Clinical trial NCT02694926: National Education Programme for Patients With Chronic Adrenal Insufficiency
Official title: National (German-wide) Education Programme for Patients With Chronic Adrenal Insufficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adrenal Insufficiency
Keywords: adrenal crisis
education programme
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
Collaborators: name: Dr. Michael Droste, Elisenstraße 12, 26122 Oldenburg
name: Prof. Dr. Marcus Quinkler, Praxis für Endokrinologie,10627 Berlin
name: Dr. Gesine Meyer, Universitätsklinikum Frankfurt, 60590 Frankfurt am Main
name: PD Dr. Nicole Reisch, LMU München, D-80336 München
name: Prof. Dr. Holger Willenberg, Zentrum für Innere Medizin, D-18057 Rostock
name: Prof. Johannes Klein, Zentrum Endokrine Medizin, 23564 Lübeck
name: Charite University, Berlin, Germany
name: MVZ Endokrinologikum Saarbrücken, Europaallee 15, 66113 Saarbrücken
First posted: 2016-03-01
Enrollment: 528
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Even under established replacement therapy, patients with adrenal insufficiency still suffer from impaired quality of life and experience adrenal crises. Patient education is regarded as important preventive measure. In this study a german-wide standardized education Programme will be evaluated.

Detailed description: Design aspects:

In a prospective trial the efficiency of a german-wide education programme in patients with chronic adrenal insufficiency will be evaluated by using a questionnaire before and after training.

Patients:

Patients will be recruited out of the patient population of the participating nine medical centers. To achieve a anticipated number of 450 patients, each center will include al least 50 patients with chronic adrenal insufficiency under established replacement therapy .

Trial flow:

During sessions of 90 minutes duration, patients and relatives are educated in basic knowledge on adrenal insufficiency including the correct behaviour in emergency settings. Participants are provided with emergency cards and sets and are trained in self-injection of glucocorticoids. To evaluate the standardized education programme, patients complete three questionnaires (before, shortly after and 6-9 months after the training) at nine endocrine centres. All centres had been certified by the German Endocrine Society for the education programme. Questionnaires assess general knowledge on adrenal insufficiency and document the influence on patients' feeling of security.

Statistical Analysis:

Documentation and analysis will be performed at the Department of Medicine I, Endocrine and Diabetes Unit, University of Würzburg, Germany. Data will be documented after pseudonymisation in a data base. Data analysis is mainly descriptive.

Stopping rules:

Participation of patients is fully voluntarily. Patients are able to stop participation in the study at any point in time. In addition, patients might claim the elimination of all data material at any point in time.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* patient's written informed consent
* Ability to comply with the protocol procedures
* patients with primary or secondary adrenal insufficiency under established stable replacement therapy

Primary outcomes:
measure: Efficiency of education evaluated by questionnaire.
timeFrame: 12-24 months
Secondary outcomes:
measure: Patient satisfaction /safety evaluated by questionnaire.
timeFrame: 12-24 months
Other outcomes:
Locations:
city: Wuerzburg
country: Germany
facility: University Hospital Wuerzburg
Study officials:
affiliation: University Hospital Wuerzburg
name: Stefanie Hahner, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hahner S, Spinnler C, Fassnacht M, Burger-Stritt S, Lang K, Milovanovic D, Beuschlein F, Willenberg HS, Quinkler M, Allolio B. High incidence of adrenal crisis in educated patients with chronic adrenal insufficiency: a prospective study. J Clin Endocrinol Metab. 2015 Feb;100(2):407-16. doi: 10.1210/jc.2014-3191. Epub 2014 Nov 24.
citation: Hahner S, Hemmelmann N, Quinkler M, Beuschlein F, Spinnler C, Allolio B. Timelines in the management of adrenal crisis - targets, limits and reality. Clin Endocrinol (Oxf). 2015 Apr;82(4):497-502. doi: 10.1111/cen.12609. Epub 2014 Nov 6.
citation: Hahner S, Loeffler M, Bleicken B, Drechsler C, Milovanovic D, Fassnacht M, Ventz M, Quinkler M, Allolio B. Epidemiology of adrenal crisis in chronic adrenal insufficiency: the need for new prevention strategies. Eur J Endocrinol. 2010 Mar;162(3):597-602. doi: 10.1530/EJE-09-0884. Epub 2009 Dec 2.
citation: Allolio B. Extensive expertise in endocrinology. Adrenal crisis. Eur J Endocrinol. 2015 Mar;172(3):R115-24. doi: 10.1530/EJE-14-0824. Epub 2014 Oct 6.
citation: Smans LC, Van der Valk ES, Hermus AR, Zelissen PM. Incidence of adrenal crisis in patients with adrenal insufficiency. Clin Endocrinol (Oxf). 2016 Jan;84(1):17-22. doi: 10.1111/cen.12865. Epub 2015 Aug 27.
citation: Reisch N, Willige M, Kohn D, Schwarz HP, Allolio B, Reincke M, Quinkler M, Hahner S, Beuschlein F. Frequency and causes of adrenal crises over lifetime in patients with 21-hydroxylase deficiency. Eur J Endocrinol. 2012 Jul;167(1):35-42. doi: 10.1530/EJE-12-0161. Epub 2012 Apr 18.
citation: Repping-Wuts HJ, Stikkelbroeck NM, Noordzij A, Kerstens M, Hermus AR. A glucocorticoid education group meeting: an effective strategy for improving self-management to prevent adrenal crisis. Eur J Endocrinol. 2013 May 17;169(1):17-22. doi: 10.1530/EJE-12-1094. Print 2013 Jul.