A Patient Decision Aid Regarding Natural Health Products for Menopausal Symptoms:a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Decisional conflict
研究概览
简要总结
The aim of this study is to assess the impact of a patient decision aid regarding natural health products for menopausal symptoms on decisional conflict, knowledge and persistence for an option of women aged 45-64 years old. We are expecting a decrease in decisional conflict and an improvement on knowledge level. We are also expecting an intention to use the decision aid in the future and to discuss with the physician or pharmacist about the use, or the intention to use natural health products.
详细描述
Health decision making is a process known to be difficult, specially in uncertainty context. Because of a lack of evidence, natural health products field remains uncertain. Decision aids (or decision support interventions) have been elaborated in the past for several health decisions and previous studies showed that they seem to be effective on reducing decisional conflict. Following a needs assessment with 40 women and 15 key informants, we developed a decision aid tool specific to the context of natural health products for menopause. In this study, we will assess its impact on decisional conflict, knowledge, persistence for an option, intention to use for a future decision in the same area, and intention to disclose use of natural health products to health professionals.
Comparison: An existing general information brochure on menopause compared to a decision aid tool that we developed based on the Ottawa Decision Support Framework.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single
入排标准
- 年龄范围
- 45 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •between 45 and 64 years old
- •reporting suffering from menopausal symptoms
- •considering the use of natural health products for menopausal symptoms
- •able to read, write, and understand french at a grade 8 level
- •able to give an informed consent for her participation to the study
排除标准
- •manager and/or owner of a natural health products store,a pharmacy and/or a pharmaceutical company
- •person with close relationships with one or many collaborators of this study
- •reporting suffering from symptoms with no precise diagnosis
结局指标
主要结局
Decisional conflict
时间窗: 2 weeks
次要结局
- Knowledge(2 weeks)
- Persistence for an option(2 weeks)
- Intention to use for a future decision in the same area(2 weeks)
- Intention to disclose use of natural health products to health professionals(2 weeks)