Integrated Second Language Learning for Chronic Care

NCT ID: NCT02864160

Last Updated: 2023-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2019-09-30

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.

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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Health Coaching

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

Comparison Group

Intervention Type: BEHAVIORAL

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

Interventions

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).

Intervention Type: BEHAVIORAL

Comparison Group

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

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arizona

OTHER

Sponsor Role: collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Usha Menon, PhD, RN,

Role: PRINCIPAL_INVESTIGATOR

University of South Florida College of Nursing

Glenn A Martinez, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

The University of Texas at San Antonio

Locations

University of Arizona College of Nursing

Tucson, Arizona, United States

The Ohio State University College of Arts and Sciences

Columbus, Ohio, United States

Countries

United States

References

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. Epub 2021 Nov 28.

Reference Type: RESULT

PMID: 34895775 (View on PubMed)

Other Identifiers

R01DK104648

Identifier Type: NIH

Identifier Source: secondary_id

View Link

60045178

Identifier Type: -

Identifier Source: org_study_id