Condition category
Oral Health
Date applied
14/03/2008
Date assigned
26/03/2008
Last edited
26/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 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.

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

http://www.manchester.ac.uk

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

Publication citations

Additional files

Editorial Notes