An interventional study of Shared Medical Visit in Diabetes Mellitus Type 2, sponsored by University of Nebraska. Completed at 1 site in United States. Open to participants aged 19 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-28.
Sponsored by University of Nebraska · Not applicable, Interventional, and Treatment
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.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 9 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →University of Nebraska is the lead sponsor of 473 studies on the registry; 66 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 46 (61%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All patients will be enrolled in the experimental group and will be involved in shared medical visits.
Behavioral: Shared Medical Visit
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.
Also known as: SMV
Hemoglobin A1c
Every 3 months we will measure hemoglobin A1c to assess for improvement in glycemic control.
Time frame: Every three months, up to 1 year
Improvement in self care behaviors
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
Time frame: Every three months, up to 1 year
Barriers to care for Spanish-speaking patients with diabetes
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.
Time frame: Every 3 months, up to 1 year
Screening for complications of diabetes
Urine microalbumin/creatinine ratio, low density lipoprotein, yearly dilated eye exam, yearly flu shot, and yearly diabetic foot exam.
Time frame: Once annually, up to 1 year
PHQ-2 and PHQ-0 Depression screening tool
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.
Time frame: Every three months, up to 1 year
Blood pressure
Assessment of blood pressure at each visit, with goal for improvement in blood pressure control.
Time frame: Every 3 months, up to 1 year
BMI
Participants will have height and weight measured at each visit which allows for calculation of BMI
Time frame: Every 3 months, up to 1 year
Plan to share: No
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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University of Nebraska