Decision MakingNCT00325923
Impact of a Decision Aid Regarding Natural Health Products for Menopausal Symptoms
A study testing Decision aid in people with Decision Making and Choice Behavior, run by CHU de Quebec-Universite Laval at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Decision Making, Choice Behavior, Decision Support Techniques
- What is being tested?
- Decision aid
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2006to Jun 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Patient Decision Aid Regarding Natural Health Products for Menopausal Symptoms:a Randomized Controlled Trial
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.
- Being tested
- Decision aid
- Keywords
- Decision making, Decision support, Decisional conflict, Menopause, Natural health products, Herbs, Complementary medicine, Complementary therapies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision aidBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional conflict
Measured: 2 weeks
Secondary outcomes (4)
Knowledge
Measured: 2 weeks
Persistence for an option
Measured: 2 weeks
Intention to use for a future decision in the same area
Measured: 2 weeks
Intention to disclose use of natural health products to health professionals
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2006 (estimated)
- Study startApr 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Decision MakingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 70 participants
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Collaborators
- Laval University, Ottawa Hospital Research Institute
- Investigators
- France Legare, MD, PhD,, Principal investigator, CHU de Quebec-Universite Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00325923
- Sponsor's protocol ID
- 5-06-03-01
- Status last verified
- Apr 2006
- First submitted
- 11 May 2006
- Last updated
- 25 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Patient Decision Aid Regarding Natural Health Products for Menopausal Symptoms:a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00325923
- Acronym / sponsor ID
- 5-06-03-01
- Keywords
- Decision making, Decision support, Decisional conflict, Menopause, Natural health products, Herbs, Complementary medicine, Complementary therapies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Collaborators
- Laval University, Ottawa Hospital Research Institute
- Study start
- Apr 2006
- Study completion
- Jun 2006
- First posted
- 15 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 45 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision aid | Behavioural | – |
Primary outcome
Decisional conflict
Time frame: 2 weeks
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2010.
- Derived from this study: PubMed 18714075Legare 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.
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Healthy Volunteers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
France Legare, MD, PhD, principal investigator
CHU de Quebec-Universite Laval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision aid in people with Decision Making and Choice Behavior, run by CHU de Quebec-Universite Laval at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decisional conflict (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00325923, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2010.