Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2016-09-30
2018-12-31
Brief Summary
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Detailed Description
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The aim of this trial is to evaluate the adherence, concerns and satisfaction with information in German patients with primary and secondary AI (PAI/SAI) and the influence of a standardized education program.
Patients with AI on GC therapy will be assessed by questionnaire, including the Medication Adherence Report Scale\* (MARS), Beliefs about Medicines Questionnaire\* (BMQ, adapted for AI) and Satisfaction with Information about Medicines Scale\* (SIMS).\*©Professor Rob Horne.
The study includes one cross-sectional-analysis and one longitudinal study (patient survey before and after participation at the standardized education program in Germany).
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Patient education (longitudinal analysis)
Patients with adrenal insufficiency complete a questionnaire before and 6 months after participation in a standardised patient education.
Patient education
Participation in the standardized education program (90min patient education). During sessions of 90-120 minutes duration, patients 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.
Interventions
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Patient education
Participation in the standardized education program (90min patient education). During sessions of 90-120 minutes duration, patients 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.
Eligibility Criteria
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Inclusion Criteria
* Patient's written informed consent
* Ability to comply with the protocol procedures
* Patients with chronic adrenal insufficiency under established stable replacement therapy
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Medical University of Graz, Austria
UNKNOWN
Medical practice for Endocrinology in Oldenburg, Germany
UNKNOWN
Charite University, Berlin, Germany
OTHER
University Hospital, Frankfurt, Germany
UNKNOWN
Endocrinology in Charlottenburg, Berlin, Germany
UNKNOWN
University Hospital Munich, Germany
UNKNOWN
University Hospital of Rostock, Germany
UNKNOWN
Wuerzburg University Hospital
OTHER
Responsible Party
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Locations
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University Hospital Wuerzburg
Würzburg, , Germany
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Hahner S, Loeffler M, Fassnacht M, Weismann D, Koschker AC, Quinkler M, Decker O, Arlt W, Allolio B. Impaired subjective health status in 256 patients with adrenal insufficiency on standard therapy based on cross-sectional analysis. J Clin Endocrinol Metab. 2007 Oct;92(10):3912-22. doi: 10.1210/jc.2007-0685. Epub 2007 Aug 7.
Lovas K, Loge JH, Husebye ES. Subjective health status in Norwegian patients with Addison's disease. Clin Endocrinol (Oxf). 2002 May;56(5):581-8. doi: 10.1046/j.1365-2265.2002.01466.x.
Chapman SC, Llahana S, Carroll P, Horne R. Glucocorticoid therapy for adrenal insufficiency: nonadherence, concerns and dissatisfaction with information. Clin Endocrinol (Oxf). 2016 May;84(5):664-71. doi: 10.1111/cen.12991. Epub 2016 Feb 15.
Tiemensma J, Andela CD, Pereira AM, Romijn JA, Biermasz NR, Kaptein AA. Patients with adrenal insufficiency hate their medication: concerns and stronger beliefs about the necessity of hydrocortisone intake are associated with more negative illness perceptions. J Clin Endocrinol Metab. 2014 Oct;99(10):3668-76. doi: 10.1210/jc.2014-1527. Epub 2014 Sep 16.
Horne R, Weinman J. Patients' beliefs about prescribed medicines and their role in adherence to treatment in chronic physical illness. J Psychosom Res. 1999 Dec;47(6):555-67. doi: 10.1016/s0022-3999(99)00057-4.
Other Identifiers
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Compliance-TRIAL
Identifier Type: -
Identifier Source: org_study_id
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