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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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.

Sponsor: Université de Sherbrooke

Current Primary Outcome: knowledge improvement (questionnaire with check list and true/false questions). [ Time Frame: 4 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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
• 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.
• 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.
• 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).
• 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).

Original Secondary Outcome: Same as current

Information By: Université de Sherbrooke

Dates:
Date Received: July 30, 2015
Date Started: June 2015
Date Completion: December 2017
Last Updated: December 6, 2016
Last Verified: December 2016