Shared Medical Visits for Spanish-speaking Patients With Type 2 Diabetes (SMV)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02836015|
Recruitment Status : Completed
First Posted : July 18, 2016
Last Update Posted : October 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Type 2||Behavioral: Shared Medical Visit||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Shared Medical Visits for Spanish-speaking Patients With Type 2 Diabetes|
|Study Start Date :||May 2016|
|Actual Primary Completion Date :||June 30, 2017|
|Actual Study Completion Date :||June 30, 2017|
Experimental: Shared Medical Visit Groups
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.
Other Name: SMV
- 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.
- Improvement in self care behaviors [ Time Frame: Every three months, up to 1 year ]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
- Barriers to care for Spanish-speaking patients with diabetes [ Time Frame: Every 3 months, up to 1 year ]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.
- Screening for complications of diabetes [ Time Frame: Once annually, up to 1 year ]Urine microalbumin/creatinine ratio, low density lipoprotein, yearly dilated eye exam, yearly flu shot, and yearly diabetic foot exam.
- PHQ-2 and PHQ-0 Depression screening tool [ Time Frame: Every three months, up to 1 year ]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.
- Blood pressure [ Time Frame: Every 3 months, up to 1 year ]Assessment of blood pressure at each visit, with goal for improvement in blood pressure control.
- BMI [ Time Frame: Every 3 months, up to 1 year ]Participants will have height and weight measured at each visit which allows for calculation of BMI
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836015
|United States, Nebraska|
|Omaha, Nebraska, United States, 68131|
|Principal Investigator:||Leslie A Eiland, MD||University of Nebraska|