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My Health eSnapshot - A Preconception Health Research Study

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ClinicalTrials.gov Identifier: NCT02746601
Recruitment Status : Unknown
Verified November 2016 by Wellington-Dufferin-Guelph Public Health.
Recruitment status was:  Recruiting
First Posted : April 21, 2016
Last Update Posted : November 11, 2016
Sponsor:
Collaborators:
University of Guelph
Boston Medical Center
East Wellington Family Health Team
Minto-Mapleton Family Health Team
Upper Grand Family Health Team
Norfolk Family Medical
Information provided by (Responsible Party):
Wellington-Dufferin-Guelph Public Health

Brief Summary:
The purpose of the research is to identify the prevalence of preconception health (PCH) risk factors in the Wellington-Dufferin-Guelph (WDG) catchment area and to determine whether or not a client-driven electronic preconception health risk assessment tool "My Health eSnapshot", for use during healthcare visits, will increase preconception health knowledge and behaviour change among women of reproductive age (15-49 years).

Condition or disease Intervention/treatment Phase
Preconception Care Health Information Technology Primary Health Care Risk Assessment Behavioral: Risk Assessment, Counselling & Resources Not Applicable

Detailed Description:

The purpose of the project is:

  1. To develop a client-driven electronic preconception health client risk assessment tool for use in a primary care setting.
  2. To develop a customized key message handout for patients based on their risk assessment results.
  3. To determine a successful and sustainable process for healthcare providers (HCPs) to administer the risk assessment tool and discuss results with patients within their primary care setting.
  4. To increase participants' knowledge of preconception health and their risk factors as a results of the risk assessment tool and discussion with their HCP.
  5. To modify participants' health behaviours as a result of the risk assessment tool and discussion with their HCP.
  6. To increase WDG Public Health's understanding of the most prevalent preconception health risk factors among reproductive women in WDG.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 720 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: My Health eSnapshot - A Preconception Health Research Study
Study Start Date : February 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Experimental: Risk Assessment, Counselling & Resources
Patients complete an electronic preconception health risk assessment tool. Results from the tool are directly uploaded or scanned into the patients' electronic medical record. A healthcare provider provides behavioural counselling, based on results of the risk assessment. Patients are given a customized handout that includes health recommendations and resources based on the patient's identified risk factors.
Behavioral: Risk Assessment, Counselling & Resources
A risk assessment tool is completed on a tablet. The results are scanned into the patient's electronic medical record. A healthcare provider gives behavioural counselling on identified risk factors. The patient is given a customized handout that includes health recommendations and resources based on the participant's identified risk factors.




Primary Outcome Measures :
  1. Patient-reported risk factors as assessed by Risk Assessment Tool [ Time Frame: Baseline ]
    Patient completes a risk assessment tool in their healthcare provider's office on a tablet, prior to an appointment with their Health Care Provider

  2. Patient-reported feedback on Risk Assessment, Counselling, and Resources as assessed by a One-Week Survey [ Time Frame: One week ]
    The patient will complete an online survey tool in their home one week after completing the risk assessment tool. The survey asks questions about their experience competing the risk assessment tool, talking with their health care provider, and receiving their customized patient handout. The patient will also provide feedback on the strengths and limitations of the risk assessment tool and patient handout. This feedback will contribute to future modifications to study tools and processes.

  3. Patient-reported health behaviour change and motivation for health behaviour change as assessed by a two-month survey [ Time Frame: Two months ]
    Patient complete an online survey tool in their home two months after completing the risk assessment tool. The survey asks questions about whether there has been any changes in motivation regarding changing health behaviours and whether any changes have actually been made to the health behaviours.



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Ages Eligible for Study:   15 Years to 49 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women of reproductive age (15-49 years)
  • Not pregnant and have not had a hysterectomy
  • A resident of the Wellington-Dufferin-Guelph catchment area
  • Able to read and write in English
  • Have a valid email address
  • Willing to create a unique identifier code during the study to protect their identify
  • Are comfortable using a tablet

Exclusion Criteria:


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 ClinicalTrials.gov identifier (NCT number): NCT02746601


Contacts
Contact: Liz Robson, MPH 1-800-265-7293 ext 4218 liz.robson@wdgpublichealth.ca
Contact: Andrea Roberts, BA 1-800-265-7293 ext 4335 andrea.roberts@wdgpublichealth.ca

Locations
Canada, Ontario
Minto-Mapleton Family Health Team Recruiting
Drayton, Ontario, Canada, N0G1P0
Contact: Shirley Borges    519-638-2110 ext 227    sborges@mmfht.ca   
East Wellington Family Health Team Recruiting
Erin, Ontario, Canada, N0B1T0
Contact: Michelle Karker    519-833-7576 ext 350    michelle.karker@ewfht.ca   
Upper Grand Family Health Team Recruiting
Fergus, Ontario, Canada, N1M2R2
Contact: Lana Palmer    519-843-3947 ext 101    lana.palmer@uppergrandfht.org   
Norfolk Family Medical Recruiting
Guelph, Ontario, Canada, N1H4J4
Contact: Katherine Miller, MD    519-836-9440    drkjmiller@yahoo.ca   
University of Guelph Not yet recruiting
Guelph, Ontario, Canada
Contact: Alison Burnett    519-822-4120 ext 54333    burnetta@uoguelph.ca   
Sponsors and Collaborators
Wellington-Dufferin-Guelph Public Health
University of Guelph
Boston Medical Center
East Wellington Family Health Team
Minto-Mapleton Family Health Team
Upper Grand Family Health Team
Norfolk Family Medical

Responsible Party: Wellington-Dufferin-Guelph Public Health
ClinicalTrials.gov Identifier: NCT02746601     History of Changes
Other Study ID Numbers: 2016-1
First Posted: April 21, 2016    Key Record Dates
Last Update Posted: November 11, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Non-identifying, client level data will be shared with Boston Medical Centre via encrypted means.