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

Sponsor
Université de Sherbrooke (Other)
Overall Status
Completed
CT.gov ID
NCT02523781
Collaborator
(none)
90
1
2
61
1.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: information pamphlet
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Evaluation of an Information Pamphlet to Improve Knowledge Concerning the Impacts and the Importance of Healthy Lifestyle After a Pregnancy With Hypertension
Actual Study Start Date :
Jun 1, 2015
Actual Primary Completion Date :
Aug 20, 2017
Actual Study Completion Date :
Jul 1, 2020

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control group

The control group does not receive the information pamphlet

Experimental: Intervention group

The intervention group receives the information pamphlet

Other: information pamphlet
The intervention group receives the information pamphlet

Outcome Measures

Primary Outcome Measures

  1. knowledge improvement (questionnaire with check list and true/false questions). [4 weeks]

    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).

Secondary Outcome Measures

  1. Perception of cardiovascular risk between the intervention and the control group at one month (Likert scale) [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.

  2. Anxiety between the intervention and the control group at one month.(Likert scale) [4 weeks]

    Comparison of anxiety at one month between the intervention and the control group with a validated Likert scale included in the questionnaire.

  3. Satisfaction between the intervention and the control group at one month.(Likert scale) [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.

  4. Perception of cardiovascular risk in the intervention group between baseline and at one month (Likert scale) [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.

  5. Perception of cardiovascular risk between baseline and at one month in the control group. (Likert scale) [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.

  6. Anxiety in the intervention group between baseline and at one month (Likert scale) [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.

  7. Anxiety in the control group between baseline and at one month (Likert scale) [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

  8. Satisfaction in the intervention group between baseline and at one month(Likert scale) [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.

  9. Satisfaction in the control group between baseline and at one month (Likert scale) [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.

  10. Knowledge in the intervention group between baseline and at one month (questionnaire with check list and true/false questions). [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).

  11. Knowledge in the control group between baseline and at one month (questionnaire with check list and true/false questions). [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Hopitalier Universiatire de Sherbrooke Sherbrooke Quebec Canada J1H 5N4

Sponsors and Collaborators

  • Université de Sherbrooke

Investigators

  • Principal Investigator: Sauvé Nadine, MD, Université de Sherbrooke
  • Study Chair: Anne-Marie côté, MD, Université de Sherbrooke
  • Study Chair: Annabelle Cumyn, MD, Université de Sherbrooke
  • Study Chair: Marie-Eve Roy-Lacroix, MD, Université de Sherbrooke
  • Study Chair: Myriam Champagne, MD, Université de Sherbrooke
  • Study Chair: Marie-Hélène Pesant, MD, Université de Sherbrooke

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nadine Sauvé, Researcher of the Mother-Child axis of the CRCHUS, Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT02523781
Other Study ID Numbers:
  • 2016-1099
First Posted:
Aug 14, 2015
Last Update Posted:
Apr 27, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Nadine Sauvé, Researcher of the Mother-Child axis of the CRCHUS, Université de Sherbrooke
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 27, 2021