An interventional study of Patient education in Adrenal Insufficiency, sponsored by Wuerzburg University Hospital. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-23.
Sponsored by Wuerzburg University Hospital · Not applicable, Interventional, and Other
Among 17 studies in Adrenal Insufficiency with a site in Germany — 1 open to participants now, 1 under way, none of them phase 3. Adrenal Insufficiency · Germany.
Among the 17 studies in Adrenal Insufficiency with a site in Germany, this one is the 3rd largest by planned enrollment of the 10 interventional ones that give a count, is one of 2 that started in 2016, is one of 4 with no phase, and was the 12th registered.
136 studies on the registry are indexed under Adrenal Insufficiency; 27 are open to participants now.
Browse Adrenal Insufficiency studies →1 of the 17 studies in Adrenal Insufficiency with a site in Germany is open now. Recruiting first, the newest first:
Alexion Pharmaceuticals, Inc. · Sites in Germany, United States, Italy and 1 more country
Ages 18+
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 20 Adrenal Insufficiency studies recruiting now, 7 (35%) set no upper age limit and 7 (35%) stop at 75 or younger; 5 take children under 18; 5 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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17 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 2 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 150 is above the median of 44 across 71 interventional studies indexed under Adrenal Insufficiency.
Median enrollment 47 across the 10 interventional studies, 70 across the 6 observational. Of the 14 that completed or were terminated, 2 (14%) have results posted.
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5 of 17 have an industry lead sponsor. The 9 most frequent:
Wuerzburg University Hospital is the lead sponsor of 98 studies on the registry; 19 are open to participants now.
Wuerzburg University Hospital has 8 studies filed under Adrenal Insufficiency — fewer than ten, so there is no comparison to draw.
1 of the studies in Adrenal Insufficiency with a site in Germany that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07221838Alexion Pharmaceuticals, Inc.A Study to Investigate OCS Tapering in Adult Participants With Generalized Myasthenia Gravis Treated With Ravulizumab | 2027-08-27 |
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Among the 17 studies in Adrenal Insufficiency with a site in Germany, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Beliefs about Medicines Questionnaire (BMQ)
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.
Time frame: 6 months
Satisfaction with Information about Medicines Scale (SIMS)
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.
Time frame: 6 months
Medication Adherence Report Scale (MARS)
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.
Time frame: 6 months
Plan to share: Undecided
Started Sep 2016 (actual). Primary completion is estimated for Sep 2018, 24 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Wuerzburg University Hospital