NCT02694926

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
528

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 23, 2018

Status Verified

December 1, 2017

Enrollment Period

2.9 years

First QC Date

February 8, 2016

Last Update Submit

January 18, 2018

Conditions

Adrenal Insufficiency

Keywords

adrenal crisiseducation programme

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Patient satisfaction /safety evaluated by questionnaire.

    12-24 months

Study Arms (1)

adrenal insufficiency

OTHER
Other: Education

Interventions

EducationOTHER

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

adrenal insufficiency

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Wuerzburg

Würzburg, 97080, Germany

Location

Related Publications (7)

  • 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.

    PMID: 25419882BACKGROUND

  • 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.

    PMID: 25200922BACKGROUND

  • 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.

    PMID: 19955259BACKGROUND

  • 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.

    PMID: 25288693BACKGROUND

  • 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.

    PMID: 26208266BACKGROUND

  • 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.

    PMID: 22513882BACKGROUND

  • 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.

    PMID: 23636446BACKGROUND

Related Links

MeSH Terms

Conditions

Adrenal Insufficiency

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Adrenal Gland DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Stefanie Hahner, MD, Prof.

    University Hospital Wuerzburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2016

First Posted

March 1, 2016

Study Start

December 1, 2014

Primary Completion

November 1, 2017

Study Completion

December 1, 2017

Last Updated

January 23, 2018

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will share

publication of collected data in medical journals and specialist congresses

Locations

DE(1)