Diabetes Engagement and Activation Platform

NCT ID: NCT02957721

Last Updated: 2018-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2018-11-05

Brief Summary

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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

Detailed Description

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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.

Conditions

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Type 2 Diabetes (T2D)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type OTHER

Usual Care

Intervention Type OTHER

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Usual Care

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexander H Krist, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33779567 (View on PubMed)

Other Identifiers

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HM20008890

Identifier Type: -

Identifier Source: org_study_id

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