Evaluation of an Information Pamphlet for Postpartum Women That Had a Hypertensive Pregnancy

April 26, 2021 updated by: Nadine Sauvé, Université de Sherbrooke

Evaluation of an Information Pamphlet to Improve Knowledge Concerning the Impacts and the Importance of Healthy Lifestyle After a Pregnancy With Hypertension

It is known that preeclampsia is a risk factor for cardiovascular diseases, diabetes, chronic hypertension, nephropathy and thromboembolism. The study's aim, subsequent to these informations, is to help prevent those consequences. Information tools have been known to enhance retention of information given orally. The objective of this study is to assess the knowledge and satisfaction of women after an episode of preeclampsia after reading an explanatory pamphlet on preeclampsia. The investigators also want to change their perception on cardiovascular risk, their risk of recurrence and preeclampsia's medium to long-term consequences and the ways to prevent them.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomised-controlled trial. Women recruted will first answer a questionnaire assessing demographic data, knowledge about risks in the future, perception of cardiovascular risk, anxiety about that risk and satisfaction about information received or collected.

Then, women in the intervention group will receive the pamphlet. One month after, women in both groups will receive a questionnaire similar to the first one assessing knowledge about risks in the future, perception of cardiovascular risk, anxiety about that risk and satisfaction about information received or collected, including the pamphlet for the intervention group.

The pamphlet was validated by a multidisciplany team including patients, doctors, nurses, education specialists and communication specialists.

The questionnaire was also validated by the same multidisciplinary team. Section on knowledge and anxiety were remodeled from previously validated questionnaires Section on perception of cardiovascular risk was reproduced and translated with permission from its author.

Section on satisfaction was reproduced from the investigators' previous study where it was validated.

Study Type

Interventional

Enrollment (Actual)

90

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

  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre Hopitalier Universiatire de Sherbrooke

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 18 years and older
  • followed at the CHUS obstetrical clinic for a 4 weeks to 18 months postpartum follow up
  • had hypertension in her last pregnancy

Exclusion criteria:

  • Not able to read and write in French.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
The control group does not receive the information pamphlet
Experimental: Intervention group
The intervention group receives the information pamphlet
Other: information pamphlet
The intervention group receives the information pamphlet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
knowledge improvement (questionnaire with check list and true/false questions).
Time Frame: 4 weeks
The primary outcome will be the comparison of knowledge between the intervention (with the pamphlet) and the control (without the pamphlet) group at one month with a validated questionnaire (knowledge: check list and true/false questions).
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perception of cardiovascular risk between the intervention and the control group at one month (Likert scale)
Time Frame: 4 weeks
The comparison of perception of cardiovascular risk at one month between the intervention (with the pamphlet) and the control (without the pamphlet) group with a validated Likert scale included in the questionnaire.
4 weeks
Anxiety between the intervention and the control group at one month.(Likert scale)
Time Frame: 4 weeks
Comparison of anxiety at one month between the intervention and the control group with a validated Likert scale included in the questionnaire.
4 weeks
Satisfaction between the intervention and the control group at one month.(Likert scale)
Time Frame: 4 weeks
Comparison of satisfaction about all sources of information at one month between the intervention and the control group with a validated Likert scale included in the questionnaire.
4 weeks
Perception of cardiovascular risk in the intervention group between baseline and at one month (Likert scale)
Time Frame: 4 weeks
The comparison of perception of cardiovascular risk between baseline and at one month in the intervention group with a validated Likert scale included in the questionnaire.
4 weeks
Perception of cardiovascular risk between baseline and at one month in the control group. (Likert scale)
Time Frame: 4 weeks
The comparison of perception of cardiovascular risk between baseline and at one month in the control group with a validated Likert scale included in the questionnaire.
4 weeks
Anxiety in the intervention group between baseline and at one month (Likert scale)
Time Frame: 4 weeks
The comparison of anxiety between baseline and at one month in the intervention group with a validated Likert scale included in the questionnaire.
4 weeks
Anxiety in the control group between baseline and at one month (Likert scale)
Time Frame: 4 weeks
The comparison of anxiety between baseline and at one month in the control group with a validated Likert scale included in the questionnaire
4 weeks
Satisfaction in the intervention group between baseline and at one month(Likert scale)
Time Frame: 4 weeks
The comparison of satisfaction between baseline and at one month in the intervention group with a validated Likert scale included in the questionnaire.
4 weeks
Satisfaction in the control group between baseline and at one month (Likert scale)
Time Frame: 4 weeks
The comparison of satisfaction between baseline and at one month in the control group with a validated Likert scale included in the questionnaire.
4 weeks
Knowledge in the intervention group between baseline and at one month (questionnaire with check list and true/false questions).
Time Frame: 4 weeks
The comparison of baseline knowledge and knowledge at one month in the intervention group with a validated questionnaire (knowledge: check list and true/false questions).
4 weeks
Knowledge in the control group between baseline and at one month (questionnaire with check list and true/false questions).
Time Frame: 4 weeks
The comparison of Baseline knowledge and knowledge at one month in the control group with a validated questionnaire (knowledge: check list and true/false questions).
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Sherbrooke

Investigators

  • Principal Investigator: Sauvé Nadine, MD, Université de Sherbrooke
  • Study Chair: Anne-Marie côté, MD, Université de Sherbrooke
  • Study Chair: Annabelle Cumyn, MD, Université de Sherbrooke
  • Study Chair: Marie-Eve Roy-Lacroix, MD, Université de Sherbrooke
  • Study Chair: Myriam Champagne, MD, Université de Sherbrooke
  • Study Chair: Marie-Hélène Pesant, MD, Université de Sherbrooke

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)

June 1, 2015

Primary Completion (Actual)

August 20, 2017

Study Completion (Actual)

July 1, 2020

Study Registration Dates

First Submitted

July 30, 2015

First Submitted That Met QC Criteria

August 13, 2015

First Posted (Estimate)

August 14, 2015

Study Record Updates

Last Update Posted (Actual)

April 27, 2021

Last Update Submitted That Met QC Criteria

April 26, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-1099

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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