My Health eSnapshot - A Preconception Health Research Study

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).

Study Overview

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

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Drayton, Ontario, Canada, N0G1P0
        • Minto-Mapleton Family Health Team
      • Erin, Ontario, Canada, N0B1T0
        • East Wellington Family Health Team
      • Fergus, Ontario, Canada, N1M2R2
        • Upper Grand Family Health Team
      • Guelph, Ontario, Canada
        • University of Guelph
      • Guelph, Ontario, Canada, N1H4J4
        • Norfolk Family Medical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 49 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline
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.
One week
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.
Two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

April 10, 2016

First Submitted That Met QC Criteria

April 20, 2016

First Posted (Estimate)

April 21, 2016

Study Record Updates

Last Update Posted (Actual)

May 26, 2020

Last Update Submitted That Met QC Criteria

May 21, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 2016-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Non-identifying, client level data will be shared with Boston Medical Centre via encrypted means.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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