An enhanced participant information leaflet and multimedia intervention to improve the quality of informed consent to a randomised clinical trial enrolling people living with HIV and obesity: a protocol for a Study Within A Trial (SWAT).
Lydia O' SullivanStefano SavinelliStephen O'HareSinéad HoldenCiara McHughPatrick MallonPeter DoranPublished in: Trials (2022)
ClinicalTrials.gov NCT04174755 . EudraCT 2019-002314-39. SWAT 160, Northern Ireland Hub for Trials Methodology Research SWAT repository (Clarke M, et al., Trials. 16:P209, 2015).
Keyphrases
- clinical trial
- study protocol
- randomized controlled trial
- phase ii
- open label
- phase iii
- double blind
- metabolic syndrome
- weight loss
- insulin resistance
- mitral valve
- type diabetes
- aortic valve
- weight gain
- high fat diet induced
- placebo controlled
- healthcare
- quality improvement
- heart failure
- health information
- body mass index
- network analysis
- left ventricular
- social media