Evaluation of Educational Tools for Pregnant Women

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2013 by Université de Sherbrooke
Sponsor:
Information provided by (Responsible Party):
Nadine Sauvé, Universitaire de Sherbrooke
ClinicalTrials.gov Identifier:
NCT01858324
First received: May 14, 2013
Last updated: May 16, 2013
Last verified: May 2013
  Purpose

Hypertensive disorders of pregnancy happen in 5% of pregnancies. Being aware of symptoms and complications may help women to present early and preserve their own and their baby's health.

The proposed research aims to evaluate the impact of educational tools in pregnant women from an ambulatory population. These tools include a detailed pamphlet (including a graphic-based summary), a magnet summarizing symptoms and appropriate action, and a video. Level of knowledge will be evaluated after one month with a validated questionnaire. We will also evaluate if getting more information about preeclampsia increases patient anxiety as well as satisfaction about the tools.


Condition Intervention
Preeclampsia
Other: Educational tools

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of Educational Tools Concerning Hypertension in Ambulatory Pregnant Women, Compared With Usual Antenatal Care

Resource links provided by NLM:


Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • Knowledge about preeclampsia [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Through a questionnaire (7 questions, 35 statements, one global score)


Secondary Outcome Measures:
  • Anxiety [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    Question 1: 8 statements (Likert's scale 1 to 6) Question 2 more general

  • Satisfaction [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    3 questions


Other Outcome Measures:
  • Sub-group analysis: age [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Diferences in outcomes between control and intervention groups according to group age

  • Sub-group analysis: parity [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Differences between control and intervention group according to parity.

  • Sub-group analysis: pre-pregnancy BMI [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Differences between control and intervention group according to pre-pregnancy BMI

  • Sub-group analysis: category of health care provider [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Differences between control and intervention group according to category of healthcare provider

  • Sub-group analysis: preeclampsia risk factors [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Differences between control and intervention group according to preeclampsia risk factors (pre-pregnancy diseases or a history of preeclampsia

  • Sub-group analysis: tobacco use [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Differences between control and intervention group according to tobacco use

  • Sub-group analysis: [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Differences between control and intervention group according to employment type

  • Sub-group analysis: ethnicity [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Differences between control and intervention group according to ethnicity

  • Sub-group analysis: socio-economic level [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Differences between control and intervention group according to socio-economic level

  • Sub-group analysis: educational level [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Differences between control and intervention group according to educational level

  • Sub-group analysis: marital status [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Differences between control and intervention group according to marital status

  • Sub-group analysis:video viewed on site vs. at home [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Differences between control and intervention group according to video viewed on-site vs. at home

  • Sub-group analysis:delay since last consultation of the tools [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Differences between control and intervention group according to delay since last consultation of the tools.


Estimated Enrollment: 400
Study Start Date: September 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: educational tools
Subjects will receive at time 0 the educational tools (pamphlet-including a graphic-based summary, a magnet and a 12 minutes video). They will then have to answer a questionnaire 1 month later about knowledge, anxiety and satisfaction.
Other: Educational tools
Subjects will receive the educational tools. They will then receive one month after a questionnaire about knowledge, anxiety and satisfaction.
Other Names:
  • Pamphlet (including a graphic-based summary)
  • Magnet-summary
  • Video
No Intervention: Usual antenatal care
Subjects in this group will not receive any more educational tools that what is generally offered in routine antenatal care.

Detailed Description:

Background: Preeclampsia is a leading cause of maternal/fetal morbidity/mortality. Pregnant women are often poorly informed on preeclampsia and seeking care too late results in maternal/fetal complications. Many healthcare providers believe that delivering information for low-risk women only make them more anxious.

Preliminary data: We published that an information pamphlet on preeclampsia increases knowledge, without increasing anxiety, and generates high satisfaction in women hospitalized for preeclampsia.

Objectives: Demonstrate that (1) ambulatory low-risk pregnant women will benefit from the pamphlet/video with improved knowledge; (2) without any increase in anxiety, and with great satisfaction.

Design: Prospective randomized controlled pilot study. Inclusion criteria: consecutive pregnant women aged ≥18 y.o. between 200-326 weeks presenting at the clinic and who read/write French or English. Exclusion criteria: Anticipated delivery or termination within one month. Intervention: pamphlet, magnet and video. Control: no educational tool. At baseline, women in both groups will answer questionnaire #1 on demographics; one month later: self-administered questionnaire #2 on knowledge, anxiety, satisfaction.

Sample size: N=178 will provide 80% power to find a significant improvement of at least 20% in knowledge score and 96% power to find a difference of at least 1 on scale for anxiety (alpha of 5%). Assuming a drop-out rate of 10%, missing answers <20%, and rate of answered questionnaire #2 of 50%, 400 subjects will be recruited.

Anticipated results: The tools will improve knowledge by about 20% in intervention group compared to control group. They will not increase anxiety over one point and will be highly appreciated by women.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women between 20+0 to 32+6 weeks pregnant
  • Aged 18 years old or more
  • Who present at the Blood Sampling in Pregnancy clinic
  • With an adequate understanding of written and spoken French or English in order to read the pamphlet and fill out the self-administered questionnaire

Exclusion Criteria:

  • Consideration of an interruption of pregnancy for maternal or fetal reasons
  • Anticipated delivery within the next month.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01858324

Contacts
Contact: Nadine Sauve, MD 819-346-1110 ext 74977 nadine.sauve@usherbrooke.ca
Contact: Julie Moreau, MSc 819-346-1110 ext 16213 jmoreau.chus@ssss.gouv.qc.ca

Locations
Canada, Quebec
Centre Hopitalier Universiatire de Sherbrooke Not yet recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Principal Investigator: Nadine Sauve, MD         
Sponsors and Collaborators
Université de Sherbrooke
Investigators
Principal Investigator: Nadine Sauve, MD Centre de recherche clinique of the Centre Hopitalier Universitaire de Sherbrooke
  More Information

No publications provided

Responsible Party: Nadine Sauvé, Member of the Mother & Child Research Axis of the clinical research center Etienne Le Bel, Universitaire de Sherbrooke
ClinicalTrials.gov Identifier: NCT01858324     History of Changes
Other Study ID Numbers: 13-025
Study First Received: May 14, 2013
Last Updated: May 16, 2013
Health Authority: Canada: Ethics Review Committee
Canada: Ministère santé et services sociaux du Québec

Keywords provided by Université de Sherbrooke:
Preeclampsia
Hypertensive disorders of pregnancy
Patient education
Educationnal tools
Pamphlet
Video
Knowledge
Anxiety
Satisfaction

Additional relevant MeSH terms:
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications

ClinicalTrials.gov processed this record on September 16, 2014