Integrated Second Language Learning for Chronic Care

Diabetes Mellitus Clinical Trial

— ISLL  

Official title:

Integrated Second Language Learning for Chronic Care: A Model to Improve Primary Care for Hispanics With Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02864160
• Other study ID #: 60045178
• Secondary ID: R01DK104648
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: September 2019

Study information

• Verified date: March 2023
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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).
• Comparison Group
Written educational materials; self-management tools (stretch band, a glucometer, and a diabetes cookbook in Spanish).

Locations

Country	Name	City	State
United States	The Ohio State University College of Arts and Sciences	Columbus	Ohio
United States	University of Arizona College of Nursing	Tucson	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
Ohio State University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Arizona

Country where clinical trial is conducted

United States, 

References & Publications (1)

Menon U, Szalacha LA, Martinez GA, Graham MC, Pares-Avila JA, Rechenberg K, Stauber LS. Efficacy of a language-concordant health coaching intervention for latinx with diabetes. Patient Educ Couns. 2022 Jul;105(7):2174-2182. doi: 10.1016/j.pec.2021.11.024. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Program Acceptability from Baseline to End of Year 5	Qualitative interviews with academic faculty reported as qualitative themes.	From baseline to end of Year 5
Other	Change in Program Reach to End of Year 5	Number of students by academic program reported as numbers.	From baseline to end of Year 5
Primary	Change in Patient Hemoglobin A1C from Baseline to 6 Months	Hemoglobin A1C is measured via a blood test and measures the patient's average plasma glucose concentration over the past 3 months and is reported as a percentage. In general, normal A1C levels for people without diabetes is 4% to 5.6% while a level of 5.7% of 6.4% indicates prediabetes, and 6.5% or above indicates diabetes.	From baseline to 6 months
Secondary	Change in Patient Self-Efficacy from Baseline to 6 Months as Assessed by the DSES	Numerical score measured by the Diabetes Self-Efficacy Scale (DSES) which measures self-perceptions held by people with diabetes about their personal competence, power, and resourcefulness for successfully managing their diabetes. The scale has eight 10-point Likert-type items with lower scores indicative of higher self-efficacy, as defined by Grossman et al. (1987).; Grossman HY, Brink S, Hauser ST. Self-efficacy in adolescent girls and boys with insulin-dependent diabetes mellitus. Diabetes care 1987;10(3):324-9.	From baseline to 6 months
Secondary	Change in Patient Depression from Baseline to 6 Months as Assessed by the PHQ-9	Numerical score measured by the Patient Health Question-9 questionnaire which measures depression severity with Likert-type items ranging from 0 (not at all) to 4 (everyday), with higher scores indicative of greater depression. A score between 10 and 14 indicates moderate depression as defined by Spitzer et al. (2000).; Spitzer RL, Williams JB, Kroenke K, Hornyak R, McMurray J. Validity and utility of the PRIME-MD patient health questionnaire in assessment of 3000 obstetric- gynecologic patients: the PRIME-MD Patient Health Questionnaire Obstetrics- Gynecology Study. Am J Obstet Gynecol 2000;183(3):759-69.	From baseline to 6 months
Secondary	Change in Patient Anxiety from Baseline to 6 Months as Assessed by the GAD-7	Numerical score measured by the Generalized Anxiety Disorder questionnaire, a 7-item, 4-point Likert-type scale ranging from (0) Not at all to (3) Every day, with higher scores indicating greater functional impairment related to the patient's experience of anxiety. A score of greater than or equal to 10 indicates moderate anxiety, as defined by Spitzer et al. (2006).; Spitzer RL, Kroenke K, Williams JBW, Löwe B. A Brief Measure for Assessing Generalized Anxiety Disorder: The GAD-7. Arch Intern Med. 2006;166(10):1092-1097.	From baseline to 6 months
Secondary	Change in Patient Blood Pressure from Baseline to 6 Months	Measured in mmHG. Normal blood pressure for most adults is defined as a systolic pressure of less than 120 and a diastolic pressure of less than 80. Elevated blood pressure is defined as a systolic pressure between 120 and 129 with a diastolic pressure of less than 80.	From baseline to 6 months
Secondary	Change in Patient Weight from Baseline to 6 Months	Measured in pounds and ounces	From baseline to 6 months
Secondary	Change in Patient Body Mass Index from Baseline to 6 Months	Measured in weight (kg)/height (m^2). In general, a Body Mass Index (BMI) of under 18.5 falls within the underweight range, 18.5 to 24.9 falls within the normal or Healthy Weight range, 25.0 to 29.9 falls within the overweight range, and 30.0 or higher falls within the obese range.	From baseline to 6 months
Secondary	Change in Patient Waist Circumference from Baseline to 6 Months	Measured in inches.	From baseline to 6 months
Secondary	Change in Patient Total Cholesterol from Baseline to 6 Months	Milligrams per deciliter of blood (mg/dL) that is reported as a whole number. In general, less than 200 mg/dL is considered normal, 200 to 239 mg/dL is borderline high, and at or above 240 mg/dL is high.	From baseline to 6 months
Secondary	Change in Health Coach Spanish Language Proficiency from Baseline to 6 Months as Assessed by the ACTFL	Standardized Oral Proficiency score American Council on the Teaching of Foreign Languages (ACTFL) 2012 proficiency scale. Levels range from Distinguished (highest), Superior, Advanced, Intermediate, and Novice (lowest).	From baseline to 6 months
Secondary	Change in Health Coach Interpersonal Communication from Baseline to 6 Months as Assessed by the RIAS	Numerical score measured by the Roter Interaction Analysis System (RIAS).	From baseline to 6 months