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

Decision Making Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00325923
• Other study ID #: 5-06-03-01
• Status: Completed
• Phase: N/A
• First received: May 11, 2006
• Last updated: March 24, 2010
• Start date: April 2006
• Est. completion date: June 2006

Study information

• Verified date: April 2006
• Source: Centre Hospitalier Universitaire de Québec, CHU de Québec
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 64 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind

Related Conditions & MeSH terms

• Choice Behavior
• Decision Aids
• Decision Making
• Decision Support Techniques

Intervention

Behavioral:
• Decision aid

Locations

Country	Name	City	State
Canada	Hôpital St-François d'Assise-CHUQ	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Québec, CHU de Québec	Laval University, Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decisional conflict		2 weeks
Secondary	Knowledge		2 weeks
Secondary	Persistence for an option		2 weeks
Secondary	Intention to use for a future decision in the same area		2 weeks
Secondary	Intention to disclose use of natural health products to health professionals		2 weeks