- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02746601
My Health eSnapshot - A Preconception Health Research Study
May 21, 2020 updated by: Wellington-Dufferin-Guelph Public Health
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
Status
Completed
Intervention / Treatment
Detailed Description
The purpose of the project is:
- To develop a client-driven electronic preconception health client risk assessment tool for use in a primary care setting.
- To develop a customized key message handout for patients based on their risk assessment results.
- 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.
- To increase participants' knowledge of preconception health and their risk factors as a results of the risk assessment tool and discussion with their HCP.
- To modify participants' health behaviours as a result of the risk assessment tool and discussion with their HCP.
- 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.
Clinical Trials on Primary Health Care
-
Veteran Affairs Office of Patient Care ServicesVA Office of Research and Development; VA Palo Alto Health Care System; VHA Primary...CompletedPrimary Health Care | Health Care CostsUnited States
-
Veteran Affairs Office of Patient Care ServicesVA Office of Research and Development; VA Palo Alto Health Care System; VHA Primary...CompletedPrimary Health Care | Health Care Costs
-
VA Office of Research and DevelopmentVA Palo Alto Health Care System; Veteran Affairs Office of Patient Care ServicesCompletedPrimary Health Care | Health Care Costs
-
University of CoimbraCompletedPalliative Care | Primary Health CarePortugal
-
Bert LeysenIntermutualistic Agency; National Institute for Health and Disability Insurance...CompletedPalliative Care | Primary Health CareBelgium
-
University of Colorado, DenverCompletedPrimary Health Care | Advance Care PlanningUnited States
-
University of Beira InteriorWithdrawnPalliative Care | Primary Health Care | GeriatricsPortugal
-
The University of Hong KongNot yet recruitingPrimary Health CareHong Kong
-
Université de SherbrookeIsabelle Gaboury; Mike Green; Tara Kiran; Janusz Kaczorowski; Maude LabergeRecruiting
-
The University of Hong KongCompleted
Clinical Trials on Risk Assessment, Counselling & Resources
-
University of IbadanUniversity College Hospital, Ibadan; Obafemi Awolowo University Teaching Hospital and other collaboratorsCompletedBreast Cancer | Health Behavior | Health Knowledge, Attitudes, Practice | Health Care Utilization | Risk Reduction BehaviorNigeria
-
Nepal Mediciti HospitalCompleted
-
Chinese University of Hong KongCompleted
-
University Health Network, TorontoCanadian Institutes of Health Research (CIHR)CompletedColon Cancer | Colonic NeoplasmsCanada
-
The University of Hong KongActive, not recruiting
-
Bukret Plastic SurgeryCompletedRisk Factors | Risk AssessmentArgentina
-
Magdi Yacoub Heart FoundationRecruiting
-
Instituto Mexicano del Seguro SocialInstituto Nacional de Salud Publica, Mexico; Centro de Investigación en Matemáticas...Completed
-
Oslo Metropolitan UniversityNorwegian Labour and Welfare AdministrationActive, not recruitingMusculoskeletal Pain DisorderNorway
-
National Institute on Aging (NIA)Wishard Health Services; Nina Mason Pulliam Charitable TrustCompletedAging | Functional DeclineUnited States