The Picture Study.
Research type
Research Study
Full title
Understand if a patient’s comprehension of clinical trial information presented during the informed consent process differs when offered in traditional written format or audio-visual presentation in the primary care setting.
IRAS ID
199678
Contact name
Karen McIntyre
Contact email
Duration of Study in the UK
0 years, 5 months, 17 days
Research summary
The research question is to understand if patients’ comprehension of clinical trial information differs when presented as traditional written format or by audio-visual presentation.
The primary aim of this study is to investigate if the presentation of clinical trial information presented graphically versus presentation via written text will enhance patients’ understanding of the clinical trial information. Participants will be presented with study specific information from a study recently completed- Standard of care versus Celecoxib Outcome Trial (SCOT Study). Patients will be randomised (1:1) ratio to receive the study information in either traditional written text or audio-visual format (video). All the information presented in the written PIS has been included in the video and the style has been adapted for narrative communication. Using semi-structured interviews the researcher aims to explore what participants understood about the study and if the media used to present the information influences the desire to participate. To reflect a patient population as close as possible to the SCOT study, purposeful sampling has been selected to intentionally include participants who have similar characteristics, males and females ≥ 60 years of age who have a diagnosis of rheumatoid or osteoarthritis and currently prescribed and have taken Non-Steroidal Anti Inflammatory drugs (NSAIDs) over the previous 12 months. Patient recruitment will take place in a primary care setting. The study will take about 7 months to complete. Each participant will attend only one appointment lasting about between 60 to 90 minutes. Interviews will be conducted with each patient individually to determine their understanding of the information they have been given.Permission has been obtained from the SCOT study research team granted on the 22 September 2015.
The funding of the video by Longboat Clinical is in support of the clinical trial, no data will provided to Longboat clinical.
REC name
South East Scotland REC 02
REC reference
16/SS/0047
Date of REC Opinion
2 Mar 2016
REC opinion
Further Information Favourable Opinion