NCT02694926

National Education Programme for Patients With Chronic Adrenal Insufficiency

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 528 (actual)
• Sponsor: Wuerzburg University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Adrenal Insufficiency

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-12-01
• Primary completion: 2017-11-01
• Completion: 2017-12-01
• First posted: 2016-03-01
• Last updated: 2018-01-23

Locations

1 site across 1 country: Germany