Preconception CareNCT02746601
My Health eSnapshot - A Preconception Health Research Study
A study testing Risk Assessment, Counselling & Resources in people with Preconception Care and Health Information Technology, run by Wellington-Dufferin-Guelph Public Health at 5 sites in Canada.
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… Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preconception Care, Health Information Technology, Primary Health Care
- What is being tested?
- Risk Assessment, Counselling & Resources
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 5 sitesCanada
- Study dates
- Feb 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Minto-Mapleton Family Health Team
Drayton, Ontario, N0G1P0
East Wellington Family Health Team
Erin, Ontario, N0B1T0
Upper Grand Family Health Team
Fergus, Ontario, N1M2R2
Norfolk Family Medical
Guelph, Ontario, N1H4J4
University of Guelph
Guelph, Ontario
About this 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).
Read the 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.
- Being tested
- Risk Assessment, Counselling & Resources
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk Assessment, Counselling & ResourcesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Risk Assessment, Counselling & Resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startFeb 2016
- Primary completionJun 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preconception CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wellington-Dufferin-Guelph Public Health
- Sponsor type
- Other government
- Collaborators
- University of Guelph, Boston Medical Center, East Wellington Family Health Team, Minto-Mapleton Family Health Team, Upper Grand Family Health Team, Norfolk Family Medical
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02746601
- Sponsor's protocol ID
- 2016-1
- Status last verified
- May 2020
- First submitted
- 10 Apr 2016
- Last updated
- 26 May 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Non-identifying, client level data will be shared with Boston Medical Centre via encrypted means.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- My Health eSnapshot - A Preconception Health Research Study
- ClinicalTrials.gov ID
- NCT02746601
- Acronym / sponsor ID
- 2016-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Wellington-Dufferin-Guelph Public HealthOther government
- Collaborators
- University of Guelph, Boston Medical Center, East Wellington Family Health Team, Minto-Mapleton Family Health Team, Upper Grand Family Health Team, Norfolk Family Medical
- Study start
- Feb 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 21 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Risk Assessment, Counselling & Resources | Experimental | Behavioral: Risk Assessment, Counselling & ResourcesPatients 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. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk Assessment, Counselling & ResourcesA 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. | Behavioural | Risk Assessment, Counselling & Resources |
Primary outcome
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
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2020.
- Individual participant dataSharing planned: Yes. Non-identifying, client level data will be shared with Boston Medical Centre via encrypted means.
Related trials for Preconception Care
Active, not recruiting
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Overweight and Obesity, Pregnancy Complications
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Promoting Preconception Care and Diabetes Self-Management Among Reproductive-Aged Women With Diabetes
Diabetes Mellitus, Type 2, Electronic Health Record
Active, not recruiting
Group Preconception Care for Fertility Patients
Infertility
Recruiting
Improving Alcohol and Substance Use Care Access, Outcome, Equity During the Reproductive Years
Alcohol-Related Disorders, Substance-Related Disorders
Not yet recruiting
Lifestyle, Education, Activity, Nutrition (LEAN) Into Pregnancy
Pregnancy, Preconception Education
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risk Assessment, Counselling & Resources in people with Preconception Care and Health Information Technology, run by Wellington-Dufferin-Guelph Public Health at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported risk factors as assessed by Risk Assessment Tool (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2020.