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

Hypertension, Pregnancy-Induced Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02523781
• Other study ID #: 2016-1099
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: July 2020

Study information

• Verified date: April 2021
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 2020
• Est. primary completion date: August 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pregnancy-Induced

Intervention

Other:
• information pamphlet
The intervention group receives the information pamphlet

Locations

Country	Name	City	State
Canada	Centre Hopitalier Universiatire de Sherbrooke	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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