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Diabetes Engagement and Activation Platform (DEAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02957721
Recruitment Status : Completed
First Posted : November 8, 2016
Last Update Posted : November 9, 2018
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief Summary:

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes (T2D) Other: Usual Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: DEAP: Diabetes Engagement and Activation Platform
Actual Study Start Date : November 1, 2017
Actual Primary Completion Date : November 5, 2018
Actual Study Completion Date : November 5, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Change in A1C [ 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. ]
    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 :
  1. Patient Activation Measure (PAM 10) [ 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. ]
    measures how well patients self-manage diabetes.

  2. Body Mass Index (BMI) [ 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 ]
    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.

  3. Blood Pressure (BP) [ 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. ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02957721


Locations
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United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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Principal Investigator: Alexander H Krist, MD Virginia Commonwealth University

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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT02957721    
Other Study ID Numbers: HM20008890
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases