National Education Programme for Patients With Chronic Adrenal Insufficiency

January 18, 2018 updated by: Wuerzburg University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

528

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Wuerzburg, Germany, 97080
        • University Hospital Wuerzburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: adrenal insufficiency
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12-24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12-24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuerzburg University Hospital

Collaborators

Charite University, Berlin, Germany
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
MVZ Endokrinologikum Saarbrücken, Europaallee 15, 66113 Saarbrücken

Investigators

  • Principal Investigator: Stefanie Hahner, MD, Prof., University Hospital Wuerzburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

February 8, 2016

First Submitted That Met QC Criteria

February 24, 2016

First Posted (Estimate)

March 1, 2016

Study Record Updates

Last Update Posted (Actual)

January 23, 2018

Last Update Submitted That Met QC Criteria

January 18, 2018

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nationales Schulungsprogramm

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

publication of collected data in medical journals and specialist congresses

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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