Working… Menu

Detecting Diabetes Sooner With a Risk Survey for the Family Doctor:Comparing Internet and Traditional Methods of Communication for Patients and Doctors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01529918
Recruitment Status : Unknown
Verified October 2009 by McMaster University.
Recruitment status was:  Active, not recruiting
First Posted : February 9, 2012
Last Update Posted : February 9, 2012
Information provided by (Responsible Party):
McMaster University

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.

Condition or disease Intervention/treatment Phase
Diabetes Other: CANRISK (Canadian Diabetes Association Assessment) Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: e-Diabetes:Uptake, Patient Preferences and Clinical Outcomes Regarding Self-screening and Clinical Follow-up Using Web-based Technologies in a Large Team-based Primary Care Setting
Study Start Date : November 2009
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Experimental: web-intervention group
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)
Self-risk assessment questionnaire for diabetes

No Intervention: paper-based group
Participants allocated to paper-based will receive the CAN-RISK questionnaire for diabetes risk-assessment via paper-based
Other: CANRISK (Canadian Diabetes Association Assessment)
Self-risk assessment questionnaire for diabetes

Primary Outcome Measures :
  1. Patient's uptake and preferences [ Time Frame: 1 year ]

    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.

Secondary Outcome Measures :
  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. [ Time Frame: 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01529918

Sponsors and Collaborators
McMaster University
Layout table for investigator information
Principal Investigator: Gina Agarwal, Dr. McMaster University, Department of Family Medicine

Layout table for additonal information
Responsible Party: McMaster University Identifier: NCT01529918     History of Changes
Other Study ID Numbers: eDM-1
First Posted: February 9, 2012    Key Record Dates
Last Update Posted: February 9, 2012
Last Verified: October 2009
Keywords provided by McMaster University:
Web-based technology
follow-up clinical care
randomized control trial
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases