee Campus, Nottingham, NG8 1DH; +44115 8467906; sponsor@nottingham.ac.uk), ref: 270-1902, RGS ref: 19002
Health condition(s) or problem(s) studiedAttention Deficit Hyperactivity Disorder (ADHD)
InterventionThe participants will be randomly allocated to two groups: intervention or a waitlist control group (no treatment). A simple randomisation process will determine which group each participant is allocated to by generating a random number to create a random allocation sequence.

After receiving written consent from the participants, they will be invited to take part in the study. Participants will be advised that the study will last around 60 minutes. After randomisation, participants will be allocated to either the intervention or control group. Both groups will complete the same questionnaire at three time points, baseline, straight after completion of the intervention/control and 2 weeks post-intervention. The intervention group will take part in a 45-minute online psycho-education program on ADHD. The control group will be given a 25-minute video to watch and will be invited to view the intervention after completing the last questionnaire.
Intervention typeMixed
Primary outcome measureADHD awareness and knowledge measured using a questionnaire (an adapted version of the KADDS (Scuitto et al, 2000) and Adamis et al., 2019) pre and post-intervention
Secondary outcome measures1. Perceived confidence in the knowledge of ADHD measured using a questionnaire (an adapted version of the KADDS (Scuitto et al, 2000) and Adamis et al., 2019) pre and post-intervention
2. Beliefs and attitudes towards ADHD measured using a questionnaire (an adapted version of the KADDS (Scuitto et al, 2000) and Adamis et al., 2019) pre and post-intervention
Overall study start date01/09/2018
Completion date01/07/2020

Eligibility

Participant type(s)Health professional
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants150
Total final enrolment235
Key inclusion criteria1. Aged 18 or above
2. General practitioners in NHS primary care setting in England, or
3. GP trainees/ registrar in their last 3 years of training
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment10/07/2019
Date of final enrolment01/09/2019

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of Nottingham
Nottingham
NG8 1BB
United Kingdom

Sponsor information

University of Nottingham
University/education

Research and Innovation
East Atrium
Jubilee Conference Centre
Triumph Road
Nottingham
NG8 1DH
England
United Kingdom

Phone 01158467103
Email BB-sponsor@exmail.nottingham.ac.uk
Website http://www.nottingham.ac.uk/
ROR logo "ROR" https://ror.org/01ee9ar58

Funders

Funder type

Research council

Economic and Social Research Council
Government organisation / National government
Alternative name(s)
ESRC
Location
United Kingdom

Results and Publications

Intention to publish date01/09/2020
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planThis study is part of a PhD project and will be written up as a chapter of the final PhD thesis. This study will also be published on its own as an academic paper, expected submission by August 2020
IPD sharing planThe current data sharing plans for this study are unknown and will be available at a later date

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 11/12/2020 14/12/2020 Yes No

Editorial Notes

14/12/2020: Publication reference added.
05/03/2020: The intention to publish date was changed from 01/09/2019 to 01/09/2020.
17/01/2020: Internal review.
04/10/2019: The total final enrolment was added.
28/08/2019: Trial’s existence confirmed by Faculty of Medicine and Health Science Research Ethics Committee from the University of Nottingham.