NCT01876485

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable diabetes-mellitus

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2013

Completed
2.1 years until next milestone

Study Start

First participant enrolled

July 13, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2018

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

June 19, 2019

Completed
Last Updated

June 19, 2019

Status Verified

March 1, 2019

Enrollment Period

2.6 years

First QC Date

June 10, 2013

Results QC Date

November 29, 2018

Last Update Submit

March 19, 2019

Conditions

Diabetes Mellitus

Keywords

Diabetes Mellitushealth literacypatient activationgoals of care

Outcome Measures

Primary Outcomes (2)

  • Changes in Percent Glycosylated Hemoglobin (HbA1c) Levels During Intervention

    Measures of HbA1c will be taken to assess average blood glucose levels throughout the study as an indicator of diabetes control.

    HbA1c levels will be measured at baseline, four months, and ten months.

  • Change in Diabetes Specific Quality of Life

    The Diabetes Distress Scale (DDS) will be used to assess diabetes quality of life throughout the study. Minimum value: 1; Maximum value: 6. Higher scores indicate a higher level of diabetes distress.

    Diabetes specific quality of life will be measured at baseline, four months, and ten months.

Study Arms (2)

Arm 1: Empowering Patients in Chronic Care (EPIC)

EXPERIMENTAL

Patients in the intervention arm will receive the Empowering Patients in Chronic Care 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: Empowering Patients in Chronic Care (EPIC)

Arm 2: Enhanced Usual Care (EUC)

ACTIVE COMPARATOR

The Enhanced Usual Care (EUC) arm will serve as a concurrent control group to compare to the intervention arm of the study. 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.

Behavioral: Enhanced Usual Care (EUC)

Interventions

Empowering Patients in Chronic Care (EPIC)BEHAVIORAL

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.

Arm 1: Empowering Patients in Chronic Care (EPIC)
Enhanced Usual Care (EUC)BEHAVIORAL

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.

Arm 2: Enhanced Usual Care (EUC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Jesse Brown VA Medical Center, Chicago, IL

Chicago, Illinois, 60612, United States

Location

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, 60141-5000, United States

Location

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030, United States

Location

Related Publications (4)

  • Arney J, Thurman K, Jones L, Kiefer L, Hundt NE, Naik AD, Woodard LD. Qualitative findings on building a partnered approach to implementation of a group-based diabetes intervention in VA primary care. BMJ Open. 2018 Jan 21;8(1):e018093. doi: 10.1136/bmjopen-2017-018093.

    PMID: 29358425RESULT

  • Woodard LD, Adepoju OE, Amspoker AB, Virani SS, Ramsey DJ, Petersen LA, Jones LA, Kiefer L, Mehta P, Naik AD. Impact of Patient-Centered Medical Home Implementation on Diabetes Control in the Veterans Health Administration. J Gen Intern Med. 2018 Aug;33(8):1276-1282. doi: 10.1007/s11606-018-4386-x. Epub 2018 Apr 2.

    PMID: 29611089RESULT

  • Banks J, Amspoker AB, Vaughan EM, Woodard L, Naik AD. Ascertainment of Minimal Clinically Important Differences in the Diabetes Distress Scale-17: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Nov 1;6(11):e2342950. doi: 10.1001/jamanetworkopen.2023.42950.

    PMID: 37966840DERIVED

  • Woodard L, Amspoker AB, Hundt NE, Gordon HS, Hertz B, Odom E, Utech A, Razjouyan J, Rajan SS, Kamdar N, Lindo J, Kiefer L, Mehta P, Naik AD. Comparison of Collaborative Goal Setting With Enhanced Education for Managing Diabetes-Associated Distress and Hemoglobin A1c Levels: A Randomized Clinical Trial. JAMA Netw Open. 2022 May 2;5(5):e229975. doi: 10.1001/jamanetworkopen.2022.9975.

    PMID: 35507345DERIVED

MeSH Terms

Conditions

Diabetes MellitusPatient Participation

Interventions

Long-Term Care

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Dr. LeChauncy Woodard
Organization
Department of Veterans Affairs
woodard.lechauncy@va.gov
(713) 440-4441

Study Officials

  • LeChauncy D. Woodard, MD MPH

    Michael E. DeBakey VA Medical Center, Houston, TX

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2013

First Posted

June 12, 2013

Study Start

July 13, 2015

Primary Completion

February 9, 2018

Study Completion

February 9, 2018

Last Updated

June 19, 2019

Results First Posted

June 19, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

US(3)