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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02523781
Enrollment
90
Registered
2015-08-14
Start date
2015-06-30
Completion date
2020-07-31
Last updated
2021-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Pregnancy-Induced

Keywords

preeclampsia, information pamphlet, patient education

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.

Interventions

The intervention group receives the information pamphlet

Sponsors

Université de Sherbrooke
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
knowledge improvement (questionnaire with check list and true/false questions).4 weeksThe 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).

Secondary

MeasureTime frameDescription
Anxiety between the intervention and the control group at one month.(Likert scale)4 weeksComparison 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)4 weeksComparison 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)4 weeksThe 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)4 weeksThe 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)4 weeksThe comparison of anxiety between baseline and at one month in the intervention group with a validated Likert scale included in the questionnaire.
Perception of cardiovascular risk between the intervention and the control group at one month (Likert scale)4 weeksThe 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.
Satisfaction in the intervention group between baseline and at one month(Likert scale)4 weeksThe 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)4 weeksThe 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).4 weeksThe 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).4 weeksThe comparison of Baseline knowledge and knowledge at one month in the control group with a validated questionnaire (knowledge: check list and true/false questions).
Anxiety in the control group between baseline and at one month (Likert scale)4 weeksThe comparison of anxiety between baseline and at one month in the control group with a validated Likert scale included in the questionnaire

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026