Diabetes Self-Management & Support LIVE

NCT ID: NCT02040038

Last Updated: 2018-04-06

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

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2018-03-31

Brief Summary

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The purpose of this study is to determine whether participation in virtual environment which incorporates real-time diabetes self management and support (DSMT/S) is associated with positive changes in behavior and metabolic outcomes as compared to traditional web-based DSMT/S.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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LIVE Arm

Participation in 3D virtual environment for DSMT/S for a period of 12 months.

Group Type EXPERIMENTAL

LIVE

Intervention Type BEHAVIORAL

3-D Virtual Environment for DSMT/S

Website

Participation in 2D website for DSMT/S for a period of 12 months.

Group Type ACTIVE_COMPARATOR

Website

Intervention Type BEHAVIORAL

2-D Website participation for DSMT/S

Interventions

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LIVE

3-D Virtual Environment for DSMT/S

Intervention Type BEHAVIORAL

Website

2-D Website participation for DSMT/S

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Live in close proximity to Duke University Medical Center (DUMC) or NYU Endocrinology Clinic, or Faculty Practice and Bellevue Medical Center to facilitate follow-up research appointments
* Diagnosis of Type 2 Diabetes (T2D)
* \>= 21 years old
* able to read and understand English
* access to a computer with broad band internet connection in a private location
* reachable by telephone
* no pre-existing medical condition(s) or severe diabetes related complications that would interfere with study participation (e.g.
* Are able to travel to a clinical lab for blood work

Exclusion Criteria

\-
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Constance M. Johnson, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University School of Nursing

Allison Vorderstrasse, DNSc

Role: PRINCIPAL_INVESTIGATOR

Duke University School of Nursing

Gail Melkus, EdD

Role: PRINCIPAL_INVESTIGATOR

New York University

Locations

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New York University

New York, New York, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

References

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Johnson CM, D'Eramo Melkus G, Reagan L, Pan W, Amarasekara S, Pereira K, Hassell N, Nowlin S, Vorderstrasse A. Learning in a Virtual Environment to Improve Type 2 Diabetes Outcomes: Randomized Controlled Trial. JMIR Form Res. 2023 Apr 20;7:e40359. doi: 10.2196/40359.

Reference Type DERIVED
PMID: 36962700 (View on PubMed)

Johnson CM, McIlwain S, Gray O, Willson B, Vorderstrasse A. Creating a sustainable collaborative consumer health application for chronic disease self-management. J Biomed Inform. 2017 Jul;71:198-206. doi: 10.1016/j.jbi.2017.06.004. Epub 2017 Jun 6.

Reference Type DERIVED
PMID: 28600025 (View on PubMed)

Vorderstrasse AA, Melkus GD, Pan W, Lewinski AA, Johnson CM. Diabetes Learning in Virtual Environments: Testing the Efficacy of Self-Management Training and Support in Virtual Environments (Randomized Controlled Trial Protocol). Nurs Res. 2015 Nov-Dec;64(6):485-93. doi: 10.1097/NNR.0000000000000128.

Reference Type DERIVED
PMID: 26505161 (View on PubMed)

Other Identifiers

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1R01HL118189-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00043325

Identifier Type: -

Identifier Source: org_study_id

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