HealthyPhase 3NCT00753857
The Drug Facts Box: Helping Consumers Understand Drugs for Risk Reduction
A Phase 3 study testing Drug Facts Box and Standard Brief Summary in people with Healthy, run by White River Junction Veterans Affairs Medical Center at 1 site in United States.
Trial summary
RATIONALE: The way in which information about a drug is provided may affect the ability of patients and doctors to understand how a drug works and the side effects of the drug. PURPOSE: This randomized trial is studying how well a drug facts page works compared with a short drug summary in helping patients and doctors… Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Drug Facts Box and Standard Brief Summary
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to May 2007
- Phase
- Phase 3
- 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 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 35-70 year old in household selected by random digit dialing
Who cannot join
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Medical Center
White River Junction, Vermont, 05009
About this study
RATIONALE:
The way in which information about a drug is provided may affect the ability of patients and doctors to understand how a drug works and the side effects of the drug.
PURPOSE:
This randomized trial is studying how well a drug facts page works compared with a short drug summary in helping patients and doctors understand medical information.
Read the detailed description
This is a randomized study. Participants are contacted by phone via random-digit dialing for initial interview using the computer-assisted telephone interviewing (CATI) system. Eligible participants are then randomized to 1 of 2 intervention arms.
- Compare the effect of a prescription drug summary (one-page summary of drug information that includes a table with data on drug benefit and side effects) vs standard brief summary in direct-to-consumer advertisements on the comparisons of two drugs for the same indication, knowledge of drug efficacy and side effects of each drug, perceptions of drug efficacy and side effects of each drug
- Comprehension of information contained in the drug facts box
- Conditions
- Healthy
- Being tested
- Drug Facts Box, Standard Brief Summary
- Keywords
- risk communication, probability sample by random digit dialing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug Facts BoxOther
Educational intervention of 1 page summary of drug efficacy and side effects
Standard Brief SummaryOther
Ads consisted of the standard second page called the brief summary
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants received 2 ads for drugs to reduce cardiovascular risk with drug facts boxes second pages. Receives: Other: Drug Facts Box |
| 2 | Active comparator | Participants receive the same 2 advertisements for drugs to reduce cardiovascular risk with the standard second page (i.e., brief summary) Receives: Other: Standard Brief Summary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of two drugs for the same indication, Knowledge and judgments about 2 drugs to reduce the future risk of cardiovascular events
Measured: Immediate return of patient survey
Secondary outcomes (1)
Comprehension of information contained in the drug facts box
Measured: Immediate return of patient survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2008 (estimated)
- Study startOct 2006
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- White River Junction Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Steven Woloshin, MD, MS, Principal investigator, Dartmouth Medical School; VA Medical Center (WRJ)Lisa M Schwartz, MD, MS, Principal investigator, Dartmouth Medical School, VA Medical Center (WRJ)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00753857
- Sponsor's protocol ID
- DMS-15879-2
- Other IDs
- NCT00386932
- Status last verified
- Sep 2008
- First submitted
- 16 Sep 2008
- Last updated
- 17 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Drug Facts Box: Helping Consumers Understand Drugs for Risk Reduction
- ClinicalTrials.gov ID
- NCT00753857
- Acronym / sponsor ID
- DMS-15879-2
- Conditions
- Healthy
- Keywords
- risk communication, probability sample by random digit dialing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- White River Junction Veterans Affairs Medical CenterUS federal agency
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2006
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 17 Sep 2008 (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.
RATIONALE:
The way in which information about a drug is provided may affect the ability of patients and doctors to understand how a drug works and the side effects of the drug.
PURPOSE:
This randomized trial is studying how well a drug facts page works compared with a short drug summary in helping patients and doctors understand medical information.
Detailed description
This is a randomized study. Participants are contacted by phone via random-digit dialing for initial interview using the computer-assisted telephone interviewing (CATI) system. Eligible participants are then randomized to 1 of 2 intervention arms.
- Compare the effect of a prescription drug summary (one-page summary of drug information that includes a table with data on drug benefit and side effects) vs standard brief summary in direct-to-consumer advertisements on the comparisons of two drugs for the same indication, knowledge of drug efficacy and side effects of each drug, perceptions of drug efficacy and side effects of each drug
- Comprehension of information contained in the drug facts box
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Drug Facts BoxParticipants received 2 ads for drugs to reduce cardiovascular risk with drug facts boxes second pages. |
| 2 | Active comparator | Other: Standard Brief SummaryParticipants receive the same 2 advertisements for drugs to reduce cardiovascular risk with the standard second page (i.e., brief summary) |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 35-70 year old in household selected by random digit dialing
Key exclusion criteria (1 listed)
- Non-English speaking
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 |
|---|---|---|
| Drug Facts BoxEducational intervention of 1 page summary of drug efficacy and side effects | Other | 1 |
| Standard Brief SummaryAds consisted of the standard second page called the brief summary | Other | 2 |
Primary outcome
Comparison of two drugs for the same indication, Knowledge and judgments about 2 drugs to reduce the future risk of cardiovascular events
Time frame: Immediate return of patient survey
1 secondary outcome
Comprehension of information contained in the drug facts box
Time frame: Immediate return of patient survey
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 17 Sep 2008.
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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.
Steven Woloshin, MD, MS principal investigator
Dartmouth Medical School; VA Medical Center (WRJ)
Lisa M Schwartz, MD, MS principal investigator
Dartmouth Medical School, VA Medical Center (WRJ)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Drug Facts Box and Standard Brief Summary in people with Healthy, run by White River Junction Veterans Affairs Medical Center 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 1 inclusion and 1 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 17 Sep 2008. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Comparison of two drugs for the same indication, Knowledge and judgments about 2 drugs to reduce the future risk of cardiovascular events (time frame: Immediate return of patient survey). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2008.