Evaluating the Influence of Diabetes Stigma on Medication Adherence

NCT02828995 | Completed

• 1 other identifier: 160986
• Study Type: observational
• Target: 508
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus

Keywords

Diabetes Mellitus; Stigma; Social Determinants of Health

Outcome Measures

Primary Outcomes (2)

• Diabetes Stigma

  The composite stigma score from the Comprehensive Diabetes Stigma Survey measure will be calculated from patient survey responses.

  Baseline

• 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 Outcomes (2)

• Diabetes Patient Height (in Inches)

  Baseline

• Diabetes Patient Weight (in Pounds)

  Baseline

Study Arms (1)

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

Interventions

Comprehensive Diabetes Stigma Survey OTHER

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.

Comprehensive Diabetes Stigma Survey

Eligibility Criteria

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

You may qualify if:

• years of age or older
• Type I or II DM for at least 1 year
• Taking at least 1 medication to manage diabetes

You may not qualify if:

• Under 18 years of age
• Non-English speaking

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-2372, United States

Location

Related Publications (39)

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MeSH Terms

Conditions

Diabetes Mellitus; Social Stigma

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Social Behavior; Behavior

Study Officials

• Kerri Cavanaugh, MD/MHS

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: June 20, 2016
• First Posted: July 12, 2016
• Study Start: July 8, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 25, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)