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

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
McMaster University

Tracking Information
First Submitted Date  ICMJE February 7, 2012
First Posted Date  ICMJE February 9, 2012
Last Update Posted Date February 9, 2012
Study Start Date  ICMJE November 2009
Estimated Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2012)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Detecting Diabetes Sooner With a Risk Survey for the Family Doctor:Comparing Internet and Traditional Methods of Communication for Patients and Doctors
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Diabetes
Intervention  ICMJE Other: CANRISK (Canadian Diabetes Association Assessment)
Self-risk assessment questionnaire for diabetes
Study Arms  ICMJE
  • 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
    Intervention: Other: CANRISK (Canadian Diabetes Association Assessment)
  • No Intervention: paper-based group
    Participants allocated to paper-based will receive the CAN-RISK questionnaire for diabetes risk-assessment via paper-based
    Intervention: Other: CANRISK (Canadian Diabetes Association Assessment)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 8, 2012)
2000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2012
Estimated Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01529918
Other Study ID Numbers  ICMJE eDM-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party McMaster University
Study Sponsor  ICMJE McMaster University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gina Agarwal, Dr. McMaster University, Department of Family Medicine
PRS Account McMaster University
Verification Date October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP