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

NCT ID: NCT00325923

Last Updated: 2010-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2006-06-30

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.

Conditions

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Decision Making Choice Behavior Decision Support Techniques Decision Aids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Interventions

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Decision aid

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

45 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Laval University

OTHER

Sponsor Role collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role collaborator

CHU de Quebec-Universite Laval

OTHER

Sponsor Role lead

Principal Investigators

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France Legare, MD, PhD,

Role: PRINCIPAL_INVESTIGATOR

CHU de Quebec-Universite Laval

Locations

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Hôpital St-François d'Assise-CHUQ

Québec, Quebec, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 18714075 (View on PubMed)

Other Identifiers

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5-06-03-01

Identifier Type: -

Identifier Source: org_study_id

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