NCT02957721

Brief Summary

The following are hypothesized:

  1. 1.The Diabetes Engagement and Activation Platform (DEAP) can be integrated into primary care workflow to facilitate the care of patients with type 2 diabetes.
  2. 2.The DEAP intervention will be feasible and acceptable to patients with type 2 diabetes.
  3. 3.The DEAP intervention will enhance patient activation and improve type 2 diabetes self management and glucose control

Trial Health

87
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

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

October 28, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 8, 2016

Completed
12 months until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2018

Completed
Last Updated

November 9, 2018

Status Verified

November 1, 2018

Enrollment Period

1 year

First QC Date

October 28, 2016

Last Update Submit

November 7, 2018

Conditions

Type 2 Diabetes (T2D)

Outcome Measures

Primary Outcomes (1)

  • Change in A1C

    The A1C test is a blood test that provides information about a person's average levels of blood glucose, also called blood sugar, over the past 3 months. The A1C test is sometimes called the hemoglobin A1c, HbA1c, or glycohemoglobin test.

    From date of study enrollment A1C will be retrieved from electronic health record (EHR) at baseline, 3 and 6 months after enrollment. Data will continue to be collected at these intervals on all participants until target sample of 160 is complete.

Secondary Outcomes (3)

  • Patient Activation Measure (PAM 10)

    From date of study enrollment PAM 10 will be retrieved from patient portal at baseline, 3 and 6 months following enrollment. Data will continue to be collected at these intervals on all participants until target sample of 160 is complete.

  • Body Mass Index (BMI)

    From date of study enrollment BMI will be retrieved from EHR at baseline, three and six months following enrollment. Data will continue to be collected at these intervals on all participants until target sample of 160 is complet

  • Blood Pressure (BP)

    From date of study enrollment BP will be retrieved from EHR at baseline, 3 and 6 months following enrollment. Data will continue to be collected at these intervals on all participants until target sample of 160 is complete.

Study Arms (2)

Behavioral self-management

OTHER

Eligible patients who are registered on the practice EHR linked portal will be invited to join the study. Following informed consent, enrollment and randomization, participants in the treatment group will receive the type 2 diabetes behavioral self-management education intervention; comprised of 9 modules derived from Medline Plus.

Other: Usual Care

Usual Care

NO INTERVENTION

Usual care includes whatever care and services the patient's clinical provides as well as generic type 2 diabetes education built into the patient's EHR linked portal.

Interventions

Usual CareOTHER

Patients will not be given the intervention but receive usual care for T2D.

Behavioral self-management

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with type 2 diabetes and A1C measure ≥ 8%;
  • English speaking;
  • Enrolled in the practice EHR linked patient portal.

You may not qualify if:

  • Patients without type 2 diabetes or with type 2 diabetes who have a A1C less than or equal to 7.9%;
  • Non-English speaking;
  • Patients not enrolled in the practice EHR linked patient portal;
  • Under 18 and over 75 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

  • Sabo R, Robins J, Lutz S, Kashiri P, Day T, Webel B, Krist A. Diabetes Engagement and Activation Platform for Implementation and Effectiveness of Automated Virtual Type 2 Diabetes Self-Management Education: Randomized Controlled Trial. JMIR Diabetes. 2021 Mar 29;6(1):e26621. doi: 10.2196/26621.

    PMID: 33779567DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Alexander H Krist, MD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2016

First Posted

November 8, 2016

Study Start

November 1, 2017

Primary Completion

November 5, 2018

Study Completion

November 5, 2018

Last Updated

November 9, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)