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

Sponsor

CHU de Quebec-Universite Laval (Other)

Overall Status

Completed

CT.gov ID

NCT00325923

Collaborator

Laval University (Other), Ottawa Hospital Research Institute (Other)

Enrollment

Location

Duration (Months)

34.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Decision Making Choice Behavior Decision Support Techniques Decision Aids	Behavioral: Decision aid	N/A

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single

Official Title:

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

Study Start Date :

Apr 1, 2006

Study Completion Date :

Jun 1, 2006

Outcome Measures

Primary Outcome Measures

Decisional conflict [2 weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 64 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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