Contact information
Type
Scientific
Primary contact
Dr Anne-Marie Glenny
ORCID ID
Contact details
School of Dentistry
The University of Manchester
Higher Cambridge Street
Manchester
M15 6FH
United Kingdom
+44 (0)161 275 7811
anne-marie.glenny@manchester.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
TPCS/ethics/07140
Study information
Scientific title
Strategies for maximising consent rates for child dental health surveys: a cluster randomised controlled trial
Acronym
Consent trial
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
University of Manchester Ethics Committee, 05/10/2007, ref: TPCS/ethics/07140
Study design
Cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Schools
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Child dental health
Intervention
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 childs 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 childs 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 childs 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 childs parent/guardian via the child. No further contact will be made.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 measures
The cost of each intervention compared with the control group. This will completed once the study fieldwork is completed.
Overall trial start date
15/09/2007
Overall trial end date
31/07/2008
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
42 schools collecting information from 20 children in each arm, therefore a minimum of 840 children
Participant exclusion criteria
Any child whose parent/legal guardian does not give written informed consent
Recruitment start date
15/09/2007
Recruitment end date
31/07/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The University of Manchester
Manchester
M15 6FH
United Kingdom
Sponsor information
Organisation
The University of Manchester (UK)
Sponsor details
University Research Office
Oxford Road
Manchester
M13 9PL
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
The University of Manchester (UK) - Oral Health Unit
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24006895