Adherence in Chronic Adrenal Insufficiency

January 18, 2018 updated by: Wuerzburg University Hospital

Adherence and Perception With Hormone Replacement Therapy in Chronic Adrenal Insufficiency - Influence of a Standardized Patient Education

Adherence, concerns and satisfaction with information in German patients with adrenal insufficiency as well as the influence of a standardized education program will be assessed by a compared cross-sectional and longitudinal study.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients with adrenal insufficiency (AI) require a lifelong replacement therapy with glucocorticoids (GC). To avoid over- and under- replacement, an individual daily dose scheme and adequate dose adjustment during stressful events is essential. Recent patient surveys revealed nonadherence to treatment, concerns about GC and dissatisfaction with the provided information.

The aim of this trial is to evaluate the adherence, concerns and satisfaction with information in German patients with primary and secondary AI (PAI/SAI) and the influence of a standardized education program.

Patients with AI on GC therapy will be assessed by questionnaire, including the Medication Adherence Report Scale* (MARS), Beliefs about Medicines Questionnaire* (BMQ, adapted for AI) and Satisfaction with Information about Medicines Scale* (SIMS).*©Professor Rob Horne.

The study includes one cross-sectional-analysis and one longitudinal study (patient survey before and after participation at the standardized education program in Germany).

Study Type

Interventional

Enrollment (Anticipated)

150

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
        • Recruiting
        • University Hospital Wuerzburg
        • Contact:
          • Stephanie Burger-Stritt, Dr.
          • Phone Number: 0049-931-201-39200
          • Email: Burger_S1@ukw.de
        • Contact:
          • Stefanie Hahner, Prof.Dr.
          • Phone Number: 0049-931-201-39200
          • Email: Hahner_S@ukw.de

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 chronic adrenal insufficiency under established stable replacement therapy

Exclusion Criteria:

  • Age < 18 years

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: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Patient education (longitudinal analysis)
Patients with adrenal insufficiency complete a questionnaire before and 6 months after participation in a standardised patient education.
Other: Patient education
Participation in the standardized education program (90min patient education). During sessions of 90-120 minutes duration, patients 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beliefs about Medicines Questionnaire (BMQ)
Time Frame: 6 months
Evaluation of "Beliefs about Medicines" by BMQ-questionnaire (modified BMQ AI Specific© by Prof Rob Horne). The modified BMQ AI Specific© comprises: a 5-item Glucocorticoid-Necessity subscale assessing the participant's views about their personal need for the glucocorticoid medication and an 11-item Glucocorticoid-Concerns subscale assessing participants' concerns about the potential adverse consequences of taking glucocorticoids. For each BMQ statement, participants indicated their agreement on a 5-point Likert scale (range 1 = strongly disagree to 5 = strongly agree). GC-Necessity and GC-Concerns scores are computed by summing all subscale responses, then dividing by the number of items (range 1-5). Scores near five indicate high Necessity. Scores near one indicate high Concern.
6 months
Satisfaction with Information about Medicines Scale (SIMS)
Time Frame: 6 months
Evaluation of "Satisfaction with Information about Medicines" by SIMS-questionnaire (Prof Rob Horne). Participants complete the SIMS© to indicate their satisfaction with the information they had received about their glucocorticoids. The SIMS has two subscales. The first assesses satisfaction with the information received about the Action and Usage of glucocorticoids (SIMS AU 9-items). The second assesses satisfaction with information about dealing with Potential Problems associated with glucocorticoids (SIMS PP 8-items). For each subscale item, participants state whether they were satisfied with the amount of information they had received (about right, none needed) or dissatisfied (too much, too little, none received). Subscale scores are calculated by counting the total number of 'satisfied' responses.
6 months
Medication Adherence Report Scale (MARS)
Time Frame: 6 months
Evaluation of "Adherence" by MARS-questionnaire. Participants rate their adherence to glucocorticoids on an 8-item Medication Adherence Report Scale (MARS)© (Prof Rob Horne), modified for AI. Participants rate the frequency with which they perform each type of nonadherent behaviour on a 5-point scale (1=very to 5=never). Scores are summed to give a total score (range 8-40); higher scores indicate higher reported adherence.
6 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
Medical University of Graz, Austria
Medical practice for Endocrinology in Oldenburg, Germany
University Hospital, Frankfurt, Germany
Endocrinology in Charlottenburg, Berlin, Germany
University Hospital Munich, Germany
University Hospital of Rostock, Germany

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

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 (ACTUAL)

September 1, 2016

Primary Completion (ANTICIPATED)

September 1, 2018

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

January 8, 2018

First Submitted That Met QC Criteria

January 12, 2018

First Posted (ACTUAL)

January 16, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 23, 2018

Last Update Submitted That Met QC Criteria

January 18, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Compliance-TRIAL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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