Health Status UnknownNCT00450931
Drug Facts Page or a Short Drug Summary in Helping Patients and Doctors Understand Medical Information
A study testing counseling intervention and educational intervention in people with Health Status Unknown, run by White River Junction Veterans Affairs Medical Center.
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 standard brief summary in helping patients and… Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Status Unknown
- What is being tested?
- counseling intervention and educational intervention
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
DISEASE CHARACTERISTICS:
- English-speaking adults
- Must be able to be chosen by Random Digit Dialing
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: Helping Patients and Physicians Make Sense of Medical Data
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 standard brief summary in helping patients and doctors understand medical information.
Read the detailed description
OBJECTIVES:
Primary
- 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.
Secondary
- Comprehension of information contained in the drug facts box and rating of the usability of the drug information.
OUTLINE: 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 4 intervention arms.
- Arm I: Participants receive 2 advertisements for a drug to treat heartburn with a drug facts second page.
- Arm II: Participants receive 2 advertisements as in arm I for drugs to treat heatburn with the standard second page (i.e., brief summary).
Participants in both arms complete the self-reported questionnaire mailed with the advertisement intervention.
PROJECTED ACCRUAL: A total of 200 participants will be accrued for this study.
- Conditions
- Health Status Unknown
- Being tested
- counseling intervention, educational intervention
- Keywords
- health status unknown
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
counseling interventionOther
educational interventionOther
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 of drug efficacy and side effects of each drug
Secondary outcomes (1)
Comprehension of information contained in the drug facts box and rating of the usability of the drug information
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Status UnknownStudies 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
- Enrolment
- 200 participants (estimated)
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, White River Junction Veterans Affairs Medical CenterHarold Bae, White River Junction Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00450931
- Sponsor's protocol ID
- CDR0000513888
- Other IDs
- VAMC-WRJ-15879, DMS-15879
- Status last verified
- Sep 2008
- First submitted
- 20 Mar 2007
- Last updated
- 6 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helping Patients and Physicians Make Sense of Medical Data
- ClinicalTrials.gov ID
- NCT00450931
- Acronym / sponsor ID
- CDR0000513888
- Conditions
- Health Status Unknown
- Keywords
- health status unknown
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- White River Junction Veterans Affairs Medical CenterUS federal agency
- Collaborators
- National Cancer Institute (NCI)
- First posted
- 22 Mar 2007 (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 standard brief summary in helping patients and doctors understand medical information.
Detailed description
OBJECTIVES:
Primary
- 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.
Secondary
- Comprehension of information contained in the drug facts box and rating of the usability of the drug information.
OUTLINE: 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 4 intervention arms.
- Arm I: Participants receive 2 advertisements for a drug to treat heartburn with a drug facts second page.
- Arm II: Participants receive 2 advertisements as in arm I for drugs to treat heatburn with the standard second page (i.e., brief summary).
Participants in both arms complete the self-reported questionnaire mailed with the advertisement intervention.
PROJECTED ACCRUAL: A total of 200 participants will be accrued for this study.
Study design
- Allocation
- Randomised
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| counseling intervention | Other | – |
| educational intervention | Other | – |
Primary outcome
Comparison of two drugs for the same indication
Knowledge of drug efficacy and side effects of each drug
1 secondary outcome
Comprehension of information contained in the drug facts box and rating of the usability of the drug information
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2014.
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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
White River Junction Veterans Affairs Medical Center
Harold Bae
White River Junction Veterans Affairs Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing counseling intervention and educational intervention in people with Health Status Unknown, run by White River Junction Veterans Affairs Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 6 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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. The study lists 2 primary outcomes in all. 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 6 Jan 2014.