Effect of supplemental hydrocortisone during stress in prednisolone-induced adrenal insufficiency: a study protocol for a multicentre, randomised, double-blinded, placebo-controlled clinical trial on
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- #adrenal insufficiency
- #polymyalgia rheumatica
- #randomised controlled trial
- Study protocol for RESCUE trial examining supplemental hydrocortisone during stress in patients with PMR/GCA on low-dose prednisolone.
- Primary outcome is health-related quality of life, specifically fatigue measured via smartphone app using ecological momentary assessments.
- Multicentre, randomised, double-blinded, placebo-controlled design with 250 patients randomised and 95 as control group.
- Intervention lasts 6 months or until prednisolone stops, focusing on mild to moderate stress ('sick-days').
- Ethics approved; recruitment started June 2022, with last visit expected in 2026; results will be published.