Clinical Trial: National Education Programme for Patients With Chronic Adrenal Insufficiency

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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 voluntari
Sponsor: Wuerzburg University Hospital

Current Primary Outcome: Efficiency of education evaluated by questionnaire. [ Time Frame: 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


Original Primary Outcome: Same as current

Current Secondary Outcome: Patient satisfaction /safety evaluated by questionnaire. [ Time Frame: 12-24 months ]

Evaluation via questionnaire including subjective multiple choice questions e.g. on the feeling of safety.


Original Secondary Outcome: Same as current

Information By: Wuerzburg University Hospital

Dates:
Date Received: February 8, 2016
Date Started: December 2014
Date Completion: December 2016
Last Updated: March 2, 2016
Last Verified: March 2016