Clinical trial NCT02523781: Evaluation of an Information Pamphlet for Postpartum Women That Had a Hypertensive Pregnancy
Official title: Evaluation of an Information Pamphlet to Improve Knowledge Concerning the Impacts and the Importance of Healthy Lifestyle After a Pregnancy With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension, Pregnancy-Induced
Keywords: preeclampsia
information pamphlet
patient education
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2015-08-14
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: knowledge improvement (questionnaire with check list and true/false questions).
timeFrame: 4 weeks
Secondary outcomes:
measure: Perception of cardiovascular risk between the intervention and the control group at one month (Likert scale)
timeFrame: 4 weeks
measure: Anxiety between the intervention and the control group at one month.(Likert scale)
timeFrame: 4 weeks
measure: Satisfaction between the intervention and the control group at one month.(Likert scale)
timeFrame: 4 weeks
measure: Perception of cardiovascular risk in the intervention group between baseline and at one month (Likert scale)
timeFrame: 4 weeks
measure: Perception of cardiovascular risk between baseline and at one month in the control group. (Likert scale)
timeFrame: 4 weeks
measure: Anxiety in the intervention group between baseline and at one month (Likert scale)
timeFrame: 4 weeks
measure: Anxiety in the control group between baseline and at one month (Likert scale)
timeFrame: 4 weeks
measure: Satisfaction in the intervention group between baseline and at one month(Likert scale)
timeFrame: 4 weeks
measure: Satisfaction in the control group between baseline and at one month (Likert scale)
timeFrame: 4 weeks
measure: Knowledge in the intervention group between baseline and at one month (questionnaire with check list and true/false questions).
timeFrame: 4 weeks
measure: Knowledge in the control group between baseline and at one month (questionnaire with check list and true/false questions).
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre Hopitalier Universiatire de Sherbrooke
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Sauvé Nadine, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Sherbrooke
name: Anne-Marie côté, MD
role: STUDY_CHAIR
affiliation: Université de Sherbrooke
name: Annabelle Cumyn, MD
role: STUDY_CHAIR
affiliation: Université de Sherbrooke
name: Marie-Eve Roy-Lacroix, MD
role: STUDY_CHAIR
affiliation: Université de Sherbrooke
name: Myriam Champagne, MD
role: STUDY_CHAIR
affiliation: Université de Sherbrooke
name: Marie-Hélène Pesant, MD
role: STUDY_CHAIR
References: