Integrated Second Language Learning for Chronic Care

NCT02864160 | Completed

• 2 other identifiers: 60045178R01DK104648
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes Mellitus

Keywords

Language Concordance; Diabetes Self-Management; Health Coaching; Latinos

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Change in Patient Self-Efficacy from Baseline to 6 Months as Assessed by the DSES

  From baseline to 6 months

• Change in Patient Depression from Baseline to 6 Months as Assessed by the PHQ-9

  From baseline to 6 months

• Change in Patient Anxiety from Baseline to 6 Months as Assessed by the GAD-7

  From baseline to 6 months

• Change in Patient Blood Pressure from Baseline to 6 Months

  From baseline to 6 months

• Change in Patient Weight from Baseline to 6 Months

  From baseline to 6 months

Other Outcomes (2)

• Change in Program Acceptability from Baseline to End of Year 5

  From baseline to end of Year 5

• Change in Program Reach to End of Year 5

  From baseline to end of Year 5

Study Arms (2)

Health Coaching

EXPERIMENTAL

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

Comparison group

ACTIVE COMPARATOR

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

Interventions

Health Coaching 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).

Health Coaching

Comparison Group BEHAVIORAL

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

Comparison group

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead
• University of Arizona: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

University of Arizona College of Nursing

Tucson, Arizona, 85724, United States

Location

The Ohio State University College of Arts and Sciences

Columbus, Ohio, 43201, United States

Location

Related 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. Epub 2021 Nov 28.

  PMID: 34895775 RESULT

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Usha Menon, PhD, RN,

  University of South Florida College of Nursing

  PRINCIPAL INVESTIGATOR

• Glenn A Martinez, PhD, MPH

  The University of Texas at San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 group study with concurrrent random assignment to intervention or control group using random assignment list that was pre-generated

Study Record Dates

• First Submitted: August 3, 2016
• First Posted: August 11, 2016
• Study Start: September 1, 2014
• Primary Completion: July 31, 2019
• Study Completion: September 1, 2019
• Last Updated: March 9, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, ANALYTIC CODE
• Time Frame: Data requests can be submitted starting 6 months after article publication and the data will be made accessible for up to four years. Extensions will be considered on a case-by-case basis.
• Access Criteria: Access to de-identified Individual Participant Data from this trial can be requested if the requestor obtains the appropriate clearance from their Institutional Review Board for the secondary analysis project and if the requestor is willing to complete a Data Sharing Agreement. For more information or to submit a request, please contact Dr. Usha Menon at umenon@usf.edu.

Locations

US (2)