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

ISRCTN ISRCTN91518452
DOI https://doi.org/10.1186/ISRCTN91518452
Secondary identifying numbers 10049
Submission date
31/08/2011
Registration date
31/08/2011
Last edited
04/05/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Mrs Susan Broomfield
Scientific

Primary Medical Care
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom

Email seb4@soton.ac.uk

Study information

Study designRandomised; Interventional; Design type: Diagnosis
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA primary care trial of a tailored interactive website for the self-management of respiratory infections.: a randomised controlled trial
Study acronymInternet Doctor
Study objectivesThis 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 patient’s information on RTIs and influenza like illnesses (ILIs) will be collected, along with doctor’s 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(s)Southampton and South West Hampshire Research Ethics Committee A, 11/03/2011, 11/H0502/10
Health condition(s) or problem(s) studiedTopic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases
Intervention1. 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 typeOther
Primary outcome measure25% reduction in GP visits for RTIs; Timepoint(s): 12 months
Secondary outcome measures1. Whether the use of the website alters antibiotic expectations and use
2. The cost effectiveness of the website
Overall study start date01/10/2011
Completion date31/03/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned Sample Size: 2266; UK Sample Size: 2266
Key inclusion criteria1. Aged 18 or over
2. Access to the internet
Key exclusion criteria1. Serious mental health problem
2. Terminal illness
3. Someone from the household is already enrolled on the study
Date of first enrolment01/10/2011
Date of final enrolment31/03/2012

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Aldermoor Health Centre
Southampton
SO16 5ST
United Kingdom

Sponsor information

University of Southampton (UK)
University/education

Primary Medical Care
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
England
United Kingdom

Email notprovided@email.com
ROR logo "ROR" https://ror.org/01ryk1543

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (Grant Codes: RP-PG-0407-10098)
Government organisation / National government
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 20/04/2016 Yes No

Editorial Notes

04/05/2016: Publication reference added.