NCT01529918

Brief Summary

This pilot RCT study aims to develop and evaluate the uptake, feasibility, and potential value of a strategy for web-diabetes risk assessment versus paper-based methods in an undiagnosed diabetes population over 40 years of age from all listed FHT provided through an electronic medical record database. Following randomization, intervention participants will have the option to decide to use web-based self-screening and the control group will receive only a paper-based method. There will be two options for web-based screening; one involves completion of the CAN-RISK screening tool as part of a personal health record self-management program (MyOscar) versus a one off online risk-assessment. The intervention and control group will be compared with respect to risk-assessment uptake. Educational sessions and further assessment of diabetes conducted by the clinical health care team will be offered to all participants who scored a high risk of diabetes in accordance with the CAN-RISK results. Actual numbers of diabetes cases in those with a high risk score will be compared between the intervention and control groups as well as compared to the usual method of diabetes screening in a randomly chosen non-identifiable sample from the same clinical setting in the same one year period. The assessment of patient acceptability in feasibility of the implementation of the self-screening tool will be accomplished through surveys designed to be completed by patients and staff.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for not_applicable diabetes

Timeline
Completed

Started Nov 2009

Typical duration for not_applicable diabetes

Status
unknown

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

November 1, 2009

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 9, 2012

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

February 9, 2012

Status Verified

October 1, 2009

Enrollment Period

2.3 years

First QC Date

February 7, 2012

Last Update Submit

February 8, 2012

Conditions

Keywords

DiabetesSelf-screeningWeb-based technologyfollow-up clinical carerandomized control trial

Outcome Measures

Primary Outcomes (1)

  • Patient's uptake and preferences

    Numbers of patients participating in the self risk-assessment, and a comparison of paper versus web-based technologies will be collected. * Demographics of the 2 groups will be compared. * A user-satisfaction survey will assess patients' perceptions of the technologies. Use of necessary qualitative techniques can be considered as well.

    1 year

Secondary Outcomes (1)

  • The comparison of yield of actual diabetes detected from those who have high risk at self risk-assessment, compared to the usual diabetes detection rate in a random sample from the practice within a one year period.

    1 year

Study Arms (2)

web-intervention group

EXPERIMENTAL

Participants will receive access to the CAN-RISK (Canadian Diabetes Risk Assessment) questionnaire either via personal patient electronic health record or an online version

Other: CANRISK (Canadian Diabetes Association Assessment)

paper-based group

NO INTERVENTION

Participants allocated to paper-based will receive the CAN-RISK questionnaire for diabetes risk-assessment via paper-based

Other: CANRISK (Canadian Diabetes Association Assessment)

Interventions

Self-risk assessment questionnaire for diabetes

paper-based groupweb-intervention group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 40 and over who did not have diagnosis of diabetes and no previous use of personal health record (MyOscar)

You may not qualify if:

  • People with diabetes, and those who are already registered as MyOSCAR (personal e-health record) users

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Gina Agarwal, Dr.

    McMaster University, Department of Family Medicine

    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

February 7, 2012

First Posted

February 9, 2012

Study Start

November 1, 2009

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

February 9, 2012

Record last verified: 2009-10