My Health eSnapshot - A Preconception Health Research Study

• Sponsor: Wellington-Dufferin-Guelph Public Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT02746601
• Collaborator: University of Guelph (Other), Boston Medical Center (Other), East Wellington Family Health Team (Other), Minto-Mapleton Family Health Team (Other), Upper Grand Family Health Team (Other), Norfolk Family Medical (Other)
• Enrollment: 300
• Locations: 5
• Arm: 1
• Actual Duration (Months): 22
• Patients Per Site: 60
• Patients Per Site Per Month: 2.7

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 300 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: My Health eSnapshot - A Preconception Health Research Study
• Actual Study Start Date: Feb 1, 2016
• Actual Primary Completion Date: Jun 1, 2017
• Actual Study Completion Date: Dec 1, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Patient-reported risk factors as assessed by Risk Assessment Tool [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 49 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Minto-Mapleton Family Health Team	Drayton	Ontario	Canada	N0G1P0
2	East Wellington Family Health Team	Erin	Ontario	Canada	N0B1T0
3	Upper Grand Family Health Team	Fergus	Ontario	Canada	N1M2R2
4	Norfolk Family Medical	Guelph	Ontario	Canada	N1H4J4
5	University of Guelph	Guelph	Ontario	Canada

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wellington-Dufferin-Guelph Public Health
• ClinicalTrials.gov Identifier: NCT02746601
• Other Study ID Numbers: 2016-1
• First Posted: Apr 21, 2016
• Last Update Posted: May 26, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes

Study Results

No Results Posted as of May 26, 2020