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

Study Overview
=================
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 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.

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

Conditions
-----------------
Hypertension, Pregnancy-Induced

Intervention / Treatment
-----------------
* Other: information pamphlet


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>The control group does not receive the information pamphlet | |
| Experimental: Intervention group<br>The intervention group receives the information pamphlet | Other: information pamphlet<br>* The intervention group receives the information pamphlet<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| knowledge improvement (questionnaire with check list and true/false questions). | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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). | 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). | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
preeclampsia, information pamphlet, patient education