Adrenal Insufficiency
Conditions
Keywords
adrenal crisis, education programme
Brief 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.
Interventions
OTHEREducation
During a session of 90 minutes duration, patients are educated in basic knowledge on adrenal insufficiency including the correct behaviour in emergency settings.
Sponsors
Dr. Michael Droste, Elisenstraße 12, 26122 Oldenburg
Prof. Dr. Marcus Quinkler, Praxis für Endokrinologie,10627 Berlin
Dr. Gesine Meyer, Universitätsklinikum Frankfurt, 60590 Frankfurt am Main
PD Dr. Nicole Reisch, LMU München, D-80336 München
Prof. Dr. Holger Willenberg, Zentrum für Innere Medizin, D-18057 Rostock
Prof. Johannes Klein, Zentrum Endokrine Medizin, 23564 Lübeck
Charite University, Berlin, Germany
MVZ Endokrinologikum Saarbrücken, Europaallee 15, 66113 Saarbrücken
Wuerzburg University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * patient's written informed consent * Ability to comply with the protocol procedures * patients with primary or secondary adrenal insufficiency under established stable replacement therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficiency of education evaluated by questionnaire. | 12-24 months | To evaluate the efficiency of the education programme patients complete three questionnaires. Questionnaires asses the general knowledge on adrenal insufficiency and the correct behavior in emergency settings via multiple choice questions. Overall scores before and after training will be compared |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction /safety evaluated by questionnaire. | 12-24 months | Evaluation via questionnaire including subjective multiple choice questions e.g. on the feeling of safety. |
Countries
Germany
Outcome results
None listed