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

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ClinicalTrials.gov Identifier: NCT00325923
Recruitment Status : Completed
First Posted : May 15, 2006
Last Update Posted : March 25, 2010
Information provided by:

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
Decision Making Choice Behavior Decision Support Techniques Decision Aids Behavioral: Decision aid

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  (Clinical Trial)
Estimated Enrollment : 70 participants
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 : April 2006
Estimated Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Decisional conflict [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 64 Years   (Adult)
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00325923

Hôpital St-François d'Assise-CHUQ
Quebec, Canada, G1L 3L5
Sponsors and Collaborators
CHU de Quebec-Universite Laval
Laval University
Ottawa Hospital Research Institute
Principal Investigator: France Legare, MD, PhD, CHU de Quebec-Universite Laval
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00325923     History of Changes
Other Study ID Numbers: 5-06-03-01
First Posted: May 15, 2006    Key Record Dates
Last Update Posted: March 25, 2010
Last Verified: April 2006

Keywords provided by CHU de Quebec-Universite Laval:
Decision making
Decision support
Decisional conflict
Natural health products
Complementary medicine
Complementary therapies