The EMPATHy Toolkit: Helping Diabetes Patients Overcome Barriers to Medication Adherence

NCT ID: NCT02324036

Last Updated: 2015-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-08-31

Brief Summary

The proposed study is a pilot study to gather data on the effectiveness and feasibility of a software tool (EMPATHy) to help patients communicate effectively with doctors about problems they face with their medication regimens. EMPATHy will be incorporated into an existing clinic-based intervention called Coached Care, in which community health workers (CHWs, non-professional community members) work as a "Coach" to patients to help them improve engagement and communication during the medical visit.

Detailed Description

Low income, Mexican American patients with diabetes exhibit high rates of medication nonadherence, which results in poor blood sugar control and serious complications, and often have difficulty communicating their concerns about the medication regimen to physicians. Interventions led by community health workers (CHWs), non-professional community members who are trained to work with patients to improve engagement and communication during the medical visit, have had mixed success in improving outcomes. Although CHWs possess excellent cultural competency and are very effective at establishing rapport with patients, they often lack a sophisticated understanding of all the potential challenges that can come with following a regimen. The primary objective of this project is to develop and pilot test a prototype software toolkit called "EMPATHy" that a CHW can administer to help patients identify and articulate the most important barriers to adherence that they face.

The EMPATHy toolkit will be piloted in an ongoing intervention (Coached Care) in which CHWs are trained to be "Coaches" to meet with patients before the medical visit, and help them prepare a list of important questions for the doctor. The Lead Researcher (Billimek) is a co-director of this intervention program at UCI's Ambulatory Clinics, including the Family Health Center in Santa Ana ,with a highly vulnerable population-low income Mexican American patients with diabetes and a history of nonadherence. A CHW will be trained to use two commercially available software programs configured by the PI to deliver the intervention materials. Patients participating in Coached Care (which is a clinic- based intervention, not a research protocol) will be recruited to (1) complete a Coached Care intervention session that has been modified to incorporate the EMPATHy Toolkit, (2) answer questions about barriers to medication adherence and the feasibility/usability of the software (3) allow the research team to abstract data on the medication regimen and diabetes outcomes (hemoglobin A1c, LDL cholesterol, etc) from the patient's medical record.

Conditions

Diabetes Mellitus, Type 2

Study Design

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

Study Groups

Coached Care+EMPATHy;

EMPATHy Toolkit: Patient coaching with computer assisted preference assessment

Group Type: EXPERIMENTAL

EMPATHy Toolkit

Intervention Type: DEVICE

Software-based toolkit to help patients identify and prioritize barriers to medication adherence; community health worker provides participation training to patient

Routine Coached Care

Patient coaching only

Group Type: ACTIVE_COMPARATOR

Coached Care

Intervention Type: BEHAVIORAL

Community health worker provides participation training to patient

Interventions

EMPATHy Toolkit

Software-based toolkit to help patients identify and prioritize barriers to medication adherence; community health worker provides participation training to patient

Intervention Type: DEVICE

Coached Care

Community health worker provides participation training to patient

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. age 18 and older;

2. have poorly controlled type 2 diabetes (as indicated by HbA1c>7.5%, LDL cholesterol >100 mg/dl or systolic blood pressure > 140),

3. be of Hispanic ethnicity,

4. speak English or Spanish.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

John Thomas Billimek

Assistant Adjunct Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John Billimek, PhD

Role: PRINCIPAL_INVESTIGATOR

Irvine

Locations

Health Policy Research Institute

Irvine, California, United States

Countries

United States

References

Billimek J, Guzman H, Angulo MA. Effectiveness and feasibility of a software tool to help patients communicate with doctors about problems they face with their medication regimen (EMPATHy): study protocol for a randomized controlled trial. Trials. 2015 Apr 10;16:145. doi: 10.1186/s13063-015-0672-7.

Reference Type: BACKGROUND

PMID: 25873349 (View on PubMed)

Other Identifiers

2014-1442

Identifier Type: -

Identifier Source: org_study_id