Condition category
Not Applicable
Date applied
17/05/2013
Date assigned
17/05/2013
Last edited
14/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The internet has seen an explosion of websites featuring people’s accounts of their experiences of health and illness, for example through blogs, patients forums, online ratings sites and voluntary organisation websites. These are popular, but may cause harm as well as benefits. The aim of this study is to find out whether or not people find health information websites useful and if so, how best to provide health information online. Information from health websites may help people make better healthcare choices, alert them to health issues and improve their understanding. By conducting this study we hope to learn more about how people use health information websites, whether information is more useful if it is presented in a particular way, and if people have a preference as to how health information is provided online.

Who can participate?
For this study we want to recruit people who are in one of three categories:
1. People with asthma
2. People who smoke but are thinking of quitting
3. People who are carers of someone who has multiple sclerosis.
If one of these categories applies to you then you may be eligible to take part. If you are over 18, have an email address, access to an internet connection and are willing to answer some questions online, we would like to hear from you.

What does the study involve?
Participants are asked to look at a health information website. Before viewing the website we ask them to complete some questionnaires about their health and their attitude to health information on the internet. These questions should take no more than 10 minutes to complete. Once they have answered these questions they are able to create a username and a password and are given access to a health information website. They have two weeks to access the website during which time we would like them to visit the website as many times as they wish and look at whatever information is of particular interest. They can select ‘Comment on page’ to tell us what they think about the website or leave any comments about the study; they can also rate individual web pages. After two weeks we ask them to answer some further questions about their health and also their views on the website they looked at. These questions should take no more than 10 minutes to complete. When they are using the health information website we will monitor which particular pages they view. We will also look at whether they use the search facility to find information and what search words they enter. We also invite some (but not all) participants for an interview. This interview is conducted in person by someone visiting their home, or another suitable location. The interview is entirely voluntary.

What are the possible benefits and risks of participating?
We cannot guarantee that participants will personally benefit from this study but you will be contributing to important research. We do not foresee any major risks to taking part in this study but if any of the information you come across on the website causes you concern about your health (or the health of someone you care for) please contact your GP or call NHS Direct.The information you provide via the online questionnaires and website visits will be analysed anonymously.

Where is the study run from?
University of Oxford (UK).

When is the study starting and how long is it expected to run for?
June 2013 to May 2014.

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

Who is the main contact?
Prof. John Powell
expert@phc.ox.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof John Powell

ORCID ID

http://orcid.org/0000-0002-1456-4857

Contact details

Nuffield Department of Primary Care Health Sciences
University of Oxford
Gibson Building 1st Floor
Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom
-
expert@phc.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

14521

Study information

Scientific title

EXPerience of a health website Evaluated in a Research Study: An exploratory study to assess feasibility, and measure the impact of online health information (experiential and fact-based) for self-management of asthma, motivation to stop smoking and preparedness for caring for someone with multiple sclerosis

Acronym

EXPERT

Study hypothesis

EXPERT is a randomised, controlled trial in which we are comparing the effects of online interventions (websites) offered to people with one of three conditions (people with asthma; people who smoke but want to quit; and carers of people with Multiple Sclerosis). We are studying whether information from different sources can help self-management of illness; help achieve health behaviour change and help people feel more supported in their caring role.

Ethics approval

First MREC approval date 27/02/2013, ref: 0162

Study design

Interventional randomised controlled trial; Design type: feasibility

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 contact details to request a participant information sheet

Condition

Smoking cessation, management of chronic asthma, caring for a person with multiple sclerosis

Intervention

All eligible participants are sent a patient information sheet and asked to provide baseline measures prior to their website allocation. Once the participant submitted their questionnaire responses (baseline data) by clicking ‘finish’ they were randomised into the study and allocated to a website. Randomisation was carried out by stratified (on the three conditions) block randomisation with varying block sizes. Participants were randomised in a 1:1 ratio to either the intervention or comparator websites in each of the three study conditions. A randomisation list was generated and uploaded to the web-based system to ensure treatment concealment. The investigators were not aware of the randomisation result on the system. The randomisation list, which was password protected, was kept in confidence. Participants create a unique user ID and password which allows unlimited website access for two weeks. Participants’ website use is tracked in full. After two weeks, participants will be asked to provide follow up measures and website access will be removed. A selection of participants will be invited for interview after completion of the study.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

To evaluate the feasibility issues in an online randomised study providing health information websites containing patient experience information compared with matched health information websites that do not contain experiential information.

Secondary outcome measures

1. To assess the efficacy of two types of online health information (patient experience accounts compared with matched health information websites that do not contain experiential information) on a range of self-reported outcomes
2. To explore whether the interventions have differential effects on pre-specified subgroups of participants
3. To measure the impact of the intervention and comparator websites using the eHealth Impact Questionnaire (eHIQ)

Overall trial start date

03/06/2013

Overall trial end date

31/05/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Smokers:
1. People who are current smokers, who have been smokers for at least a year, and who indicate some willingness to quit, including those referred to smoking cessation services
2. Male or female aged 18 or over
3. Willing and able to give informed consent for participation in the study
4. Live in England
5. Have access to the internet and able to use websites

People with asthma:
1. People who have been clinically diagnosed with asthma as coded in their primary care electronic record, and who have been prescribed inhaled corticosteroids for at least 3 months in the previous year
2. Male or female aged 18 or over
3. Willing and able to give informed consent for participation in the study
4. Live in England
5. Have access to the internet and able to use websites

Carers of people with multiple sclerosis:
1. People who identify themselves as a caregiver for another person who has a diagnosis of multiple sclerosis
2. Male or female aged 18 or over
3. Willing and able to give informed consent for participation in the study
4. Live in England
5. Have access to the internet and able to use websites

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

UK Sample Size: 300

Participant exclusion criteria

Smokers:
1. People who are terminally ill
2. People who cannot understand English
3. People who have previously entered the study
4. People who have another significant disease or disorder which, in the opinion of the GP, may either put that person at risk because of participation in the study, or may influence the result of the study, or affect that person's ability to participate in the study

People with asthma:
1. People who are terminally ill
2. People who cannot understand English
3. People who have previously entered the study
4. People who have another significant disease or disorder which, in the opinion of the GP, may either put that person at risk because of participation in the study, or may influence the result of the study, or affect that person's ability to participate in the study

Carers of people with multiple sclerosis:
1. People who are terminally ill
2. People who cannot understand English
3. People who have previously entered the study
4. People who have a significant disease or disorder which, in the opinion of the Principal Investigator, may either put that person at risk because of participation in the study, or may influence the result of the study, or affect that person's ability to participate in the study
5. People whose only caring role is in a professional (paid) capacity

Recruitment start date

14/06/2013

Recruitment end date

31/08/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Nuffield Department of Primary Care Health Sciences
University of Oxford Gibson Building 1st Floor Radcliffe Observatory Quarter Woodstock Road
Oxford
OX2 6GG
United Kingdom

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

Churchill Hospital
Old Road
Oxford
OX1 2JD
United Kingdom

Sponsor type

University/education

Website

http://www.ox.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK)

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Once we have completed our statistical analysis, and know whether there is any evidence of benefit, we will make some of the content of the study websites freely available on the internet. The results will also published in a scientific journal, through reports and conference presentations as well as on our website.

Intention to publish date

01/12/2015

Participant level data

Available on request

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27835953

Publication citations

Additional files

Editorial Notes

14/11/2016: Publication reference added. 22/10/2015: The overall trial end date was changed from 31/05/2014 to 24/10/2014.