Point-of-care Health Literacy and Activation Information to Improve Diabetes Care
Completed · Not applicable
Conditions studied: Diabetes Mellitus
In brief
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.
Key facts
- Study ID
- NCT01876485
- Run by
- VA Office of Research and Development
- People needed
- 280
- Starts
- 2015-07-13
- Expected to finish
- 2018-02-09
- Last updated by the study team
- 2019-06-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Veterans receiving primary care at VA study sites who are enrolled in the panels of participating primary care teams
- Veterans with ICD-9-CM and/or ICD-10 codes indicating a diagnosis of diabetes
- Veterans with an average HbA1c level > 8% in the prior 6 months
You may not qualify if…
- The investigators will exclude Veterans with the following clinical conditions that would render participation in a group clinic inappropriate:
- metastatic cancer or receiving hospice care
- limited life expectancy
- clinician recommendations to not titrate therapy due to prior history of significant hypoglycemic events
- age <18 years
- active bipolar or psychotic disorder
- The investigators will also exclude Veterans, who at the time of screening:
- cannot attend monthly group clinic sessions due to transportation or availability barriers
- have significant cognitive impairment
- have active substance-abuse disorders
- are not comfortable discussing their health and health care in a peer-group setting Patients will be secondarily excluded if their HbA1C level falls below 7.5% at baseline.
Where it is running
- Jesse Brown VA Medical Center, Chicago, IL — Chicago, Illinois, United States
- Edward Hines Jr. VA Hospital, Hines, IL — Hines, Illinois, United States
- Michael E. DeBakey VA Medical Center, Houston, TX — Houston, Texas, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.