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

NCT02324036 | Completed Early Phase 1

• 1 other identifier: 2014-1442
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• Development of a contextualized plan of care (assessed by analyzing an audio recording of the medical visit)

  Development of a contextualized plan of care will be assessed by analyzing an audio recording of the medical visit, using a previously developed coding scheme (see Research Methodology). If the coder concludes that the plan of care discussed in the visit adequately addresses a contextual factor raised during the visit, it will be determined that a contextualized plan of care was developed.

  Baseline

• Attainment of concrete behavioral goal (assessed in a two-week follow-up phone call to the patient)

  Attainment of concrete behavioral goal will be assessed in a two-week follow-up phone call to the patient, and will be defined as the patient reporting having completed the specific action that he or she specified with the Coach as a concrete goal during the intervention post-visit.

  2 weeks post visit

Secondary Outcomes (2)

• Discussion of a contextual factor in the visit (assessed from audio recordings of the visit)

  Baseline

• Improvement in "red flag" outcome (assessed from the patient's medical record as the change in the measured value of the outcome measure identified as a high priority outcome)

  6 months post visit

Study Arms (2)

Coached Care+EMPATHy;

EXPERIMENTAL

EMPATHy Toolkit: Patient coaching with computer assisted preference assessment

Device: EMPATHy Toolkit

Routine Coached Care

ACTIVE COMPARATOR

Patient coaching only

Behavioral: Coached Care

Interventions

EMPATHy Toolkit DEVICE

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

Coached Care+EMPATHy;

Coached Care BEHAVIORAL

Community health worker provides participation training to patient

Routine Coached Care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 and older;
• have poorly controlled type 2 diabetes (as indicated by HbA1c\>7.5%, LDL cholesterol \>100 mg/dl or systolic blood pressure \> 140),
• be of Hispanic ethnicity,
• speak English or Spanish.

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

Health Policy Research Institute

Irvine, California, 92697, United States

Location

Related Publications (1)

• 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.

  PMID: 25873349 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Officials

• John Billimek, PhD

  Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Adjunct Professor

Study Record Dates

• First Submitted: December 16, 2014
• First Posted: December 24, 2014
• Study Start: December 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: August 1, 2015
• Last Updated: December 2, 2015

Record last verified: 2015-11

Locations

US (1)