Overview

This trial is active, not recruiting.

Condition diabetes
Treatment canrisk (canadian diabetes association assessment)
Sponsor McMaster University
Start date November 2009
End date March 2012
Trial size 2000 participants
Trial identifier NCT01529918, eDM-1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(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
canrisk (canadian diabetes association assessment)
Self-risk assessment questionnaire for diabetes
(No Intervention)
Participants allocated to paper-based will receive the CAN-RISK questionnaire for diabetes risk-assessment via paper-based
canrisk (canadian diabetes association assessment)
Self-risk assessment questionnaire for diabetes

Primary Outcomes

Measure
Patient's uptake and preferences
time frame: 1 year

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 40 years old.

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

Additional Information

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
Principal investigator Gina Agarwal, Dr.
Trial information was received from ClinicalTrials.gov and was last updated in February 2012.
Information provided to ClinicalTrials.gov by McMaster University.