Condition category
Ear, Nose and Throat
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
02/12/2010
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

Ms Dunja Nieuwoudt

ORCID ID

Contact details

C/O Research and Effectiveness Department
Level 1 Old Building
Bristol Royal Infirmary
Marlborough Street
Bristol
BS2 8HW
United Kingdom
+44 (0)117 928 3473

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0264167241

Study information

Scientific title

Acronym

Study hypothesis

Which are better, group or individual fittings of hearing aids?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Ear, Nose and Throat: Hearing problems

Intervention

Randomised Controlled Trial:
A: group fitting of hearing aids
B: individual fitting of hearing aids

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Glasgow Hearing Aid Benefit Profile (GHABP)

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/11/2005

Overall trial end date

01/11/2007

Reason abandoned

Eligibility

Participant inclusion criteria

100 participants having hearing aids fitted. 50 in a group setting, 50 individually.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

100

Participant exclusion criteria

Patients who are not suitable for a group fitting eg with poor manual dexterity, poor eye sight, learning difficulties or poor English skills.

Recruitment start date

01/11/2005

Recruitment end date

01/11/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

C/O Research and Effectiveness Department
Bristol
BS2 8HW
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

United Bristol Healthcare NHS Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

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

2009 results presented at 13th British Academic Conference in Otolaryngology and ENT Expo Liverpool, UK (http://onlinelibrary.wiley.com/doi/10.1111/j.1749-4486.2009.01964_2.x/abstract)

Publication citations

Additional files

Editorial Notes