ISRCTN - ISRCTN91518452: A primary care trial of a tailored interactive website for the self-management of respiratory infections.

Plain English Summary

Background and study aims
Many people with respiratory illnesses such as coughs, colds, influenza, sore throats or sinusitis go to see their general practitioner (GP), taking up large amounts of time and NHS resources. The majority of these illnesses do not require treatment and will get better on their own. However, people go to their doctor because they do not have good information about how long these illnesses normally last or how severe the symptoms can be. The study aims to improve the information made available to patients about how they can manage these illnesses without visiting their doctor and also when they should seek medical advice.

Who can participate?
Participants need to be over the age of 18, have no serious mental health problems, have access to the internet and be the only person from their household taking part in the study.

What does the study involve?
Recruitment will be through letters sent out by GPs inviting people to take part in the study. Participants will be placed randomly into one of two groups (treatment and control). Both groups will be asked to complete monthly online questionnaires about any respiratory illnesses they have. The treatment group will have immediate access to an interactive website which will give them advice about how to manage their illness based on the answers they give to questions asked by the website. The control group will be allowed to use the website when the study has ended. A small number of people from the treatment group will be interviewed to find out what they think about the website. A review of the relevant parts of the patient's notes will be carried out six months after the end of the study for both groups.

What are the possible benefits and risks of participating?
Participants may find that they are more able to cope with respiratory illnesses without consulting their GP and be more aware of symptoms that indicate when they should seek medical advice. There is a very slight risk that patients may not seek medical advice for a serious illness; however, the questions on the website have been developed by experts to ensure patients are given clear instructions about when they should consult a health professional.

Where is the study run from?
The study is being run by Primary Medical Care, University of Southampton (UK)

When is the study starting and how long will it run for?
The study is hoping to recruit about 2300 people from October 2011 through to Spring 2012. Recruits will be in the study for six months but the review of their notes will take place 12 months after they are recruited.

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Mrs Susan Broomfield (Study Manager)
seb4@soton.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Susan Broomfield

ORCID ID

Contact details

Primary Medical Care
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
-
seb4@soton.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

10049

Study information

Scientific title

A primary care trial of a tailored interactive website for the self-management of respiratory infections.: a randomised controlled trial

Acronym

Internet Doctor

Study hypothesis

This study will be trialling a theoretically-based website providing interactive and personalised advice on:
1. Whether and why the patient needs/does not need to consult the general practitioner (GP)
2. How to self-care for respiratory tract infections (RTIs) and manage concerns. The study will recruit a minimum of 2266 patients to the website through their primary care network. During the trial patients information on RTIs and influenza like illnesses (ILIs) will be collected, along with doctors notes for visits and treatment. The study will provide evidence on the cost-effectiveness of using a web-intervention to alleviate the drain on primary care resources.

Ethics approval

Southampton and South West Hampshire Research Ethics Committee A, 11/03/2011, 11/H0502/10

Study design

Randomised; Interventional; Design type: Diagnosis

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

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

Condition

Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases

Intervention

1. Baseline: Participants complete online questionnaires prior to randomisation
2. End of Study: Participants complete online questionnaires
3. Monthly questionnaires: Patients asked to report RTIs in previous month (both groups)
4. Use of website: Treatment arm log on if they have an RTI to report symptoms and access Internet Doctor

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measure

25% reduction in GP visits for RTIs; Timepoint(s): 12 months

Secondary outcome measures

1. Whether the use of the website alters antibiotic expectations and use
2. The cost effectiveness of the website

Overall trial start date

01/10/2011

Overall trial end date

31/03/2012

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18 or over
2. Access to the internet

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 2266; UK Sample Size: 2266

Participant exclusion criteria

1. Serious mental health problem
2. Terminal illness
3. Someone from the household is already enrolled on the study

Recruitment start date

01/10/2011

Recruitment end date

31/03/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Aldermoor Health Centre
Southampton
SO16 5ST
United Kingdom

Sponsor information

Organisation

University of Southampton (UK)

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (Grant Codes: RP-PG-0407-10098)