Condition category
Infections and Infestations
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Ibrahim Abubakar


Contact details

Head TB Section
Health Protection Agency
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Evaluation of information resources: a randomised control study and qualitative review


The NKS- TBP Evaluation Study

Study hypothesis

Tuberculosis is a serious, but treatable infectious disease. About 8,000 new cases of TB are currently reported each year in the United Kingdom (Annual Surveillance report 2006). In 2004 the national action plan "Stopping Tuberculosis in England" set out a strategy for the "reduction and ultimately elimination of TB in the UK". The immediate targets in the action plan are to:
1. Reduce risk of TB
2. Provide high quality treatment for all with TB and
3. Maintain low levels of drug resistance
The first recommendation on how to accomplish these tasks is by "increasing awareness" among healthcare professionals, high risk groups and people who work with them and patients and member of the public. Educational interventions has clearly demonstrated to help General Practitioner's detect tuberculosis in primary care.

The aim of this project is to mobilise current evidence-based guidance and expert opinion to create knowledge and inform decision-making by professionals, carers and the public with regards the recognition and management of tuberculosis (TB).

The National Knowledge Service – Tuberculosis Pilot (NKS–TBP) was set up to provide information that would be directly relevant to people who need to be aware of, and take actions about, the treatment, prevention and management of TB. The target audience are patients, members of the public and healthcare professionals, others with a duty of care.

Information resources have been/are being developed to raise awareness on TB among target groups as identified by members of the NKS–TBP programme board. As the rate of tuberculosis is higher among certain vulnerable groups the NKS–TBP considered that carers who are working closely with these groups should be made targeted in the effort to raise awareness and knowledge of TB in the first instance. This should provide key staff with some guidance on how they can help and support their clients.

This study aims to evaluate a variety of information resources for specific target groups using a multi method approach. The evaluation will determine whether the information has contributed to an in increase in knowledge about TB. The methods to be used for the evaluation include:
1. A qualitative study to explore the opinion of targeted users regarding the benefits of and how best to present these leaflets
2. An observational study using a before and after approach to assess the gain in knowledge
3. A randomised controlled trial to determine whether the leaflets have contributed to a gain in short term knowledge of TB

It is the randomised controlled trial that is the subject of this protocol.

Ethics approval

A formal enquiry was sent to the Camden & Islington Community Local Research Ethics Committee based on the first batch of resources (Homeless sector) produced for this project, which we will be evaluating using the same study design. Application was submitted on the 11th of June 2007 and a reply was received on the 11th of July confirming that this study is an evaluation of a health service and therefore does not require full ethical review.

Study design

Multi-centre randomised controlled trial.

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Tuberculosis (TB)


To detect a 40% increase in knowledge between the two arms with 80% power 5% error, a sample size of 180 participants are required. Randomisation will be undertaken using random numbers generated on the Statistical software Stata by the study team at the Centre for Infections in Colindale. The allocation is then communicated to the head of the relevant organisation for each person to be sent either an intervention or control information resource. The group conducting the study will be blinded to the intervention received by each participant.

The intervention being evaluated is an information leaflet about various aspects of tuberculosis. Resources provided have information on the following:
1. Recognizing the key symptoms, diagnosis and treatment available
2. Client advocacy
3. How to support treatment
4. Referral pathway
5. Risks and precautions for staff
6. Website addresses were further information can be obtained

Participants allocated to the control group will receive a resource which is not on TB, e.g., "mental health and substance mis-use."

The gain in knowledge among participants will be compared using "intention to treat analysis". The ratio of proportional gain in knowledge will be adjusted for previous knowledge and experience of tuberculosis. Knowledge gain will be assessed through before and after questionnaires.

Total duration of intervention: 4 months (from 15th January 2008 to 15th May 2008)

Intervention type



Not Specified

Drug names

Primary outcome measures

Gain in knowledge as measured by the difference in score obtained after the intervention compared to the level before the intervention (questionnaires).

Secondary outcome measures

No secondary outcome measures

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

The main inclusion criterion for qualitative whole study is that individuals must fall within the targeted groups. These groups include:
1. Drug and alcohol mis-users and staff working with them
2. Patient information sheet (pregnancy leaflet)
3. Clinicians (managing pregnant women exposed to TB)
4. Homeless sector staff/managers (TB and homelessness)
5. Staff of the Asylum Seekers
6. Staff taking care of children with TB
7. Prison staff
8. Prisoners (cartoon leaflets on TB)

For the randomised controlled trial component of the study, staff working with drug and alcohol mis-users and asylum seekers will be targeted. Individuals will be invited to participate through emails sent via their organisations mailing list. A sampling frame is available which consists of a list of all individuals employed by each organisation.

Participant type


Age group




Target number of participants


Participant exclusion criteria

Individuals who either do not consent or those who are not in the relevant target group

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Health Protection Agency
United Kingdom

Sponsor information


Health Protection Agency (UK)

Sponsor details

61 Colindale Avenue
United Kingdom

Sponsor type




Funder type


Funder name

Department of Health - The Health Protection Agency (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

2008 results in:

Publication citations

Additional files

Editorial Notes