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Clinical Trials/NCT02836015
NCT02836015
Completed
N/A

Shared Medical Visits for Spanish-speaking Patients With Type 2 Diabetes

University of Nebraska1 site in 1 country9 target enrollmentMay 13, 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Diabetes Mellitus Type 2
Sponsor
University of Nebraska
Enrollment
9
Locations
1
Primary Endpoint
Hemoglobin A1c
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The investigators seek to apply a shared medical visit model and interdisciplinary approach to Spanish-speaking patients. The investigators will evaluate the patient's hemoglobin A1c as a marker of glycemic control and evaluate their mood with PHQ screening tools. The investigators seek to improve diabetes care for this group of underserved patients. Potential participants will be selected from the UNMC diabetes registry. Eligibility criteria includes adult patients over the age of eighteen years old with Type 2 diabetes, HgbA1c greater than 8%, whose preferred language is Spanish. Exclusion criteria include pregnancy, residency at a nursing home or other facility, substance abuse, and physician recommendation that study is not appropriate for the patient.

Detailed Description

Type 2 diabetes is an expanding epidemic, which is particularly pervasive in the Hispanic community. In 2014, the CDC reported that 21.9 million adults have been diagnosed with diabetes, a number which has nearly quadrupled since 1980. Diabetes is a particularly challenging chronic disease due to the need for self-management. This research study plans to explore how shared medical visits with Spanish-speaking patients with diabetes can improve their control of diabetes, develop self-management behaviors, and enhance overall perspective of having a chronic disease. The investigators will model this project after an ongoing with English speakers and they have demonstrated improvements in hemoglobin A1c levels and quality of life, and will now apply this model to Spanish-speaking patients. Eligibility and exclusion criteria are detailed in the brief summary. Eligible participants will be recruited for the study through use of phone call in Spanish, letter writing in Spanish, word of mouth, and direct referral from their providers throughout UNMC. Once the list of potential subjects is compiled, those patients will be contacted and the details of the study will be explained in Spanish. All the participating staff in the study speak Spanish. The participants, at any time, can withdraw from the study. Participants will receive education in diabetes health and lifestyle education. This will be a quantitative study using pre- and post-intervention measures to evaluate the outcomes of HgbA1c levels, scores on the validated 2-item and 9-item Patient Health Questionnaires (PHQ-2 and PHQ-9), and questionnaire which measures improvements in self-management behaviors. Researchers will to follow-up with the participants in the week following the visit to discuss lab results. At the end of the study, researcher will send a detailed letter to the patient's primary care provider regarding progress and management in shared medical visits.

Registry
clinicaltrials.gov
Start Date
May 13, 2016
End Date
June 30, 2017
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adult patients over the age of eighteen years old with Type 2 diabetes
  • HgbA1c greater than 8%
  • Preferred language is Spanish

Exclusion Criteria

  • Pregnancy
  • Residency at a nursing home or other facility
  • Substance abuse
  • Physician recommendation that study is not appropriate for the patient

Outcomes

Primary Outcomes

Hemoglobin A1c

Time Frame: Every three months, up to 1 year

Every 3 months we will measure hemoglobin A1c to assess for improvement in glycemic control.

Secondary Outcomes

  • Improvement in self care behaviors(Every three months, up to 1 year)
  • Blood pressure(Every 3 months, up to 1 year)
  • Screening for complications of diabetes(Once annually, up to 1 year)
  • Barriers to care for Spanish-speaking patients with diabetes(Every 3 months, up to 1 year)
  • BMI(Every 3 months, up to 1 year)
  • PHQ-2 and PHQ-0 Depression screening tool(Every three months, up to 1 year)

Study Sites (1)

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