Hypertension, Pregnancy-InducedNCT02523781
Evaluation of an Information Pamphlet for Postpartum Women That Had a Hypertensive Pregnancy
A study testing information pamphlet in people with Hypertension, Pregnancy-Induced, run by Université de Sherbrooke at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Pregnancy-Induced
- What is being tested?
- information pamphlet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2015to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not able to read and write in French.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hopitalier Universiatire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
About this study
Official title: Evaluation of an Information Pamphlet to Improve Knowledge Concerning the Impacts and the Importance of Healthy Lifestyle After a Pregnancy With Hypertension
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.
Read the 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.
- Conditions
- Hypertension, Pregnancy-Induced
- Being tested
- information pamphlet
- Keywords
- preeclampsia, information pamphlet, patient education
- Medical subject headings
- Hypertension, Pregnancy-Induced, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
information pamphletOther
The intervention group receives the information pamphlet
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The control group does not receive the information pamphlet |
| Intervention group | Experimental | The intervention group receives the information pamphlet Receives: Other: information pamphlet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 weeks
Secondary outcomes (11)
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.
Measured: 4 weeks
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.
Measured: 4 weeks
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.
Measured: 4 weeks
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.
Measured: 4 weeks
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.
Measured: 4 weeks
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.
Measured: 4 weeks
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
Measured: 4 weeks
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.
Measured: 4 weeks
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.
Measured: 4 weeks
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).
Measured: 4 weeks
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).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startJun 2015
- Primary completion20 Aug 2017
- Study completionJul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, Pregnancy-InducedStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadine Sauvé, Université de Sherbrooke
- Investigators
- Sauvé Nadine, MD, Principal investigator, Université de SherbrookeAnne-Marie côté, MD, Study chair, Université de SherbrookeAnnabelle Cumyn, MD, Study chair, Université de SherbrookeMarie-Eve Roy-Lacroix, MD, Study chair, Université de SherbrookeMyriam Champagne, MD, Study chair, Université de SherbrookeMarie-Hélène Pesant, MD, Study chair, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02523781
- Sponsor's protocol ID
- 2016-1099
- Status last verified
- Apr 2021
- First submitted
- 30 Jul 2015
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Information Pamphlet to Improve Knowledge Concerning the Impacts and the Importance of Healthy Lifestyle After a Pregnancy With Hypertension
- ClinicalTrials.gov ID
- NCT02523781
- Acronym / sponsor ID
- 2016-1099
- Conditions
- Hypertension, Pregnancy-Induced
- Keywords
- preeclampsia, information pamphlet, patient education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- 20 Aug 2017 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 14 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The control group does not receive the information pamphlet |
| Intervention group | Experimental | Other: information pamphletThe intervention group receives the information pamphlet |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Not able to read and write in French.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| information pamphletThe intervention group receives the information pamphlet | Other | Intervention group |
Primary outcome
knowledge improvement (questionnaire with check list and true/false questions).
Time frame: 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).
11 secondary outcomes
Perception of cardiovascular risk between the intervention and the control group at one month (Likert scale)
Time frame: 4 weeks
Anxiety between the intervention and the control group at one month.(Likert scale)
Time frame: 4 weeks
Satisfaction between the intervention and the control group at one month.(Likert scale)
Time frame: 4 weeks
Perception of cardiovascular risk in the intervention group between baseline and at one month (Likert scale)
Time frame: 4 weeks
Perception of cardiovascular risk between baseline and at one month in the control group. (Likert scale)
Time frame: 4 weeks
Anxiety in the intervention group between baseline and at one month (Likert scale)
Time frame: 4 weeks
Anxiety in the control group between baseline and at one month (Likert scale)
Time frame: 4 weeks
Satisfaction in the intervention group between baseline and at one month(Likert scale)
Time frame: 4 weeks
Satisfaction in the control group between baseline and at one month (Likert scale)
Time frame: 4 weeks
Knowledge in the intervention group between baseline and at one month (questionnaire with check list and true/false questions).
Time frame: 4 weeks
Knowledge in the control group between baseline and at one month (questionnaire with check list and true/false questions).
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Hypertension, Pregnancy-Induced
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Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
RecruitingPhase 3
Preeclampsia Intervention Netherlands
Pre-Eclampsia Onset Less Than 37 Weeks, Pre-Eclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sauvé Nadine, MD principal investigator
Université de Sherbrooke
Anne-Marie côté, MD study chair
Université de Sherbrooke
Annabelle Cumyn, MD study chair
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing information pamphlet in people with Hypertension, Pregnancy-Induced, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
knowledge improvement (questionnaire with check list and true/false questions). (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021.