ACT-FLARE study
Research type
Research Study
Full title
ACuTe FLAREs and flare phenotypes in knee osteoarthritis: an observational case-crossover study to improve recognition and advice for prevention and management
IRAS ID
232976
Contact name
George Peat
Contact email
Sponsor organisation
Keele University
Duration of Study in the UK
2 years, 1 months, 16 days
Research summary
Knee osteoarthritis affects approximately 1 in 4 adults from middle age onward and can restrict everyday tasks, including work. Although most people who consult their GP are given information and advice, particularly around weight loss and exercise, patients often lack support and guidance in understanding the behaviour of their symptoms. Evidence suggests that knee pain/osteoarthritis is not experienced the same by everyone but most people experience good days and bad days. Currently there is limited evidence about how people's daily activities relate to unusual increases in pain (flare-ups). Capturing this information as it happens requires novel approaches to faster data collection.
This study aims to recruit 620 participants who have knee pain and/or knee osteoarthritis. Participants will either be recruited through (i) GP practice registers, (ii) through offline advertising (posters, flyers, business cards), (iii) or online advertising (social media) in the local community, within England.
Eligible participants will be provided with access to the ACT-FLARE study web-based interface where they will be asked to give e-Consent. After consenting to take part in the study, participants will be invited to complete a baseline questionnaire.
Following this, all participants will be invited to complete an online questionnaire one week, five weeks, nine weeks and thirteen weeks later. These questionnaires will ask them about their activities on the day of questionnaire completion and the three days before this.
Participants will also be encouraged to notify the research team if and when they experience a flare-up of their knee pain at any point during the 13-week study period. They will then be encouraged to complete an additional online questionnaire. This questionnaire will ask about activities on the day the flare-up started and the three days before this. This will then be followed by a short daily questionnaire until they indicate that their flare-up has resolved.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
18/YH/0075
Date of REC Opinion
28 Feb 2018
REC opinion
Favourable Opinion