Adherence in Chronic Adrenal Insufficiency

NCT03399383 | Unknown

• 1 other identifier: Compliance-TRIAL
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adrenal Insufficiency

Keywords

Adrenal Insufficiency; Adrenal crisis; Adherence; Standardized patient education

Outcome Measures

Primary Outcomes (3)

• 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

• 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

Study Arms (1)

Patient education (longitudinal analysis)

OTHER

Patients with adrenal insufficiency complete a questionnaire before and 6 months after participation in a standardised patient education.

Other: Patient education

Interventions

Patient education OTHER

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.

Patient education (longitudinal analysis)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age \< 18 years

Sponsors & Collaborators

• Wuerzburg University Hospital: lead
• Medical University of Graz, Austria: collaborator
• Medical practice for Endocrinology in Oldenburg, Germany: collaborator
• Charite University, Berlin, Germany: collaborator
• University Hospital, Frankfurt, Germany: collaborator
• Endocrinology in Charlottenburg, Berlin, Germany: collaborator
• University Hospital Munich, Germany: collaborator
• University Hospital of Rostock, Germany: collaborator

Study Sites (1)

University Hospital Wuerzburg

Würzburg, 97080, Germany

RECRUITING

Related Publications (6)

• 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.

  PMID: 25419882 BACKGROUND

• Hahner 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.

  PMID: 17684047 BACKGROUND

• Lovas 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.

  PMID: 12030907 BACKGROUND

• Chapman 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.

  PMID: 26641418 BACKGROUND

• Tiemensma 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.

  PMID: 25226291 BACKGROUND

• Horne 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.

  PMID: 10661603 BACKGROUND

MeSH Terms

Conditions

Adrenal Insufficiency

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Adrenal Gland Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Stefanie Hahner, Prof. Dr.

CONTACT

0049-931-201-39200; Hahner_S@ukw.de

Stephanie Burger-Stritt, Dr.

CONTACT

0049-931-201-39200; Burger_S1@ukw.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: January 16, 2018
• Study Start: September 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 23, 2018

Record last verified: 2018-01

Locations

DE (1)