Evaluating the Influence of Diabetes Stigma on Medication Adherence

Diabetes Mellitus Clinical Trial

— ENDSTIGMA  

Official title:

Evaluating the Influence of Diabetes Stigma on Medication Adherence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02828995
• Other study ID #: 160986
• Status: Completed
• Phase: N/A
• First received: June 20, 2016
• Last updated: January 23, 2018
• Start date: July 8, 2016
• Est. completion date: December 2017

Study information

• Verified date: January 2018
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The "Evaluating the iNfluence of Diabetes STIGma on Medication Adherence: The ENDSTIGMA Study" was designed to develop a comprehensive diabetes stigma survey measure. The draft measure will be piloted with approximately 50 patients visiting the Vanderbilt University Medical Center (VUMC) Diabetes Clinic. This pilot data will be used to validate the new survey measure and to determine if any questions in the diabetes stigma measure are predictive of diabetes medication adherence.

Description:

Diabetes mellitus (DM) is a chronic condition affecting an estimated 422 million adults worldwide and 28.9 million adults in the US. DM can lead to increased risk of mortality and significant complications including amputation, blindness, cardiovascular disease, and kidney damage. The risk of developing these outcomes can be mediated by early diagnosis and treatment, such as by patient self-management by lifestyle changes and/or taking medication. However, outcome improvement depends on control of blood glucose levels, which in turn depend on adherence to treatment. Several psychosocial factors are known to affect treatment adherence for chronic conditions, one of which is stigma.

Stigma arises when social norms result in the marginalization of people with a certain identity or trait. Negative stereotypes of people in the stigmatized group result in their systematic exclusion and/or discrimination. Chronic disease diagnosis itself can lead to the development of disease-specific identity-based stigma, in that a person's identity is disrupted by a new label (e.g. "diabetic") applied to them, until they incorporate this new label into a positive sense of self. Minority stress theory describes the impact of identity-based marginalization on health outcomes. According to minority stress theory, discrimination and stigma may lead to heightened stress levels, which can translate over time into heightened mental and physical health disparities for the stigmatized group. Categories of stigma experienced by patients include enacted stigma, perceived stigma, self-stigma, and concealment. Enacted stigma refers to acts of discrimination against people in a stigmatized group. Perceived stigma refers both to the fear of experiencing enacted stigma, as well as to the shame resulting from belonging to or being associated with a stigmatized group. Self-stigma refers to the internalization of negative group stereotypes by members of the stigmatized group. Concealment, also called non-disclosure, refers to the hiding of a stigmatized identity or condition.

Stigma has been shown to negatively affect access to care as well as quality of life in people living with chronic diseases. Disease-specific stigma scales have been developed for various conditions, including mental illness, HIV/AIDS, epilepsy, and obesity. These scales have been used to facilitate interventions to minimize negative effects of stigma on health behaviors and outcomes. In comparison to other health conditions, diabetes stigma has only recently emerged as a research topic of interest.

DM has been reported to be a health condition that is relatively less stigmatized in comparison to other conditions. One publication suggested in its introduction that "diabetes does not appear to have associated stigma." As such, there have been publications comparing the degree of stigma experienced by DM patients with those with conditions such as schizophrenia, dementia, HIV, depression, and hypertension. However, numerous qualitative studies interviewing people with diabetes have revealed that DM patients do experience significant disease-related stigma.

In the literature, DM-related enacted stigma examples include workplace discrimination (decreased chance of being hired and increased chance of job loss); threatened or actual termination of romantic relationships; and judgmental behavior from healthcare professionals. Likewise, examples of perceived stigma include fear of being characterized as an illicit drug user when injecting insulin in public; and feelings of isolation when choosing to eat different foods, particularly in family and cultural situations. Self-stigma and concealment examples include avoidance of social events; timing self-management so it can be done in isolation; and altering blood glucose recordings, so as to appear "healthy."

Despite ample evidence of the existence of DM-specific stigma, limited attempts have been made to measure it. The Diabetes Distress Scale (DDS) was designed to measure "emotional burden, physician-related distress, regimen-related distress, and…interpersonal distress" associated with DM. However, the DDS does not comprehensively measure all the types of stigma minority stress theory has shown to contribute to chronic disease health disparities. The Barriers to Diabetes Adherence measure includes six questions about stigma, but the scope of these questions was limited and targeted towards an adolescent population with Type 1 DM. A limited number of previous publications have adapted disease-specific stigma scales from other conditions or developed their own questionnaires for said conditions for their diabetes stigma research needs. To date, only one publication has developed and validated a stigma scale specifically for DM patients, and this measure only addressed self-stigma. Therefore, to our knowledge, there is currently no scale that measures multiple facets of DM-specific stigma that may be contributing to sub-optimal patient diabetes self-management. Given the relationship between stigma, treatment adherence, and adverse health outcomes for chronic disease patients, development of a comprehensive DM stigma scale may lead to improvements in DM patient centered care, which will be addressed by the following Specific Aims:

Specific Aims

1. Develop a novel quantitative measure that comprehensively measures enacted stigma, perceived stigma, and self-stigma and concealment specific to adult DM patients

2. Pilot the measure with 30-50 DM patients

3. Validate the measure and determine if DM stigma is associated with obesity, diabetes type, insulin use, and/or is predictive of medication adherence

Recruitment information / eligibility

• Status: Completed
• Enrollment: 508
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Type I or II DM for at least 1 year

• Taking at least 1 medication to manage diabetes

Exclusion Criteria:

• Under 18 years of age

• Non-English speaking

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Other:
• Comprehensive Diabetes Stigma Survey
The surveys to be administered in the ENDSTIGMA study are as follows: The Adherence to Refills and Medications for Diabetes survey is a validated, diabetes-specific survey measure utilizing patient self-report to assess diabetes medication adherence. The Demographics survey will be used to assess participant baseline characteristics, including body mass index (BMI). The questions contained in this survey have been validated by Dr. Kerri Cavanaugh's research group. Comprehensive Diabetes Stigma Survey is a novel survey being developed and validated in the ENDSTIGMA study. The ENDSTIGMA study will also compare the results from this survey with the medication adherence results, to determine if there is an association between diabetes stigma and medication adherence.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (39)

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* Note: There are 39 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diabetes Stigma	The composite stigma score from the Comprehensive Diabetes Stigma Survey measure will be calculated from patient survey responses.	Baseline
Primary	Diabetes Medication Adherence	The composite diabetes medication adherence score will be calculated from patient responses to the Adherence to Refills and Medications Scale - Diabetes (ARMS-D) survey.	Baseline
Secondary	Diabetes Patient Height (in Inches)	Self-Report of Diabetes Patient Height	Baseline
Secondary	Diabetes Patient Weight (in Pounds)	Self-Report of Diabetes Patient Weight	Baseline