National Education Programme for Patients With Chronic Adrenal Insufficiency

Adrenal Insufficiency Clinical Trial

Official title:

National (German-wide) Education Programme for Patients With Chronic Adrenal Insufficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02694926
• Other study ID #: Nationales Schulungsprogramm
• Status: Completed
• Phase: N/A
• First received: February 8, 2016
• Last updated: January 18, 2018
• Start date: December 2014
• Est. completion date: December 2017

Study information

• Verified date: December 2017
• Source: Wuerzburg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 528
• Est. completion date: December 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adrenal Insufficiency

Intervention

Other:
• Education
During a session of 90 minutes duration, patients are educated in basic knowledge on adrenal insufficiency including the correct behaviour in emergency settings.

Locations

Country	Name	City	State
Germany	University Hospital Wuerzburg	Wuerzburg

Sponsors (9)

Lead Sponsor

Collaborator

Wuerzburg University Hospital

Charite University, Berlin, Germany, Dr. Gesine Meyer, Universitätsklinikum Frankfurt, 60590 Frankfurt am Main, Dr. Michael Droste, Elisenstraße 12, 26122 Oldenburg, MVZ Endokrinologikum Saarbrücken, Europaallee 15, 66113 Saarbrücken, PD Dr. Nicole Reisch, LMU München, D-80336 München, Prof. Dr. Holger Willenberg, Zentrum für Innere Medizin, D-18057 Rostock, Prof. Dr. Marcus Quinkler, Praxis für Endokrinologie,10627 Berlin, Prof. Johannes Klein, Zentrum Endokrine Medizin, 23564 Lübeck

Country where clinical trial is conducted

Germany, 

References & Publications (7)

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. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficiency of education evaluated by questionnaire.	To evaluate the efficiency of the education programme patients complete three questionnaires. Questionnaires asses the general knowledge on adrenal insufficiency and the correct behavior in emergency settings via multiple choice questions. Overall scores before and after training will be compared	12-24 months
Secondary	Patient satisfaction /safety evaluated by questionnaire.	Evaluation via questionnaire including subjective multiple choice questions e.g. on the feeling of safety.	12-24 months

External Links

•   German society of endocrinology