NCT03399383

Adherence in Chronic Adrenal Insufficiency

Adherence and Perception With Hormone Replacement Therapy in Chronic Adrenal Insufficiency - Influence of a Standardized Patient Education

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Wuerzburg University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Adrenal Insufficiency

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2016-09-01
• Primary completion: 2018-09-01
• Completion: 2018-12-01
• First posted: 2018-01-16
• Last updated: 2018-01-23

Locations

1 site across 1 country: Germany