A randomised controlled trial of printed patient information for whiplash patients – is more better?

ISRCTN ISRCTN73891863
DOI https://doi.org/10.1186/ISRCTN73891863
Secondary identifying numbers N/A
Submission date
05/09/2005
Registration date
15/09/2005
Last edited
16/01/2019
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Kim Burton
Scientific

30 Queen Street
Huddersfield
HD1 2SP
United Kingdom

Email kim@spineresearch.org.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeOther
Participant information sheet Not available in web format, contact kim@spineresearch.org.uk to request a patient information sheet
Scientific titleA randomised controlled trial of printed patient information for whiplash patients – is more better?
Study acronymWAD-ED
Study objectivesWhen compared with the control (limited information/advice on a small folded card), the experimental intervention (comprehensive evidence-based information/advice in a 28-page booklet) will improve beliefs about whiplash associated disorder and its consequences, and will increase the proportion of individuals who are self-managing by 3-months post-injury.
Ethics approval(s)Added 09/10/09: Received from the National Research Ethics Service (NRES), Airedale Research Ethics Committee (REC)
Health condition(s) or problem(s) studiedWhiplash associated disorders
Intervention1. Evidence-based patient educational booklet (The Whiplash Book).
2. Small folded card giving llimited information
Intervention typeOther
Primary outcome measureSelf-management of the whiplash associated disorder (i.e. the participant has ceased treatment and feels confident to self-manage their WAD without recourse to further healthcare), a dichotomous outcome measured by a structured questionnaire.
Secondary outcome measures1. Beliefs
2. Disability
3. Pain
Overall study start date01/10/2005
Completion date01/10/2012
Reason abandoned (if study stopped)Lack of funding/sponsorship

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants254
Key inclusion criteria1. Adults attending emergency departments following involvement as a vehicle occupant in a road traffic accident resulting in whiplash associated disorder of Quebec Grade 0 to III. 2. Good understanding of English.
Key exclusion criteria1. Serious spinal pathology, including whiplash injury of Quebec Grade IV.
2. Any clinical conditions (mental or physical) or accident-related injuries that render participation inappropriate.
Date of first enrolment01/10/2005
Date of final enrolment30/09/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

30 Queen Street
Huddersfield
HD1 2SP
United Kingdom

Sponsor information

University of Huddersfield (UK)
University/education

Queensgate
Huddersfield
HD1 2SP
England
United Kingdom

ROR logo "ROR" https://ror.org/05t1h8f27

Funders

Funder type

University/education

University of Huddersfield (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

16/01/2019: Internal review.
14/06/2016: Added trial abandoned due to lack of funding
24/05/2016: No publications found, verifying study status with principal investigator