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CompletedNCT00325923Updated Mar 25, 2010

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

An interventional study of Decision aid in Decision Making, Choice Behavior and Decision Support Techniques, sponsored by CHU de Quebec-Universite Laval. Completed at 1 site in Canada. Open to female participants aged 45 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-03-25.

Sponsored by CHU de Quebec-Universite Laval · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
45 Years to 64 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Lead sponsor

CHU de Quebec-Universite Laval is the lead sponsor of 134 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 64 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
70 participants

Interventions

  • BehavioralDecision aid
06

What researchers measure

Primary outcomes

  1. Decisional conflict

    Time frame: 2 weeks

Secondary outcomes

  1. Knowledge

    Time frame: 2 weeks

  2. Persistence for an option

    Time frame: 2 weeks

  3. Intention to use for a future decision in the same area

    Time frame: 2 weeks

  4. Intention to disclose use of natural health products to health professionals

    Time frame: 2 weeks

07

Study locations

1 site
  • Hôpital St-François d'Assise-CHUQ
    Quebec, G1L 3L5, Canada
08

References and documents

Publications

  • 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. PubMed 18714075 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00325923
Lead sponsor
CHU de Quebec-Universite Laval
Collaborators
Laval University, Ottawa Hospital Research Institute
First posted
May 15, 2006
Start date
Apr 2006
Completion
Jun 2006
Last update
Mar 25, 2010

Study contacts

France Legare, MD, PhD,
principal investigator · CHU de Quebec-Universite Laval

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2006. You cannot join it, but the record below documents what was studied.

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