Adrenal InsufficiencyNCT03399383
Adherence in Chronic Adrenal Insufficiency
A study testing Patient education in people with Adrenal Insufficiency, run by Wuerzburg University Hospital at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adrenal Insufficiency
- What is being tested?
- Patient education
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age < 18 years
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Wuerzburg
Würzburg, 97080
Stefanie Hahner, Prof.Dr., 0049-931-201-39200, Hahner_S@ukw.de
Stephanie Burger-Stritt, Dr., 0049-931-201-39200, Burger_S1@ukw.de
About this study
Official title: 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.
Read the 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).
- Conditions
- Adrenal Insufficiency
- Being tested
- Patient education
- Keywords
- Adrenal Insufficiency, Adrenal crisis, Adherence, Standardized patient education
- Medical subject headings
- Adrenal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient educationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient education (longitudinal analysis) | Other | Patients with adrenal insufficiency complete a questionnaire before and 6 months after participation in a standardised patient education. Receives: Other: Patient education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2018
- Study startSep 2016
- Primary completionSep 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Adrenal InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Graz, Medical practice for Endocrinology in Oldenburg, Germany, Charite University, Berlin, Germany, University Hospital, Frankfurt, Germany, Endocrinology in Charlottenburg, Berlin, Germany, University Hospital Munich, University Medical Center Rostock
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03399383
- Sponsor's protocol ID
- Compliance-TRIAL
- Status last verified
- Jan 2018
- First submitted
- 8 Jan 2018
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hahner S, Spinnler C, Fassnacht M, Burger-Stritt S, Lang K, Milovanovic D, Beuschlein F, Willenberg HS, Quinkler M, Allolio B. High incidence of adrenal crisis in educated patients with chronic adrenal insufficiency: a prospective study. J Clin Endocrinol Metab. 2015 Feb;100(2):407-16. doi: 10.1210/jc.2014-3191. Epub 2014 Nov 24.
PubMed 25419882Hahner S, Loeffler M, Fassnacht M, Weismann D, Koschker AC, Quinkler M, Decker O, Arlt W, Allolio B. Impaired subjective health status in 256 patients with adrenal insufficiency on standard therapy based on cross-sectional analysis. J Clin Endocrinol Metab. 2007 Oct;92(10):3912-22. doi: 10.1210/jc.2007-0685. Epub 2007 Aug 7.
PubMed 17684047Lovas K, Loge JH, Husebye ES. Subjective health status in Norwegian patients with Addison's disease. Clin Endocrinol (Oxf). 2002 May;56(5):581-8. doi: 10.1046/j.1365-2265.2002.01466.x.
PubMed 12030907Chapman SC, Llahana S, Carroll P, Horne R. Glucocorticoid therapy for adrenal insufficiency: nonadherence, concerns and dissatisfaction with information. Clin Endocrinol (Oxf). 2016 May;84(5):664-71. doi: 10.1111/cen.12991. Epub 2016 Feb 15.
PubMed 26641418Tiemensma J, Andela CD, Pereira AM, Romijn JA, Biermasz NR, Kaptein AA. Patients with adrenal insufficiency hate their medication: concerns and stronger beliefs about the necessity of hydrocortisone intake are associated with more negative illness perceptions. J Clin Endocrinol Metab. 2014 Oct;99(10):3668-76. doi: 10.1210/jc.2014-1527. Epub 2014 Sep 16.
PubMed 25226291Horne R, Weinman J. Patients' beliefs about prescribed medicines and their role in adherence to treatment in chronic physical illness. J Psychosom Res. 1999 Dec;47(6):555-67. doi: 10.1016/s0022-3999(99)00057-4.
PubMed 10661603
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence and Perception With Hormone Replacement Therapy in Chronic Adrenal Insufficiency - Influence of a Standardized Patient Education
- ClinicalTrials.gov ID
- NCT03399383
- Acronym / sponsor ID
- Compliance-TRIAL
- Conditions
- Adrenal Insufficiency
- Keywords
- Adrenal Insufficiency, Adrenal crisis, Adherence, Standardized patient education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Collaborators
- Medical University of Graz, Medical practice for Endocrinology in Oldenburg, Germany, Charite University, Berlin, Germany, University Hospital, Frankfurt, Germany, Endocrinology in Charlottenburg, Berlin, Germany, University Hospital Munich, University Medical Center Rostock
- Study start
- Sep 2016 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 16 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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).
| Arm | Type | Receives |
|---|---|---|
| Patient education (longitudinal analysis) | Other | Other: Patient educationPatients with adrenal insufficiency complete a questionnaire before and 6 months after participation in a standardised patient education. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Age < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient educationParticipation 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. | Other | Patient education (longitudinal analysis) |
Primary outcome
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Background: PubMed 25419882Hahner S, Spinnler C, Fassnacht M, Burger-Stritt S, Lang K, Milovanovic D, Beuschlein F, Willenberg HS, Quinkler M, Allolio B. High incidence of adrenal crisis in educated patients with chronic adrenal insufficiency: a prospective study. J Clin Endocrinol Metab. 2015 Feb;100(2):407-16. doi: 10.1210/jc.2014-3191. Epub 2014 Nov 24.
- Background: PubMed 17684047Hahner S, Loeffler M, Fassnacht M, Weismann D, Koschker AC, Quinkler M, Decker O, Arlt W, Allolio B. Impaired subjective health status in 256 patients with adrenal insufficiency on standard therapy based on cross-sectional analysis. J Clin Endocrinol Metab. 2007 Oct;92(10):3912-22. doi: 10.1210/jc.2007-0685. Epub 2007 Aug 7.
- Background: PubMed 12030907Lovas K, Loge JH, Husebye ES. Subjective health status in Norwegian patients with Addison's disease. Clin Endocrinol (Oxf). 2002 May;56(5):581-8. doi: 10.1046/j.1365-2265.2002.01466.x.
- Background: PubMed 26641418Chapman SC, Llahana S, Carroll P, Horne R. Glucocorticoid therapy for adrenal insufficiency: nonadherence, concerns and dissatisfaction with information. Clin Endocrinol (Oxf). 2016 May;84(5):664-71. doi: 10.1111/cen.12991. Epub 2016 Feb 15.
- Background: PubMed 25226291Tiemensma J, Andela CD, Pereira AM, Romijn JA, Biermasz NR, Kaptein AA. Patients with adrenal insufficiency hate their medication: concerns and stronger beliefs about the necessity of hydrocortisone intake are associated with more negative illness perceptions. J Clin Endocrinol Metab. 2014 Oct;99(10):3668-76. doi: 10.1210/jc.2014-1527. Epub 2014 Sep 16.
- Background: PubMed 10661603Horne R, Weinman J. Patients' beliefs about prescribed medicines and their role in adherence to treatment in chronic physical illness. J Psychosom Res. 1999 Dec;47(6):555-67. doi: 10.1016/s0022-3999(99)00057-4.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient education in people with Adrenal Insufficiency, run by Wuerzburg University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefanie Hahner, Prof. Dr. (0049-931-201-39200, Hahner_S@ukw.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beliefs about Medicines Questionnaire (BMQ) (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03399383, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.