Diabetes Mellitus Type 2SMVNCT02836015
Shared Medical Visits for Spanish-speaking Patients With Type 2 Diabetes
A study testing Shared Medical Visit in people with Diabetes Mellitus Type 2, run by University of Nebraska at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- Shared Medical Visit
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2016to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients over the age of eighteen years old with Type 2 diabetes
- HgbA1c greater than 8%
- Preferred language is Spanish
Who cannot join
- Pregnancy
- Residency at a nursing home or other facility
- Substance abuse
- Physician recommendation that study is not appropriate for the patient
Trial locations and contacts
1 site in 1 country.
United States1 site
Nebraska Medicine, Midtown Health Center
Omaha, Nebraska, 68131
About this study
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.
Read the 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.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Shared Medical Visit
- Keywords
- Shared Medical Visits, Spanish-speaking
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared Medical VisitBehavioural
Also called SMV
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.
| Study group | Role | What they receive |
|---|---|---|
| Shared Medical Visit Groups | Experimental | All patients will be enrolled in the experimental group and will be involved in shared medical visits. Receives: Behavioral: Shared Medical Visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
Every 3 months we will measure hemoglobin A1c to assess for improvement in glycemic control.
Measured: Every three months, up to 1 year
Secondary outcomes (6)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Every three months, up to 1 year
Blood pressure
Assessment of blood pressure at each visit, with goal for improvement in blood pressure control.
Measured: Every 3 months, up to 1 year
BMI
Participants will have height and weight measured at each visit which allows for calculation of BMI
Measured: Every 3 months, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study start13 May 2016
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leslie A Eiland, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02836015
- Sponsor's protocol ID
- 0146-16-EP
- Acronym
- SMV
- Status last verified
- Dec 2023
- First submitted
- 23 May 2016
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25107290Trento 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.
PubMed 11375359McCloskey 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.
PubMed 20860336Ramal 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.
PubMed 22427108Pyatak 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.
PubMed 24867918Ell 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.
PubMed 20097780Bohn 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.
PubMed 20128205Jaber 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.
PubMed 16672681Gutierrez 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.
PubMed 21756014
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Medical Visits for Spanish-speaking Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02836015
- Acronym / sponsor ID
- SMV / 0146-16-EP
- Conditions
- Diabetes Mellitus Type 2
- Keywords
- Shared Medical Visits, Spanish-speaking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 13 May 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 18 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shared Medical Visit Groups | Experimental | Behavioral: Shared Medical VisitAll patients will be enrolled in the experimental group and will be involved in shared medical visits. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients over the age of eighteen years old with Type 2 diabetes
- HgbA1c greater than 8%
- Preferred language is Spanish
Key exclusion criteria (4 listed)
- Pregnancy
- Residency at a nursing home or other facility
- Substance abuse
- Physician recommendation that study is not appropriate for the patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shared Medical VisitAlso: SMVThe 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. | Behavioural | Shared Medical Visit Groups |
Primary outcome
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.
6 secondary outcomes
Improvement in self care behaviors
Time frame: Every three months, up to 1 year
Barriers to care for Spanish-speaking patients with diabetes
Time frame: Every 3 months, up to 1 year
Screening for complications of diabetes
Time frame: Once annually, up to 1 year
PHQ-2 and PHQ-0 Depression screening tool
Time frame: Every three months, up to 1 year
Blood pressure
Time frame: Every 3 months, up to 1 year
BMI
Time frame: Every 3 months, up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2023.
- Background: PubMed 25107290Edelman 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.
- Background: PubMed 11375359Trento 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.
- Background: PubMed 20860336McCloskey 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.
- Background: PubMed 22427108Ramal 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.
- Background: PubMed 24867918Pyatak 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.
- Background: PubMed 20097780Ell 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.
- Results publication: PubMed 20128205Bohn 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.
- Results publication: PubMed 16672681Jaber 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.
- Results publication: PubMed 21756014Gutierrez 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.
- Diabetes Initiative: a National Program of The Robert Wood Johnson FoundationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leslie A Eiland, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shared Medical Visit in people with Diabetes Mellitus Type 2, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1c (time frame: Every three months, up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02836015, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2023.