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

Not Applicable

Completed

• Conditions: Decision Making; Choice Behavior; Decision Support Techniques; Decision Aids

• Registration Number: NCT00325923
• Lead Sponsor: CHU de Quebec-Universite Laval

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.

Study Timeline

• Status Verified: 2006-04
• Study Start: 2006-04
• Study First Submitted: 2006-05-11
• Study First Submitted QC: 2006-05-11
• Study First Posted: 2006-05-15
• Study Completion: 2006-06
• Last Update Submitted: 2010-03-24
• Last Update Posted: 2010-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Decisional conflict	2 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hôpital St-François d'Assise-CHUQ; 🇨🇦 Quebec, Canada