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Point-of-care Health Literacy and Activation Information to Improve Diabetes Care

NCT01876485 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2019-06-19

Study results available
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Summary

This hybrid effectiveness/implementation trial will be conducted in two phases over four years. In Phase 1, the investigators will evaluate the process of implementing a collaborative, diabetes goal-setting intervention (Empowering Patients in Chronic Care \[EPIC\]) personalized to self-reported patient activation and functional health literacy (FHL) levels into routine primary care practices. In Phase 2, the investigators will conduct a randomized, clinical trial to compare the effectiveness of EPIC to enhanced usual care (EUC). In Phase 2, the investigators will conduct a randomized clinical trial enrolling 284 Veterans with poorly controlled diabetes defined by average hemoglobin A1c over the last six months of \>= 8% to receive EPIC or enhanced usual care (EUC). Consented subjects will be allocated evenly between EPIC and EUC. EPIC consists of six 1-hour group sessions focusing on 1) Your Health, Your Values, 2) Diabetes ABCs, 3) Setting Goals and Making Action Plans, 4) Communication with Your Health Care Provider, 5) Staying Committed to Your Goals, and 6) Reviewing and Planning for the Future. After each group session, a one-on-one session between a designated PACT member and patient participants will focus on collaborative goal-setting. Patients randomized to EUC will be referred to the PACT RN Care Manager for diabetes management, and will also receive a packet of educational materials regarding diabetes management, including a letter delineating the diabetes management resources available at their facility. Study measurements using self-reported questionnaires and blood tests to assess blood sugar control will be obtained at baseline, post-intervention, and post-six month maintenance period.

Conditions

Interventions

BEHAVIORAL

Empowering Patients in Chronic Care (EPIC)

EPIC group training sessions consisting of 6 one-hour group sessions occurring over a 6-month period. Group sessions will consist of behavioral coaching focused on diabetes management. Following each group-session, patients enrolled in the intervention arm will meet with a designated member of their primary care team to personalize diabetes goals and action plans.

BEHAVIORAL

Enhanced Usual Care (EUC)

Patients randomized to EUC will be referred to the PACT RN Care Manager for diabetes management, and will also receive a packet of educational materials regarding diabetes management, including a letter delineating the diabetes management resources available at their facility.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • LeChauncy D. Woodard, MD MPH · Michael E. DeBakey VA Medical Center, Houston, TX

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-13
Primary Completion
2018-02-09
Completion
2018-02-09

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01876485 on ClinicalTrials.gov