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Diabetes Engagement and Activation Platform (DEAP)

Primary Purpose

Type 2 Diabetes (T2D)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Usual Care
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes (T2D)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Behavioral self-management

Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Patient Activation Measure (PAM 10)
measures how well patients self-manage diabetes.
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.
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.

Full Information

First Posted
October 28, 2016
Last Updated
November 7, 2018
Sponsor
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT02957721
Brief Title
Diabetes Engagement and Activation Platform
Acronym
DEAP
Official Title
DEAP: Diabetes Engagement and Activation Platform
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
November 5, 2018 (Actual)
Study Completion Date
November 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes (T2D)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
350 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavioral self-management
Arm Type
Other
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Patients will not be given the intervention but receive usual care for T2D.
Primary Outcome Measure Information:
Title
Change in A1C
Description
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.
Time Frame
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 Measure Information:
Title
Patient Activation Measure (PAM 10)
Description
measures how well patients self-manage diabetes.
Time Frame
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.
Title
Body Mass Index (BMI)
Description
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.
Time Frame
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
Title
Blood Pressure (BP)
Description
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.
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander H Krist, MD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33779567
Citation
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.
Results Reference
derived

Learn more about this trial

Diabetes Engagement and Activation Platform

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