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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02746601
Other study ID # 2016-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2016
Est. completion date December 2017

Study information

Verified date May 2020
Source Wellington-Dufferin-Guelph Public Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date December 2017
Est. primary completion date June 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 15 Years to 49 Years
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
Canada Minto-Mapleton Family Health Team Drayton Ontario
Canada East Wellington Family Health Team Erin Ontario
Canada Upper Grand Family Health Team Fergus Ontario
Canada Norfolk Family Medical Guelph Ontario
Canada University of Guelph Guelph Ontario

Sponsors (7)

Lead Sponsor Collaborator
Wellington-Dufferin-Guelph Public Health Boston Medical Center, East Wellington Family Health Team, Minto-Mapleton Family Health Team, Norfolk Family Medical, University of Guelph, Upper Grand Family Health Team

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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