Clinical trial NCT03399383: Adherence in Chronic Adrenal Insufficiency
Official title: Adherence and Perception With Hormone Replacement Therapy in Chronic Adrenal Insufficiency - Influence of a Standardized Patient Education
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adrenal Insufficiency
Keywords: Adrenal Insufficiency
Adrenal crisis
Adherence
Standardized patient education
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
Collaborators: name: Medical University of Graz, Austria
name: Medical practice for Endocrinology in Oldenburg, Germany
name: Charite University, Berlin, Germany
name: University Hospital, Frankfurt, Germany
name: Endocrinology in Charlottenburg, Berlin, Germany
name: University Hospital Munich, Germany
name: University Hospital of Rostock, Germany
First posted: 2018-01-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Within the longitudinal part of the trial, patients with chronic adrenal insufficiency will be assessed by questionnaire before and after participation in the standardized education program (=intervention).
Primary purpose: OTHER

Brief summary: Adherence, concerns and satisfaction with information in German patients with adrenal insufficiency as well as the influence of a standardized education program will be assessed by a compared cross-sectional and longitudinal study.

Detailed description: Patients with adrenal insufficiency (AI) require a lifelong replacement therapy with glucocorticoids (GC). To avoid over- and under- replacement, an individual daily dose scheme and adequate dose adjustment during stressful events is essential. Recent patient surveys revealed nonadherence to treatment, concerns about GC and dissatisfaction with the provided information.

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).

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Patient's written informed consent
* Ability to comply with the protocol procedures
* Patients with chronic adrenal insufficiency under established stable replacement therapy

Exclusion Criteria:

* Age \< 18 years

Primary outcomes:
measure: Beliefs about Medicines Questionnaire (BMQ)
timeFrame: 6 months
measure: Satisfaction with Information about Medicines Scale (SIMS)
timeFrame: 6 months
measure: Medication Adherence Report Scale (MARS)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wuerzburg
country: Germany
facility: University Hospital Wuerzburg
Study officials:
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, 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.