Adrenal Insufficiency Clinical Trial
Official title:
National (German-wide) Education Programme for Patients With Chronic Adrenal Insufficiency
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.
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.
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