Evaluating the Influence of Diabetes Stigma on Medication Adherence (ENDSTIGMA)

January 23, 2018 updated by: Kerri Cavanaugh, Vanderbilt University Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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

Study Type

Observational

Enrollment (Actual)

508

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232-2372
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants will be adult patients with an established diagnosis of diabetes and who are taking at least 1 medication to manage their diabetes.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Comprehensive Diabetes Stigma Survey
Participants in the END STIGMA study will be adult patients who have been receiving diabetes-related medical care for a minimum of 12 months in the Vanderbilt University Medical Center Diabetes Clinic and who take at least 1 medication to manage their diabetes.
Other: Comprehensive Diabetes Stigma Survey

The surveys to be administered in the ENDSTIGMA study are as follows:

  1. 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.
  2. 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.
  3. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diabetes Stigma
Time Frame: Baseline
The composite stigma score from the Comprehensive Diabetes Stigma Survey measure will be calculated from patient survey responses.
Baseline
Diabetes Medication Adherence
Time Frame: Baseline
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diabetes Patient Height (in Inches)
Time Frame: Baseline
Self-Report of Diabetes Patient Height
Baseline
Diabetes Patient Weight (in Pounds)
Time Frame: Baseline
Self-Report of Diabetes Patient Weight
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Investigators

  • Principal Investigator: Kerri Cavanaugh, MD/MHS, Vanderbilt University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2016

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

June 20, 2016

First Submitted That Met QC Criteria

July 11, 2016

First Posted (Estimate)

July 12, 2016

Study Record Updates

Last Update Posted (Actual)

January 25, 2018

Last Update Submitted That Met QC Criteria

January 23, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 160986

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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