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 |
| Protocol serial number | 10049 |
| Sponsor | University of Southampton (UK) |
| Funder | National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (Grant Codes: RP-PG-0407-10098) |
- 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
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
Scientific
Primary Medical Care
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
| seb4@soton.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional; Design type: Diagnosis |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A primary care trial of a tailored interactive website for the self-management of respiratory infections.: a randomised controlled trial |
| Study acronym | Internet Doctor |
| Study objectives | 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(s) | Southampton and South West Hampshire Research Ethics Committee A, 11/03/2011, 11/H0502/10 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
25% reduction in GP visits for RTIs; Timepoint(s): 12 months |
| Key secondary outcome measure(s) |
1. Whether the use of the website alters antibiotic expectations and use |
| Completion date | 31/03/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 2266 |
| Key inclusion criteria | 1. Aged 18 or over 2. Access to the internet |
| Key exclusion criteria | 1. Serious mental health problem 2. Terminal illness 3. Someone from the household is already enrolled on the study |
| Date of first enrolment | 01/10/2011 |
| Date of final enrolment | 31/03/2012 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
SO16 5ST
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
04/05/2016: Publication reference added.
