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Integrated Second Language Learning for Chronic Care (ISLL)

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ClinicalTrials.gov Identifier: NCT02864160
Recruitment Status : Recruiting
First Posted : August 11, 2016
Last Update Posted : January 21, 2019
Sponsor:
Collaborators:
University of Arizona
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Glenn Martinez, Ohio State University

Brief Summary:
Language barriers continue to impede access to quality care for limited English proficient populations. Recent research has demonstrated that access to language concordant providers increases quality of care. This project evaluates the efficacy and acceptability of a model intervention to improve second language proficiency, patient-centered communication, and clinical competency of nurse practitioner students who care for Spanish-speaking patients with diabetes.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Behavioral: Health Coaching Behavioral: Comparison Group Not Applicable

Detailed Description:

The purpose of this randomized controlled 2-group study is to test the effect of an innovative educational intervention called Integrated Language Learning for Chronic Care (IL2L) on successful self-management of diabetes. It pursues an integrated development of second language and interpersonal communication skills that will facilitate productive interactions between Spanish-speaking nurse practitioners (NP) and limited English proficiency Hispanic patients with diabetes. The intervention targets the acquisition of language skills that facilitate communicative functions known to be effective in engaging chronically ill patients. It accelerates acquisition of these skills by adding a longitudinal clinical instruction dimension. Further, the investigators propose that the efficacy of the intervention can be demonstrated at the provider level through improved linguistic and interpersonal performance and at the patient level through improved diabetes outcomes in response to language concordance. In support of these claims, the investigators seek to achieve the following specific aims:

Aim 1: To determine the efficacy of the IL2L for Chronic Care intervention on physical and mental health outcomes for Spanish-speaking patients with diabetes. Our hypothesis is: H1: Patients in the IL2L care group will report better physical health (HbA1C, lipids, and weight), mental health (depression and anxiety) and satisfaction with their healthcare than patients in the non-IL2L care group.

Aim 2: To determine the efficacy of the IL2L for Chronic Care intervention on provider language proficiency and interpersonal communication skills. Our hypothesis is:H2: Providers exposed to the IL2L intervention will demonstrate improved Spanish language skills and interpersonal communication skills upon completion of the intervention.Specific Aim 3: To assess the acceptability of the IL2L for Chronic Care model within a graduate level nurse practitioner curriculum in a leading College of Nursing.

The study will employ a mixed-methods model to assess the efficacy and accessibility of the IL2L for Chronic Care educational intervention in The Ohio State University's College of Nursing nurse practitioner program. To achieve Aim 1, the investigators will use a randomized control trial to demonstrate efficacy of the IL2L for Chronic Care model at the patient level. The investigators will compare a group of patients exposed to providers who underwent the IL2L intervention (intervention group) and a group of patients who are undergoing standard care (comparison group). To achieve Aim 2, the investigators will use a qualitative data interaction analysis system to demonstrate improvement in Spanish language proficiency and interpersonal communication skills. To achieve Aim 3, the investigators will use a combination of quantitative and qualitative measures within the RE-AIM model to assess the acceptability of the IL2L for chronic care model at the program level in a nurse practitioner program in a leading College of Nursing. The study has been approved by the institutional review boards of both universities prior to implementation and patients and student providers provide written informed consent.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Integrated Second Language Learning for Chronic Care: A Model to Improve Primary Care for Hispanics With Diabetes
Actual Study Start Date : September 2014
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : September 2019

Arm Intervention/treatment
Experimental: Health Coaching
The health coaching intervention group (n=100) will receive written educational materials on diabetes self-management in Spanish and the diabetes self-management tools (stretch band, a glucometer, and a diabetes cookbook in Spanish). In addition, patients in the intervention group will be assigned a health coach who will provide health coaching over the course of 6 months with 14 phone calls.
Behavioral: Health Coaching
Life style coaching in 3 in-person meetings and 14 phone calls; written educational materials; self-management tools (stretch band, a glucometer, and a diabetes cookbook in Spanish).

Active Comparator: Comparison group
The comparison group (n=100) will receive the standard diabetes care that is offered at Heart of Ohio clinics including consultations with a primary care provider, a dietician, a pharmacist, and a diabetes educator. The comparison group will receive written educational materials on diabetes self-management in Spanish and diabetes self-management tools including a stretch band, a glucometer, and a diabetes cookbook in Spanish.
Behavioral: Comparison Group
Written educational materials; self-management tools (stretch band, a glucometer, and a diabetes cookbook in Spanish).




Primary Outcome Measures :
  1. Change in Patient Hemoglobin A1C [ Time Frame: From baseline to 6 months ]
    Percentage of average plasma glucose concentration over 3 months that is reported as a percentage.


Secondary Outcome Measures :
  1. Change in Patient Self-Efficacy [ Time Frame: From baseline to 6 months ]
    Numerical score measured by the Diabetes Self-Management questionnaire.

  2. Change in Patient Depression [ Time Frame: From baseline to 6 months ]
    Numerical score measured by the Patient Health Question-9 questionnaire.

  3. Change in Patient Anxiety [ Time Frame: From baseline to 6 months ]
    Numerical score measured by the Generalized Anxiety Disorder questionnaire..

  4. Change in Patient Medication Adherence [ Time Frame: From baseline to 6 months ]
    Numerical score measured by the Morisky Medication Adherence questionnaire

  5. Change in Patient Blood Pressure [ Time Frame: From baseline to 6 months ]
    Measured in mmHG.

  6. Change in Patient Weight [ Time Frame: From baseline to 6 months ]
    Measured in pounds and ounces

  7. Change in Patient BMI [ Time Frame: From baseline to 6 months ]
    Measured in kg/m^2.

  8. Change in Patient Waist Circumference [ Time Frame: From baseline to 6 months ]
    Measured in inches.

  9. Change in Patient Total Cholesterol [ Time Frame: From baseline to 6 months ]
    Milligrams per deciliter of blood (mg/dL) that is reported as a whole number.

  10. Change in Health Coach Spanish Language Fluency [ Time Frame: From baseline to 6 months ]
    Standardized Oral Proficiency score.

  11. Change in Health Coach Interpersonal Communication [ Time Frame: From baseline to 6 months ]
    Numerical score measured by the Roter Interaction Analysis System-RIAS.


Other Outcome Measures:
  1. Change in Program Acceptability [ Time Frame: From baseline to end of Year 5 ]
    Qualitative interviews with academic faculty reported as qualitative themes.

  2. Change in Program Reach [ Time Frame: From baseline to end of Year 5 ]
    Number of students by academic program reported as numbers.



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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA

Students:

Enrolled in nurse practitioner programs at Ohio State University or University of Arizona Minimum intermediate Spanish language fluency by Oral Proficiency testing Patients Self identify as Hispanic/Latino Self identify preference for health care interaction in Spanish Clinical diagnosis of Type 2 diabetes Hemoglobin A1C of 7 or higher 22 years or older Must have access to land line or mobile phone

EXCLUSION CRITERIA

Students:

Distinguished Spanish language fluency by Oral Proficiency testing Received professional training for a health-related profession in a Spanish-speaking country

Patients:

Clinic diagnosis of diabetic retinopathy, diabetic neuropathy, or diabetic nephropathy Clinical diagnosis of major depression Clinical diagnosis of other psychiatric disorder


Information from the National Library of Medicine

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): NCT02864160


Contacts
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Contact: Estephanie Ortiz, BA 6146882126 ortiz.115@osu.edu
Contact: Usha Menon, PhD 520-626-0828 umenon@email.arizona.edu

Locations
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United States, Arizona
University of Arizona College of Nursing Recruiting
Tucson, Arizona, United States, 85724
Contact: Usha Menn, PhD    520-626-0828    umenon@email.arizona.edu   
Contact: Dianna Candito    520-626-3628    dcandito@email.arizona.edu   
United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43201
Contact: Estephanie Ortiz, BA    614-688-2126    ortiz.115@osu.edu   
Contact: Usha Menon, PhD    520-626-0828    umenon@email.arizona.edu   
Principal Investigator: Usha Menon, PhD, RN         
Principal Investigator: Glenn A Martinez, PhD, MPH         
Sub-Investigator: Laura A Szalacha, EdD         
Sub-Investigator: Margaret Graham, PhD, CRNP         
Sub-Investigator: Jose Pares Avila, PhD         
Sponsors and Collaborators
Ohio State University
University of Arizona
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Usha Menon, PhD, RN, The University of Arizona College of Nursing
Principal Investigator: Glenn A Martinez, PhD, MPH Department of Spanish and Portuguese at The Ohio State University

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Responsible Party: Glenn Martinez, Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT02864160     History of Changes
Other Study ID Numbers: 60045178
R01DK104648 ( U.S. NIH Grant/Contract )
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: January 21, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data will be available to share with students and faculty on request to the Principal Investigators if IRB approves the secondary analysis project.

Keywords provided by Glenn Martinez, Ohio State University:
Language Concordance
Diabetes Self-Management
Health Coaching
Latinos

Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases