NCT02746601

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 21, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 26, 2020

Status Verified

May 1, 2020

Enrollment Period

1.3 years

First QC Date

April 10, 2016

Last Update Submit

May 21, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • Patient-reported risk factors as assessed by Risk Assessment Tool

    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

    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

    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

Study Arms (1)

Risk Assessment, Counselling & Resources

EXPERIMENTAL

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

Interventions

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.

Risk Assessment, Counselling & Resources

Eligibility Criteria

Age15 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Minto-Mapleton Family Health Team

Drayton, Ontario, N0G1P0, Canada

Location

East Wellington Family Health Team

Erin, Ontario, N0B1T0, Canada

Location

Upper Grand Family Health Team

Fergus, Ontario, N1M2R2, Canada

Location

Norfolk Family Medical

Guelph, Ontario, N1H4J4, Canada

Location

University of Guelph

Guelph, Ontario, Canada

Location

MeSH Terms

Interventions

Risk AssessmentCounselingHealth Resources

Intervention Hierarchy (Ancestors)

RiskProbabilityStatistics as TopicEpidemiologic MethodsInvestigative TechniquesRisk ManagementOrganization and AdministrationHealth Services AdministrationHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public HealthMental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth PlanningHealth Care Economics and OrganizationsDelivery of Health Care

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2016

First Posted

April 21, 2016

Study Start

February 1, 2016

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

May 26, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will share

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

Locations