NCT01440530

Brief Summary

The purpose of this 3 site, 24-week, Comparative Effectiveness Randomized Clinical Trial in Primary Care is to compare usual care to an online, multi-media, digital intervention for Persons with Type 2 Diabetes to Improve Engagement, Knowledge, and Self-Care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
170

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Feb 2010

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

3 active sites

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

Study Start

First participant enrolled

February 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 26, 2011

Completed
Last Updated

September 26, 2011

Status Verified

September 1, 2011

Enrollment Period

9 months

First QC Date

September 20, 2011

Last Update Submit

September 23, 2011

Conditions

Keywords

Diabetes Internet EducationDiabetes EducationDiabetes Self-CareDiabetes Self-ManagementDiabetes Behavior Intervention

Outcome Measures

Primary Outcomes (1)

  • Diabetes Knowledge

    Change from Baseline Total Score on Diabetes Knowledge Questionnaire(DKQ)at 6 months.The DKQ is the shortened 24-item version of the Diabetes Knowledge Questionnaire was derived from an original 60-item instrument to reduce participant burden.Scores on the 60-item and 24-item versions are well correlated (r=0.85).Collins,G.S.,et al.,Modification and validation of the Revised Diabetes Knowledge Scale. Diabet Med, 2011. 28(3):p.306-10. Fitzgerald,J.T.,et al.,The reliability and validity of a brief diabetes knowledge test.Diabetes Care,1998.21(5):p.706-10.

    6 months

Secondary Outcomes (1)

  • Diabetes Self Care

    6 months

Study Arms (2)

Educational Intervention

EXPERIMENTAL
Behavioral: Educational Intervention

Control Group (usual care)

ACTIVE COMPARATOR
Other: Usual Care

Interventions

Following randomization to TIDES (N=117) or usual care (N=49), TIDES group was oriented to the multimedia online intervention including a dosed sequence of learning via email, video, slideshows, food solutions, expert questions and answers, and quizzes.

Educational Intervention

Following randomization to TIDES (N=117) or usual care (N=49), TIDES group was oriented to the multimedia online intervention including a dosed sequence of learning via email, video, slideshows, food solutions, expert questions and answers, and quizzes.

Control Group (usual care)

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diabetes Mellitus Type 2
  • Geisinger Primary Care Provider
  • Access to a computer

You may not qualify if:

  • Severe medical problems that limits travel to primary care
  • Diabetes Type 1
  • Cognitive Impairment
  • Taking anti-psychotic meds

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Geisinger Clinic - Gray's Woods

Port Matilda, Pennsylvania, 16870, United States

Location

Geisinger Clinic - Kistler

Wilkes-Barre, Pennsylvania, 18702, United States

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Margaret R Rukstalis, MD

    Geisinger Clinic

    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

September 20, 2011

First Posted

September 26, 2011

Study Start

February 1, 2010

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

September 26, 2011

Record last verified: 2011-09

Locations