Evaluation of an Information Pamphlet to Improve Knowledge Concerning the Impacts and the Importance of Healthy Lifestyle After a Pregnancy With Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- knowledge improvement (questionnaire with check list and true/false questions).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- 未提供
结局指标
主要结局
knowledge improvement (questionnaire with check list and true/false questions).
时间窗: 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).
次要结局
- Anxiety in the intervention group between baseline and at one month (Likert scale)(4 weeks)
- Perception of cardiovascular risk between the intervention and the control group at one month (Likert scale)(4 weeks)
- Anxiety between the intervention and the control group at one month.(Likert scale)(4 weeks)
- Satisfaction between the intervention and the control group at one month.(Likert scale)(4 weeks)
- Perception of cardiovascular risk in the intervention group between baseline and at one month (Likert scale)(4 weeks)
- Perception of cardiovascular risk between baseline and at one month in the control group. (Likert scale)(4 weeks)
- Satisfaction in the control group between baseline and at one month (Likert scale)(4 weeks)
- Anxiety in the control group between baseline and at one month (Likert scale)(4 weeks)
- Satisfaction in the intervention group between baseline and at one month(Likert scale)(4 weeks)
- Knowledge in the intervention group between baseline and at one month (questionnaire with check list and true/false questions).(4 weeks)
- Knowledge in the control group between baseline and at one month (questionnaire with check list and true/false questions).(4 weeks)
研究者
Nadine Sauvé
Researcher of the Mother-Child axis of the CRCHUS
Université de Sherbrooke