NCT00325923

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 11, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 15, 2006

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

March 25, 2010

Status Verified

April 1, 2006

First QC Date

May 11, 2006

Last Update Submit

March 24, 2010

Conditions

Decision MakingChoice BehaviorDecision Support TechniquesDecision Aids

Keywords

Decision makingDecision supportDecisional conflictMenopauseNatural health productsHerbsComplementary medicineComplementary therapies

Outcome Measures

Primary Outcomes (1)

  • Decisional conflict

    2 weeks

Secondary Outcomes (4)

  • 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

Interventions

Decision aidBEHAVIORAL

Eligibility Criteria

Age45 Years - 64 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital St-François d'Assise-CHUQ

Québec, Quebec, G1L 3L5, Canada

Location

Related Publications (1)

  • 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.

    PMID: 18714075DERIVED

MeSH Terms

Interventions

Decision Support Techniques

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • France Legare, MD, PhD,

    CHU de Quebec-Universite Laval

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 11, 2006

First Posted

May 15, 2006

Study Start

April 1, 2006

Study Completion

June 1, 2006

Last Updated

March 25, 2010

Record last verified: 2006-04

Locations

CA(1)