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

This study has been completed.
Sponsor:
Collaborators:
Laval University
Ottawa Hospital Research Institute
Information provided by:
Centre Hospitalier Universitaire de Québec, CHU de Québec
ClinicalTrials.gov Identifier:
NCT00325923
First received: May 11, 2006
Last updated: March 24, 2010
Last verified: April 2006
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Official Title: A Patient Decision Aid Regarding Natural Health Products for Menopausal Symptoms:a Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Menopause
U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Québec, CHU de Québec:

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

Secondary Outcome Measures:
  • Knowledge [ Time Frame: 2 weeks ]
  • Persistence for an option [ Time Frame: 2 weeks ]
  • Intention to use for a future decision in the same area [ Time Frame: 2 weeks ]
  • Intention to disclose use of natural health products to health professionals [ Time Frame: 2 weeks ]

Estimated Enrollment: 70
Study Start Date: April 2006
Estimated Study Completion Date: June 2006
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.

  Eligibility

Ages Eligible for Study:   45 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00325923

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

No publications provided by Centre Hospitalier Universitaire de Québec, CHU de Québec

Additional 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
Study First Received: May 11, 2006
Last Updated: March 24, 2010
Health Authority: Canada: Health Canada

Keywords provided by Centre Hospitalier Universitaire de Québec, CHU de Québec:
Decision making
Decision support
Decisional conflict
Menopause
 Natural health products
Herbs
Complementary medicine
Complementary therapies

ClinicalTrials.gov processed this record on May 23, 2013