NCT02082704

Brief Summary

Investigators are conducting a randomized controlled trial to determine whether an online team-based spaced education (SE) game can improve HbA1c levels among these patients with diabetes (primary aim). Secondary aims include determining the impact of the game on patients' pill possession ratio (PPR) of oral DM meds and their microalbumin/creatinine (M/C) ratio, ACE PPR, and ARB PPR.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
456

participants targeted

Target at P75+ for not_applicable diabetes

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

July 12, 2017

Status Verified

July 1, 2017

Enrollment Period

1.2 years

First QC Date

March 4, 2014

Last Update Submit

July 11, 2017

Conditions

Diabetes

Keywords

DiabetesEducation, PatientEducational Technology

Outcome Measures

Primary Outcomes (1)

  • HbA1c levels

    Months 1-12

Secondary Outcomes (16)

  • Microalbumenuria levels [microalbumin-creatinine ratio].

    Months 1-12

  • Pill possession ratios of oral diabetes medications.

    Months 1-12

  • Treatment with angiotensin receptor blockers (ARB drugs) and angiotensin converting enzyme inhibitors (ACE inhibitors).

    Months 1-12

  • Pill possession ratios of angiotensin receptor blockers (ARB drugs) and angiotensin converting enzyme inhibitors (ACE inhibitors).

    Months 1-12

  • Weight / BMI

    Months 1-12

  • +11 more secondary outcomes

Study Arms (2)

SE Game on DSME

EXPERIMENTAL

The intervention cohort will participate in an online team-based game on diabetes self-management education (DSME) and will receive a paper documents on American history,

Behavioral: SE Game on DSME

SE Game on American History

ACTIVE COMPARATOR

The 'attention control' cohort will participate in an online team-based game on American history and will receive a paper documents on DSME.

Behavioral: SE Game on American History

Interventions

SE Game on DSMEBEHAVIORAL

Investigators created an online educational game by incorporating game mechanics into an evidence-based form of online education, termed 'spaced education' (SE). Based upon two psychology research findings (the spacing and testing effects), SE has been shown in randomized trials to improves knowledge acquisition, boosts learning retention for up to two years, and durably improves clinical behavior.

SE Game on DSME
SE Game on American HistoryBEHAVIORAL

Investigators created an online educational game by incorporating game mechanics into an evidence-based form of online education, termed 'spaced education' (SE). Based upon two psychology research findings (the spacing and testing effects), SE has been shown in randomized trials to improves knowledge acquisition, boosts learning retention for up to two years, and durably improves clinical behavior.

SE Game on American History

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients in the northeastern Veterans Affairs hospital system who are taking oral diabetes medications, have a PPR\<80%, and have a HbA1c \>7.5.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Veterans Affairs Boston Healthcare System

Boston, Massachusetts, 02130, United States

Location

Related Publications (1)

  • Kerfoot BP, Gagnon DR, McMahon GT, Orlander JD, Kurgansky KE, Conlin PR. A Team-Based Online Game Improves Blood Glucose Control in Veterans With Type 2 Diabetes: A Randomized Controlled Trial. Diabetes Care. 2017 Sep;40(9):1218-1225. doi: 10.2337/dc17-0310. Epub 2017 Aug 8.

    PMID: 28790131DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • B. Price Kerfoot, MD EdM

    VA Boston Healthcare System

    PRINCIPAL INVESTIGATOR

  • Paul R. Conlin, MD

    VA Boston Healthcare System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2014

First Posted

March 10, 2014

Study Start

June 1, 2014

Primary Completion

August 1, 2015

Study Completion

November 1, 2016

Last Updated

July 12, 2017

Record last verified: 2017-07

Locations

US(1)