Impact of a Decision Aid Regarding Natural Health Products for Menopausal Symptoms

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Patient Decision Aid Regarding Natural Health Products for Menopausal Symptoms:a Randomized Controlled Trial

Conditions
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Decision Making, Choice Behavior, Decision Support Techniques, Decision Aids

Intervention / Treatment
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* Behavioral: Decision aid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women : 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Decision aid|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decisional conflict |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Decision making, Decision support, Decisional conflict, Menopause, Natural health products, Herbs, Complementary medicine, Complementary therapies