Diabetes MellitusISLLNCT02864160
Integrated Second Language Learning for Chronic Care
A study testing Health Coaching and Comparison Group in people with Diabetes Mellitus, run by Ohio State University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Health Coaching and Comparison Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2014to Sep 2019
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Ohio State University College of Arts and Sciences
Columbus, Ohio, 43201
University of Arizona College of Nursing
Tucson, Arizona, 85724
About this study
Official title: Integrated Second Language Learning for Chronic Care: A Model to Improve Primary Care for Hispanics With Diabetes
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.
Read the 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
- Being tested
- Health Coaching, Comparison Group
- Keywords
- Language Concordance, Diabetes Self-Management, Health Coaching, Latinos
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health CoachingBehavioural
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 GroupBehavioural
Written educational materials; self-management tools (stretch band, a glucometer, and a diabetes cookbook in Spanish).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Comparison Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to 6 months
Secondary outcomes (10)
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.
Measured: From baseline to 6 months
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.
Measured: From baseline to 6 months
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.
Measured: From baseline to 6 months
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.
Measured: From baseline to 6 months
Change in Patient Weight from Baseline to 6 Months
Measured in pounds and ounces
Measured: From baseline to 6 months
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.
Measured: From baseline to 6 months
Change in Patient Waist Circumference from Baseline to 6 Months
Measured in inches.
Measured: From baseline to 6 months
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.
Measured: From baseline to 6 months
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).
Measured: From baseline to 6 months
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).
Measured: From baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startSep 2014
- Primary completion31 Jul 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 group study with concurrrent random assignment to intervention or control group using random assignment list that was pre-generated
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Arizona, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Usha Menon, PhD, RN,, Principal investigator, University of South Florida College of NursingGlenn A Martinez, PhD, MPH, Principal investigator, The University of Texas at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02864160
- Sponsor's protocol ID
- 60045178
- Other IDs
- R01DK104648
- Acronym
- ISLL
- Status last verified
- Mar 2023
- First submitted
- 3 Aug 2016
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data obtained through this study will be available upon request to share with qualified students and faculty engaging in independent scientific research.
Publications
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.
PubMed 34895775
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Second Language Learning for Chronic Care: A Model to Improve Primary Care for Hispanics With Diabetes
- ClinicalTrials.gov ID
- NCT02864160
- Acronym / sponsor ID
- ISLL / 60045178
- Conditions
- Diabetes Mellitus
- Keywords
- Language Concordance, Diabetes Self-Management, Health Coaching, Latinos
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- University of Arizona, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Sep 2014 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 11 Aug 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 group study with concurrrent random assignment to intervention or control group using random assignment list that was pre-generated
| Arm | Type | Receives |
|---|---|---|
| Health Coaching | Experimental | Behavioral: Health CoachingThe 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. |
| Comparison group | Active comparator | Behavioral: Comparison GroupThe 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- Distinguished Spanish language fluency by Oral Proficiency testing Received professional training for a health-related profession in a Spanish-speaking country
- Clinic diagnosis of diabetic retinopathy, diabetic neuropathy, or diabetic nephropathy Clinical diagnosis of major depression Clinical diagnosis of other psychiatric disorder
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 |
|---|---|---|
| Health CoachingLife 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). | Behavioural | Health Coaching |
| Comparison GroupWritten educational materials; self-management tools (stretch band, a glucometer, and a diabetes cookbook in Spanish). | Behavioural | Comparison group |
Primary outcome
Change in Patient Hemoglobin A1C from Baseline to 6 Months
Time frame: 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.
10 secondary outcomes
Change in Patient Self-Efficacy from Baseline to 6 Months as Assessed by the DSES
Time frame: From baseline to 6 months
Change in Patient Depression from Baseline to 6 Months as Assessed by the PHQ-9
Time frame: From baseline to 6 months
Change in Patient Anxiety from Baseline to 6 Months as Assessed by the GAD-7
Time frame: From baseline to 6 months
Change in Patient Blood Pressure from Baseline to 6 Months
Time frame: From baseline to 6 months
Change in Patient Weight from Baseline to 6 Months
Time frame: From baseline to 6 months
Change in Patient Body Mass Index from Baseline to 6 Months
Time frame: From baseline to 6 months
Change in Patient Waist Circumference from Baseline to 6 Months
Time frame: From baseline to 6 months
Change in Patient Total Cholesterol from Baseline to 6 Months
Time frame: From baseline to 6 months
Change in Health Coach Spanish Language Proficiency from Baseline to 6 Months as Assessed by the ACTFL
Time frame: From baseline to 6 months
Change in Health Coach Interpersonal Communication from Baseline to 6 Months as Assessed by the RIAS
Time frame: From baseline to 6 months
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 9 Mar 2023.
- Results publication: PubMed 34895775Menon 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.
- Individual participant dataSharing planned: Yes. De-identified data obtained through this study will be available upon request to share with qualified students and faculty engaging in independent scientific research.
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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.
Usha Menon, PhD, RN, principal investigator
University of South Florida College of Nursing
Glenn A Martinez, PhD, MPH principal investigator
The University of Texas at San Antonio
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Coaching and Comparison Group in people with Diabetes Mellitus, run by Ohio State University at 2 sites 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 2 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 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Change in Patient Hemoglobin A1C from Baseline to 6 Months (time frame: From baseline to 6 months). 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 NCT02864160, which also lists 1 linked publication.
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 9 Mar 2023.