- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02836015
Shared Medical Visits for Spanish-speaking Patients With Type 2 Diabetes (SMV)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Nebraska
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Omaha, Nebraska, United States, 68131
- Nebraska Medicine, Midtown Health Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Shared Medical Visit Groups
All patients will be enrolled in the experimental group and will be involved in shared medical visits.
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The Shared Medical Visits are a replacement for standard diabetic visits with PCP, and will occur completely in Spanish, the patients' preferred primary language.
An interdisciplinary group including behavioral health, social work, pharmacy, MD, and diabetic educator will be involved in the visit.
The focal point of the meeting is a 30 minute session in which all members are seated around a large table in the Midtown SMV area and each patient's blood sugars, labs, and medications are discussed in front of the entire group.
Pertinent labs and vaccines are drawn/administered.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hemoglobin A1c
Time Frame: Every three months, up to 1 year
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Every 3 months we will measure hemoglobin A1c to assess for improvement in glycemic control.
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Every three months, up to 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in self care behaviors
Time Frame: Every three months, up to 1 year
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See improvement in self care behaviors as defined by American Association of Diabetes Educators1: healthy eating, being active, monitoring, taking medication, problem solving, reducing risks, and healthy coping
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Every three months, up to 1 year
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Barriers to care for Spanish-speaking patients with diabetes
Time Frame: Every 3 months, up to 1 year
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Identify barriers to care for Spanish-speaking patients with diabetes, which are specific to this minority group, in order to improve care of this specific population.
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Every 3 months, up to 1 year
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Screening for complications of diabetes
Time Frame: Once annually, up to 1 year
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Urine microalbumin/creatinine ratio, low density lipoprotein, yearly dilated eye exam, yearly flu shot, and yearly diabetic foot exam.
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Once annually, up to 1 year
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PHQ-2 and PHQ-0 Depression screening tool
Time Frame: Every three months, up to 1 year
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Evaluate change in the overall mood of patients with diabetes, as measured by reduced scores on the validated depression screening assessments.
Each patient will always be administered the PHQ-2, a 2 question survey, and if they screen positive for depression on that they will be administered a PHQ-9, 9 question depression screening tool.
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Every three months, up to 1 year
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Blood pressure
Time Frame: Every 3 months, up to 1 year
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Assessment of blood pressure at each visit, with goal for improvement in blood pressure control.
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Every 3 months, up to 1 year
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BMI
Time Frame: Every 3 months, up to 1 year
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Participants will have height and weight measured at each visit which allows for calculation of BMI
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Every 3 months, up to 1 year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Leslie A Eiland, MD, University of Nebraska
Publications and helpful links
General Publications
- Trento M, Passera P, Tomalino M, Bajardi M, Pomero F, Allione A, Vaccari P, Molinatti GM, Porta M. Group visits improve metabolic control in type 2 diabetes: a 2-year follow-up. Diabetes Care. 2001 Jun;24(6):995-1000. doi: 10.2337/diacare.24.6.995.
- Pyatak EA, Florindez D, Peters AL, Weigensberg MJ. "We are all gonna get diabetic these days": the impact of a living legacy of type 2 diabetes on Hispanic young adults' diabetes care. Diabetes Educ. 2014 Sep-Oct;40(5):648-58. doi: 10.1177/0145721714535994. Epub 2014 May 27.
- Edelman D, Gierisch JM, McDuffie JR, Oddone E, Williams JW Jr. Shared medical appointments for patients with diabetes mellitus: a systematic review. J Gen Intern Med. 2015 Jan;30(1):99-106. doi: 10.1007/s11606-014-2978-7. Epub 2014 Aug 9.
- McCloskey J, Flenniken D. Overcoming cultural barriers to diabetes control: a qualitative study of southwestern New Mexico Hispanics. J Cult Divers. 2010 Fall;17(3):110-5.
- Ramal E, Petersen AB, Ingram KM, Champlin AM. Factors that influence diabetes self-management in Hispanics living in low socioeconomic neighborhoods in San Bernardino, California. J Immigr Minor Health. 2012 Dec;14(6):1090-6. doi: 10.1007/s10903-012-9601-y.
- Ell K, Katon W, Xie B, Lee PJ, Kapetanovic S, Guterman J, Chou CP. Collaborative care management of major depression among low-income, predominantly Hispanic subjects with diabetes: a randomized controlled trial. Diabetes Care. 2010 Apr;33(4):706-13. doi: 10.2337/dc09-1711. Epub 2010 Jan 22.
- Bohn J, Burrowes N, Pinkston L, Riddett M, Chalmers S. Diabetes care for Hispanic patients: honoring culture while promoting glycemic control. Adv Nurse Pract. 2010 Jan;18(1):46-8. No abstract available.
- Jaber R, Braksmajer A, Trilling JS. Group visits: a qualitative review of current research. J Am Board Fam Med. 2006 May-Jun;19(3):276-90. doi: 10.3122/jabfm.19.3.276.
- Gutierrez N, Gimple NE, Dallo FJ, Foster BM, Ohagi EJ. Shared medical appointments in a residency clinic: an exploratory study among Hispanics with diabetes. Am J Manag Care. 2011 Jun 1;17(6 Spec No.):e212-4.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0146-16-EP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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