Diabetes Engagement and Activation Platform (DEAP)

DEAP: Diabetes Engagement and Activation Platform

The following are hypothesized:

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. The DEAP intervention will be feasible and acceptable to patients with type 2 diabetes.
3. The DEAP intervention will enhance patient activation and improve type 2 diabetes self management and glucose control

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes (T2D)
• Intervention / Treatment: Other: Usual Care

Detailed Description

Aim 1: To evaluate how primary care practices adopt and integrate DEAP into routine workflow including identification of barriers and facilitators to support acceptable, feasible, and sustainable use of the system.

• Sub-aim 1.1: Measure the proportion of clinicians and care team members who engage patients through the DEAP intervention as well as the types of patient support activities they address; assess the representativeness of participating clinicians and care team members in relation to all practice staff; and assess how they integrated DEAP into the care of type 2 diabetes patients.
• Sub-aim 1.2: Assess how practices redesign workflow, overcome barriers, and enhance facilitators in order to integrate DEAP.
• Sub-aim 1.3: Determine processes for sustaining DEAP beyond the project funding period .

Aim 2: To compare, relative to usual care, the effectiveness of the DEAP intervention.

• Sub Aim 2.1: Measure the proportion and representativeness of eligible patients who choose to enroll; access the DEAP curriculum; complete the DEAP curriculum; and contact care team members. .
• Sub Aim 2.2: Compare the change in the average glycosylated hemoglobin (primary outcome), Body Mass Index, systolic blood pressure, and type 2 diabetes (T2D) medications and patient activation (secondary outcomes) from baseline to 3 months and from 3 to 6 months for patients randomized to DEAP versus usual care.

Sub Aim 2.3: Assess the clarity, readability and acceptability of the DEAP curricula materials for T2D patients enrolled in the intervention.

• Study Type: Interventional
• Enrollment (Actual): 350
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Behavioral self-management; 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; Patients will not be given the intervention but receive usual care for T2D.
No Intervention: Usual Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Activation Measure (PAM 10)	measures how well patients self-manage diabetes.	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)	The BMI is an attempt to quantify the amount of tissue mass (muscle, fat, and bone) in an individual, and then categorize that person as underweight, normal weight, overweight, or obese based on that value.	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)	Systolic blood pressure represents the pressure in the arteries when the heart is contracting, and the pressure when the heart is at rest is called diastolic blood pressure. Blood pressure is measured using a blood pressure cuff, which is wrapped around the upper arm.	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.

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Alexander H Krist, MD, Virginia Commonwealth University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): November 5, 2018
• Study Completion (Actual): November 5, 2018

Study Registration Dates

• First Submitted: October 28, 2016
• First Submitted That Met QC Criteria: November 3, 2016
• First Posted (Estimate): November 8, 2016

Study Record Updates

• Last Update Posted (Actual): November 9, 2018
• Last Update Submitted That Met QC Criteria: November 7, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: HM20008890

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No