National Education Programme for Patients With Chronic Adrenal Insufficiency

Not Applicable

Completed

• Conditions: Adrenal Insufficiency
• Interventions: Other: Education

• Registration Number: NCT02694926
• Lead Sponsor: Wuerzburg University Hospital

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.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2016-02-08
• Study First Submitted QC: 2016-02-24
• Study First Posted: 2016-03-01
• Primary Completion: 2017-11
• Status Verified: 2017-12
• Study Completion: 2017-12
• Last Update Submitted: 2018-01-18
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 528

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
adrenal insufficiency	Education	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Patient satisfaction /safety evaluated by questionnaire.	12-24 months	Evaluation via questionnaire including subjective multiple choice questions e.g. on the feeling of safety.

Trial Locations

Locations (1)

University Hospital Wuerzburg; 🇩🇪 Wuerzburg, Germany