Adherence in Chronic Adrenal Insufficiency

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Adrenal Insufficiency

Intervention / Treatment
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* Other: Patient education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Within the longitudinal part of the trial, patients with chronic adrenal insufficiency will be assessed by questionnaire before and after participation in the standardized education program (=intervention).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patient education (longitudinal analysis)<br>Patients with adrenal insufficiency complete a questionnaire before and 6 months after participation in a standardised patient education. | Other: Patient education<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 6 months | 
| 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adrenal Insufficiency, Adrenal crisis, Adherence, Standardized patient education