Clinical trial NCT00325923: Impact of a Decision Aid Regarding Natural Health Products for Menopausal Symptoms
Official title: A Patient Decision Aid Regarding Natural Health Products for Menopausal Symptoms:a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Decision Making
Choice Behavior
Decision Support Techniques
Decision Aids
Keywords: Decision making
Decision support
Decisional conflict
Menopause
Natural health products
Herbs
Complementary medicine
Complementary therapies
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
Collaborators: name: Laval University
name: Ottawa Hospital Research Institute
First posted: 2006-05-15
Enrollment: 70
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Decisional conflict
timeFrame: 2 weeks
Secondary outcomes:
measure: Knowledge
timeFrame: 2 weeks
measure: Persistence for an option
timeFrame: 2 weeks
measure: Intention to use for a future decision in the same area
timeFrame: 2 weeks
measure: Intention to disclose use of natural health products to health professionals
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Hôpital St-François d'Assise-CHUQ
Study officials:
affiliation: CHU de Quebec-Universite Laval
name: France Legare, MD, PhD,
role: PRINCIPAL_INVESTIGATOR
References:
citation: Legare F, Dodin S, Stacey D, Leblanc A, Tapp S. Patient decision aid on natural health products for menopausal symptoms: randomized controlled trial. Menopause Int. 2008 Sep;14(3):105-10. doi: 10.1258/mi.2008.008014.