NCT00906919

Brief Summary

The goal of this randomized controlled trial is to determine if greater effectiveness can be achieved by the addition of lay-led self-management patient education to regular professionally-led diabetes patient education in comparison to regular professionally-led diabetes patient education only.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
321

participants targeted

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

Timeline
Completed

Started Apr 2004

Longer than P75 for not_applicable diabetes-mellitus-type-2

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2009

Completed
Last Updated

May 21, 2009

Status Verified

May 1, 2009

Enrollment Period

2.9 years

First QC Date

May 19, 2009

Last Update Submit

May 19, 2009

Conditions

Keywords

self-efficacyhealth behaviorpatient educationhealth education

Outcome Measures

Primary Outcomes (1)

  • A1C

    6 months

Secondary Outcomes (4)

  • Self-management behaviors

    6 months

  • Self-efficacy levels

    6 months

  • Health status

    6 months

  • Cholesterol levels

    6 months

Study Arms (2)

Regular diabetes patient education

ACTIVE COMPARATOR

Regular professionally-led diabetes patient education

Behavioral: Regular diabetes patient education

Augmented Diabetes Patient Education

EXPERIMENTAL

Regular professionally-led diabetes patient education augmented by participation in the Stanford Chronic Disease Self-Management Program

Behavioral: Augmented diabetes patient education

Interventions

Professionally-led diabetes patient education delivered by health professionals over a two day period

Regular diabetes patient education

Professionally-led diabetes patient education led by nurse and dietitian over a two day period augmented by participation in the Stanford Chronic Disease Self-Management Program. This program takes place for 2 1/2 hours per week for six consecutive weeks.

Augmented Diabetes Patient Education

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults with type 2 diabetes

You may not qualify if:

  • cognitive impairment
  • unable to speak English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Victoria - Centre on Aging (Ladner Office), Suite 210, 4907 Chisholm Street

Delta, British Columbia, V4K 2K6, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Health BehaviorHealth Education

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehaviorAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and Compliance

Study Officials

  • Patrick T McGowan, PhD

    University of Victoria

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 19, 2009

First Posted

May 21, 2009

Study Start

April 1, 2004

Primary Completion

March 1, 2007

Study Completion

April 1, 2009

Last Updated

May 21, 2009

Record last verified: 2009-05

Locations