|
ISRCTN
|
ISRCTN16261913
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Strategies for maximising consent rates for child dental health surveys: a cluster randomised controlled trial
|
|
Scientific title
|
|
|
Acronym
|
Consent trial
|
|
Serial number at source
|
TPCS/ethics/07140
|
|
Study hypothesis
|
Working hypothesis:
To test the null hypothesis that there is no difference in consent rates between strategies used for recruiting participants to child dental health surveys, against the alternative working hypothesis of a difference.
|
|
Ethics approval
|
Ethics approval received by the University of Manchester Ethics Committee on the 5th October 2007 (ref: TPCS/ethics/07140)
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Child dental health
|
|
Participants - inclusion criteria
|
The inclusion criteria for the randomised controlled trial (RCT) will be any school, with 20 or more five year old children selected for the annual British Association for the Study of Community Dentistry (BASCD) survey in the following Primary Care Trusts (PCTs):
1. Halton and St Helens PCT
2. Warrington PCT
3. Western Cheshire PCT
4. Knowsley PCT
5. Liverpool PCT
6. Blackburn and Darwen Teaching PCT
|
|
Participants - exclusion criteria
|
Any child whose parent/legal guardian does not give written informed consent
|
|
Anticipated start date
|
15/09/2007
|
|
Anticipated end date
|
31/07/2008
|
|
Status of trial
|
Completed |
|
Patient information material
|
Not available in web format, please use the contact details below to request a patient information sheet
|
|
Target number of participants
|
42 schools collecting information from 20 children in each arm, therefore a minimum of 840 children
|
|
Interventions
|
Financial incentive one and postage:
Each school will be provided with stamped, named envelopes, containing a standard information leaflet and standard consent form, to be addressed by the school and posted to the parents of the selected children. The parents will be asked to return the consent form to the school. In each school the person responsible for the management of the consent letters will receive a £50 Marks and Spencers (M&S) voucher if the school achieve a consent rate of 75% or above.
Financial incentive two:
Named envelopes, containing the standard consent form and standard information leaflet for each child selected to be surveyed, will be distributed by the school and sent to the child’s parent/guardian via the child. Each school will be given £4.00 for each selected child whose parents consent to the survey.
Additional information:
The head of each school will be provided with information about the importance of oral health and the dental survey, to be presented at a school assembly. In addition each parent will be given a ‘glossy leaflet’ about the importance of oral health along with the standard consent form and standard information leaflet, to be distributed via the children.
Multiple letters:
Named envelopes, containing the standard consent form and standard information leaflet for each child selected to be surveyed, will be distributed by the school and sent to the child’s parent/guardian via the child. Two weeks after the consent forms are sent the school will be contacted to find out how many have been returned. A second letter will be prepared for non-responders and sent to the school for distribution. This letter is again in an envelope and addressed to the child’s parent/guardian. One to two weeks later the school will be contacted again to find out how many forms have been returned and get the names of the non-responders. Local advice from the school will be taken with regard to the remaining non-responders.
Control arm:
Named envelopes, containing the standard consent form and standard information leaflet for each child selected to be surveyed, will be distributed by the school and sent to the child’s parent/guardian via the child. No further contact will be made.
|
|
Primary outcome measure(s)
|
The main outcome of interest will be the consent rate, by school, on the day of dental examination, measured once the dental examination is completed. A health economic evaluation will also be undertaken.
|
|
Secondary outcome measure(s)
|
The cost of each intervention compared with the control group. This will completed once the study fieldwork is completed.
|
|
Sources of funding
|
The University of Manchester (UK) - Oral Health Unit
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Anne-Marie
Glenny
|
|
Address
|
School of Dentistry
The University of Manchester
Higher Cambridge Street
|
|
City/town
|
Manchester
|
|
Zip/Postcode
|
M15 6FH
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)161 275 7811
|
|
Email
|
anne-marie.glenny@manchester.ac.uk
|
|
Sponsor
|
The University of Manchester (UK)
|
|
Address
|
University Research Office
Oxford Road
|
|
City/town
|
Manchester
|
|
Zip/Postcode
|
M13 9PL
|
|
Country
|
United Kingdom
|
|
Sponsor website:
|
http://www.manchester.ac.uk
|
|
Date applied
|
14/03/2008
|
|
Last edited
|
26/03/2008
|
|
Date ISRCTN assigned
|
26/03/2008
|
