The use of audio tapes in oral health promotion for an Urdu-speaking community
| ISRCTN | ISRCTN28602629 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28602629 |
| Secondary identifying numbers | RBF 99X23 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 11/06/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
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
Ms Rosemarie Khan
Scientific
Scientific
Community Dental Service
Community Health Sheffield NHS Trust
Fulwood House
Old Fulwood Road
Sheffield
S10 3TH
United Kingdom
| Phone | +44 (0)114 272 8802 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | Primary research question: does the use of pre-recorded audio tapes encourage patients to complete their course of dental treatment? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Oral health |
| Intervention | 1. Exposure to audio tapes 2. Standard care |
| Intervention type | Other |
| Primary outcome measure | The intervention will be considered effective if it reduces the failure rate by 20-40%. To have an 80% power of detecting such a difference as statistically significant at the 5% two-sided level could required 107 children per group (214 in total). This service sees approximately 150 patients per month in this age group. Assuming 60% agree to take part, then to recruit 214 children will take approximately 3 months. The main outcome measure is the difference in the failure rate between the two groups (intervention and control); failures to attend for appointments will be compared by a Chi squared test. 95% confidence intervals for the differences in failures to attend for appointments between the two groups will also be calculated. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 27/09/1999 |
| Completion date | 01/09/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 10 Years |
| Sex | Both |
| Target number of participants | 214 |
| Key inclusion criteria | The age group will be 6-10 Sample size: the main outcome for determining sample size is failure rate. The current failure rate is approximately 60%. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 27/09/1999 |
| Date of final enrolment | 01/09/2001 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Community Dental Service
Sheffield
S10 3TH
United Kingdom
S10 3TH
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive Trent (UK)
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 |
