Forskning
Udskriv Udskriv
Switch language
Region Hovedstaden - en del af Københavns Universitetshospital
Udgivet

PlenadrEMA: effect of dual-release versus conventional hydrocortisone on fatigue, measured by ecological momentary assessments: a study protocol for an open-label switch pilot study

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

DOI

  1. Semen quality in hypogonadal acromegalic patients

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  2. Change in baseline characteristics over 20 years of adults with growth hormone (GH) deficiency on GH replacement therapy

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  3. Surgical Management, Preoperative Tumor Localization, and Histopathology of 80 Patients Operated on for Insulinoma

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Vis graf over relationer

INTRODUCTION: Patients with adrenal insufficiency have impaired health-related quality of life (QoL). The dual-release hydrocortisone preparation, Plenadren, has been developed to mimic the physiological cortisol release more closely than conventional hydrocortisone treatment. Plenadren has been shown to improve QoL, in particular fatigue, in patients with primary adrenal insufficiency. However, the effect has not been investigated in patients with secondary adrenal insufficiency; furthermore, no study has taken the diurnal variation of fatigue into account. To assess diurnal variations, it is necessary to use repeated daily measurements, such as ecological momentary assessments (EMAs). This study aims to evaluate EMAs of fatigue as outcome in future large-scale randomised clinical trials.

METHODS AND ANALYSIS: The PlenadrEMA trial is an investigator-initiated open-label switch pilot trial of the effect of Plenadren versus conventional hydrocortisone on fatigue in patients with secondary adrenal insufficiency. The trial will include 30 participants. After 5 weeks on their usual hydrocortisone treatment, patients will be shifted to Plenadren for 16 weeks. Fatigue will be assessed using momentary versions of the Multidimensional Fatigue Inventory (MFI-20). Items will be administered to participants via a smartphone application four times daily during 20 days. Assessments will be performed before treatment shift and repeated after 12.5 weeks on Plenadren. The study will identify the best suited outcome for future randomised clinical trials, and in addition, estimate the variability and difference in fatigue between the two treatments to perform power calculations.

ETHICS AND DISSEMINATION: The trial will be conducted in accordance with the Declaration of Helsinki and has been approved by the Regional Scientific Ethical Committee in Copenhagen (ID: H-1-2014-073). All patients will receive written and verbal information about the trial and will give informed consent before enrolment. Findings will be published in peer-reviewed journals and presented at international conferences.

TRIAL REGISTRATION NUMBER: EudraCT201400203932.

OriginalsprogEngelsk
TidsskriftBMJ Paediatrics Open
Vol/bind8
Udgave nummer1
Sider (fra-til)e019487
ISSN2044-6055
DOI
StatusUdgivet - 23 jan. 2018

ID: 52667463