Evaluation of an Information Pamphlet for Postpartum Women That Had a Hypertensive Pregnancy
Primary Purpose
Hypertension, Pregnancy-Induced
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
information pamphlet
Sponsored by
About this trial
This is an interventional supportive care trial for Hypertension, Pregnancy-Induced focused on measuring preeclampsia, information pamphlet, patient education
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.
Sites / Locations
- Centre Hopitalier Universiatire de Sherbrooke
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Intervention group
Arm Description
The control group does not receive the information pamphlet
The intervention group receives the information pamphlet
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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
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.
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.
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).
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02523781
Brief Title
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
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
August 20, 2017 (Actual)
Study Completion Date
July 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Sherbrooke
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Pregnancy-Induced
Keywords
preeclampsia, information pamphlet, patient education
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group does not receive the information pamphlet
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
The intervention group receives the information pamphlet
Intervention Type
Other
Intervention Name(s)
information pamphlet
Intervention Description
The intervention group receives the information pamphlet
Primary Outcome Measure Information:
Title
knowledge improvement (questionnaire with check list and true/false questions).
Description
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).
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Perception of cardiovascular risk between the intervention and the control group at one month (Likert scale)
Description
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.
Time Frame
4 weeks
Title
Anxiety between the intervention and the control group at one month.(Likert scale)
Description
Comparison of anxiety at one month between the intervention and the control group with a validated Likert scale included in the questionnaire.
Time Frame
4 weeks
Title
Satisfaction between the intervention and the control group at one month.(Likert scale)
Description
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.
Time Frame
4 weeks
Title
Perception of cardiovascular risk in the intervention group between baseline and at one month (Likert scale)
Description
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.
Time Frame
4 weeks
Title
Perception of cardiovascular risk between baseline and at one month in the control group. (Likert scale)
Description
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.
Time Frame
4 weeks
Title
Anxiety in the intervention group between baseline and at one month (Likert scale)
Description
The comparison of anxiety between baseline and at one month in the intervention group with a validated Likert scale included in the questionnaire.
Time Frame
4 weeks
Title
Anxiety in the control group between baseline and at one month (Likert scale)
Description
The comparison of anxiety between baseline and at one month in the control group with a validated Likert scale included in the questionnaire
Time Frame
4 weeks
Title
Satisfaction in the intervention group between baseline and at one month(Likert scale)
Description
The comparison of satisfaction between baseline and at one month in the intervention group with a validated Likert scale included in the questionnaire.
Time Frame
4 weeks
Title
Satisfaction in the control group between baseline and at one month (Likert scale)
Description
The comparison of satisfaction between baseline and at one month in the control group with a validated Likert scale included in the questionnaire.
Time Frame
4 weeks
Title
Knowledge in the intervention group between baseline and at one month (questionnaire with check list and true/false questions).
Description
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).
Time Frame
4 weeks
Title
Knowledge in the control group between baseline and at one month (questionnaire with check list and true/false questions).
Description
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).
Time Frame
4 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sauvé Nadine, MD
Organizational Affiliation
Université de Sherbrooke
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anne-Marie côté, MD
Organizational Affiliation
Université de Sherbrooke
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Annabelle Cumyn, MD
Organizational Affiliation
Université de Sherbrooke
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Marie-Eve Roy-Lacroix, MD
Organizational Affiliation
Université de Sherbrooke
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Myriam Champagne, MD
Organizational Affiliation
Université de Sherbrooke
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Marie-Hélène Pesant, MD
Organizational Affiliation
Université de Sherbrooke
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Hopitalier Universiatire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluation of an Information Pamphlet for Postpartum Women That Had a Hypertensive Pregnancy
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