Strategies for maximising consent rates for child dental health surveys: a cluster randomised controlled trial

ISRCTN	ISRCTN16261913
DOI	https://doi.org/10.1186/ISRCTN16261913
Secondary identifying numbers	TPCS/ethics/07140

Submission date: 14/03/2008
Registration date: 26/03/2008
Last edited: 26/11/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Anne-Marie Glenny
Scientific

School of Dentistry
The University of Manchester
Higher Cambridge Street
Manchester
M15 6FH
United Kingdom

Phone	+44 (0)161 275 7811
Email	anne-marie.glenny@manchester.ac.uk

Study information

Study design	Cluster randomised controlled trial
Primary study design	Interventional
Secondary study design	Cluster randomised trial
Study setting(s)	School
Study type	Other
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Strategies for maximising consent rates for child dental health surveys: a cluster randomised controlled trial
Study acronym	Consent trial
Study objectives	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(s)	University of Manchester Ethics Committee, 05/10/2007, ref: TPCS/ethics/07140
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	15/09/2007
Completion date	31/07/2008

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	5 Years
Upper age limit	5 Years
Sex	Both
Target number of participants	42 schools collecting information from 20 children in each arm, therefore a minimum of 840 children
Key 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
Key exclusion criteria	Any child whose parent/legal guardian does not give written informed consent
Date of first enrolment	15/09/2007
Date of final enrolment	31/07/2008

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

The University of Manchester

Manchester
M15 6FH
United Kingdom

Sponsor information

The University of Manchester (UK)
University/education

University Research Office
Oxford Road
Manchester
M13 9PL
England
United Kingdom

Website	http://www.manchester.ac.uk
"ROR"	https://ror.org/027m9bs27

Funders

Funder type

University/education

The University of Manchester (UK) - Oral Health Unit

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	04/09/2013		Yes	No