MenopauseNCT01152294

Measuring Quality of Decisions About Treatment of Menopausal Symptoms

A study testing DVD & Booklet called: Managing Menopause in people with Menopause, run by University of Massachusetts, Boston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this randomized controlled trial is to examine the impact of a patient decision aid on the quality of decisions about managing symptoms of menopause. In particular, we will examine whether the decision aid increases knowledge about menopause/managing menopause symptoms and concordance between goals and… Read more about this study

Who is it for?: Ages 40 to 60 years, women only
Conditions the study is for: Menopause
What is being tested?: DVD & Booklet called: Managing Menopause
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 401 participants
Where: 1 siteUnited States
Study dates: Jun 2010to Nov 2010
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 40 to 60 years
Women only
No healthy volunteers
Adult

Who may be able to join

Female, aged 40-60
Talked with health care provider about ways to manage menopause within last year OR seriously considered taking medicine or supplement to manage menopause within the last year

Who cannot join

Prior diagnosis of breast cancer
Surgical or medically induced menopause (ovaries removed)

Trial locations and contacts

1 site in 1 country.

United States1 site

Center for Survey Research - University of Massachusetts Boston
Boston, Massachusetts, 02125

Other trials in United States

About this study

Conditions: Menopause
Being tested: DVD & Booklet called: Managing Menopause
Keywords: Menopause, Decision making, Decision aids, Decision quality instrument

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DVD & Booklet called: Managing MenopauseBehavioural
Also called Decision aids, Shared decision making programs
DVD and booklet that provides information about treatment choices for menopause symptoms. Complete title: Managing Menopause: Choosing treatments for menopause symptoms

Study groups in NCT01152294
Study group	Role	What they receive
Control	No intervention	Group not receiving the decision aid (DVD and booklet)
Decision Aid	Experimental	Group receiving the decision aid (DVD/booklet) Receives: Behavioral: DVD & Booklet called: Managing Menopause

What is being measured

The primary outcome is the main question the study is designed to answer.

Menopause Knowledge
Total knowledge score from factual questions about menopause and methods for managing menopause symptoms. Score is the percent of knowledge questions answered correctly (0 - 100%)
Measured: 2 weeks, on average

Secondary outcomes (1)

Value Concordance
Measure of how concordant respondents' actual decisions about treatment for their menopause symptoms are with their stated beliefs
Measured: 2 weeks, on average

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2010Nov 2010

First posted29 Jun 2010 (estimated)
Study startJun 2010
Primary completionSep 2010
Study completionNov 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for MenopauseStudies 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
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 401 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01152294
Sponsor's protocol ID: CSR-DQ1-001
Status last verified: Jul 2012
First submitted: 22 Jun 2010
Last updated: 20 Aug 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Menopause trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Measuring Quality of Decisions About Treatment of Menopausal Symptoms
ClinicalTrials.gov ID: NCT01152294
Acronym / sponsor ID: CSR-DQ1-001
Conditions: Menopause
Keywords: Menopause, Decision making, Decision aids, Decision quality instrument
Study type: Interventional
Recruitment status: Completed
Enrolment: 401 participants (actual)
Lead sponsor: University of Massachusetts, BostonUniversity, hospital or other
Collaborators: Foundation for Informed Medical Decision Making, Massachusetts General Hospital
Study start: Jun 2010
Primary completion: Sep 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 29 Jun 2010 (estimated)
Results: Posted 20 Aug 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Control	No intervention	–Group not receiving the decision aid (DVD and booklet)
Decision Aid	Experimental	Behavioral: DVD & Booklet called: Managing MenopauseGroup receiving the decision aid (DVD/booklet)

Who may qualify

Ages: 40 to 60 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Female, aged 40-60
Talked with health care provider about ways to manage menopause within last year OR seriously considered taking medicine or supplement to manage menopause within the last year

Key exclusion criteria (2 listed)

Prior diagnosis of breast cancer
Surgical or medically induced menopause (ovaries removed)

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
DVD & Booklet called: Managing MenopauseAlso: Decision aids, Shared decision making programsDVD and booklet that provides information about treatment choices for menopause symptoms. Complete title: Managing Menopause: Choosing treatments for menopause symptoms	Behavioural	Decision Aid

Primary outcome

Menopause Knowledge
Time frame: 2 weeks, on average
Total knowledge score from factual questions about menopause and methods for managing menopause symptoms. Score is the percent of knowledge questions answered correctly (0 - 100%)

1 secondary outcome

Value Concordance
Time frame: 2 weeks, on average

Results and safety

Results posted to the registry on 20 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control	213	213
Decision Aid	188	188

Primary outcome: Menopause Knowledge

Time frame: 2 weeks, on average. Mean (Standard Deviation). Unit: Percentage (0-100%)

Measure	Control n = 199	Decision Aid n = 182
Value	51.3 (16.0)	55.8 (18.4)

Control vs Decision Aid: Mean Difference (Net): 4.6 (95% CI 1.02 to 7.96), p = 0.01, t-test, 2 sided

Population analysed: Participants were randomized to not receive the decision aid (DVD and booklet)or to receive the decision aid and booklet.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: August 10, 2010 to December 2, 2010. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	0 of 213 (0%)	0 of 213 (0%)	Not reported
Decision Aid	0 of 188 (0%)	0 of 188 (0%)	Not reported

Limitations and caveats (from the sponsor): Participants who answered less than half the knowledge questions do not have a total knowledge score (primary outcome).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Menopause

Recruiting
Hop Extract Versus Soy Isoflavone Extract for Menopausal Symptoms (HOPES)
Menopause, Perimenopause
Not yet recruiting
The Role of Diet Quality in Sleep Among Women in Postmenopause
Post Menopausal Women
Active, not recruitingPhase 3
Human Menopausal Gonadotropin Research in Infertility Assessing Cumulative Live Birth With Frozen Embryo Transfer.
Infertility (IVF Patients)
Not yet recruiting
Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
Frozen Shoulder, Adhesive Capsulitis
RecruitingObservational study
Observational Study of Bone Complications in People With Post-menopausal Breast Cancer Who Have Stopped Treatment With Denosumab and Aromatase Inhibitors
Breast Cancer

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.

Patricia M Gallagher, PhD study director

University of Massachusetts, Boston

Karen R Sepucha, PhD principal investigator

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing DVD & Booklet called: Managing Menopause in people with Menopause, run by University of Massachusetts, Boston at 1 site in United States.

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 2 inclusion and 2 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 20 Aug 2012. 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 United States. 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?

Yes. Results are posted in the registry (first posted 20 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Menopause Knowledge (time frame: 2 weeks, on average). 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 NCT01152294.

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 20 Aug 2012.