Mineralocorticoid treatment and quality of life in primary adrenal insufficiency
OA Version
Citation
Abstract
BACKGROUND: Patients with Primary Adrenal Insufficiency (PAI) report reduced quality of life. The existing research on clinical outcomes in patients with PAI has primarily focused on glucocorticoid (GC) replacement with inadequate analysis of outcomes related to fludrocortisone treatment (mineralocorticoid management). The aim of this study is to implement a nonpharmacologic intervention associated with fludrocortisone replacement to improve Health-Related Quality of Life (HRQOL).
PROPOSED PROJECT: The study would include 320 participants with newly diagnosed PAI divided into two groups: experimental and control. Each group will receive standardized pharmacologic GC and MC treatment using a standardized algorithm for a three-month run-in period. The experimental group will receive a standardized educational video describing non-pharmaceutical techniques to manage salt/water intake in specific situations, such as during exercise or hot weather. Each group will complete the specific quality of life in Addison’s disease questionnaire (AddiQOL) at designated intervals. With a study population of 320, randomized into two groups of 160, the study will be powered to 80% to detect a standardized effect of 0.3. This constitutes an effective size of small to medium using Cohn’s kappa, signifying that a difference will be detected if there is one.
CONCLUSIONS: This study will assess whether an intervention aimed at strengthening patients’ knowledge regarding nonpharmacologic methods to augment their MC management can improve HRQOL as assessed by AddiQOL.
Description
2024