Health LiteracyNCT01474733
Effects of a Longitudinal Health Literacy Training Program on Family Medicine Residents
A study testing educational intervention in people with Health Literacy, run by Oregon Health and Science University at 1 site in United States.
Trial summary
1. Briefly describe the purpose of this protocol: This study is designed to evaluate the effectiveness of an educational training program on the topic of health literacy for Family Medicine residents. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Literacy
- What is being tested?
- educational intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Jul 2014
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -Family medicine resident entering in summer 2011 at OHSU Department of Family Medicine
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
- Briefly describe the purpose of this protocol: This study is designed to evaluate the effectiveness of an educational training program on the topic of health literacy for Family Medicine residents. The hypothesis being tested is that training residents about health literacy will result in improvements in residents' knowledge, skills, and attitudes with respect to health literacy.
- Briefly summarize how participants are recruited: OHSU Family Medicine Interns attending mandatory trainings on the topic of health literacy throughout the three years of the residency program will be invited to participate in the study.
- Briefly describe the procedures subjects will undergo: Completion of a short self-administered anonymous survey before and after a variety of learning sessions on the topic of health literacy.
- If applicable, briefly describe survey/interview instruments used: A 12-item pre-test questionnaire and 13-item post-test questionnaire designed to assess individuals' knowledge about health literacy, and intended clinical practices with respect to health literacy.
- If this is a clinical trial using an experimental drug and/or device, or an approved drug and/or device used for an unapproved purpose, briefly describe the drug and/or device: n/a
- Briefly describe how the data will be analyzed to address the purpose of the protocol: Demographics and responses to individual items will be reported as frequencies and percentages within the sample. We will use a chi-square analysis to stratify responses by demographic groups and t-tests to measure possible changes over time
- Conditions
- Health Literacy
- Being tested
- educational intervention
- Keywords
- resident education, health literacy, curriculum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational interventionOther
series of lectures and workshops on health literacy
| Study group | Role | What they receive |
|---|---|---|
| educational intervention | Experimental | participants undergo a series of educational interventions over 3 years Receives: Other: educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
knowledge about health literacy
as measured by a standardized questionnaire
Measured: 3 years
Secondary outcomes (1)
clear communication skills
As measured by performance on an OSCE
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health LiteracyStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cliff Coleman, Oregon Health and Science University
- Investigators
- Clifford A Coleman, MD, MPH, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01474733
- Sponsor's protocol ID
- OHSU IRB#00008039
- Status last verified
- Oct 2015
- First submitted
- 15 Nov 2011
- Last updated
- 16 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Longitudinal Health Literacy Training Program on Family Medicine Residents
- ClinicalTrials.gov ID
- NCT01474733
- Acronym / sponsor ID
- OHSU IRB#00008039
- Conditions
- Health Literacy
- Keywords
- resident education, health literacy, curriculum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 18 Nov 2011 (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.
- Briefly describe the purpose of this protocol: This study is designed to evaluate the effectiveness of an educational training program on the topic of health literacy for Family Medicine residents. The hypothesis being tested is that training residents about health literacy will result in improvements in residents' knowledge, skills, and attitudes with respect to health literacy.
- Briefly summarize how participants are recruited: OHSU Family Medicine Interns attending mandatory trainings on the topic of health literacy throughout the three years of the residency program will be invited to participate in the study.
- Briefly describe the procedures subjects will undergo: Completion of a short self-administered anonymous survey before and after a variety of learning sessions on the topic of health literacy.
- If applicable, briefly describe survey/interview instruments used: A 12-item pre-test questionnaire and 13-item post-test questionnaire designed to assess individuals' knowledge about health literacy, and intended clinical practices with respect to health literacy.
- If this is a clinical trial using an experimental drug and/or device, or an approved drug and/or device used for an unapproved purpose, briefly describe the drug and/or device: n/a
- Briefly describe how the data will be analyzed to address the purpose of the protocol: Demographics and responses to individual items will be reported as frequencies and percentages within the sample. We will use a chi-square analysis to stratify responses by demographic groups and t-tests to measure possible changes over time
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| educational intervention | Experimental | Other: educational interventionparticipants undergo a series of educational interventions over 3 years |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -Family medicine resident entering in summer 2011 at OHSU Department of Family Medicine
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| educational interventionseries of lectures and workshops on health literacy | Other | educational intervention |
Primary outcome
knowledge about health literacy
Time frame: 3 years
as measured by a standardized questionnaire
1 secondary outcome
clear communication skills
Time frame: 3 years
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 16 Oct 2015.
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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.
Clifford A Coleman, MD, MPH principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educational intervention in people with Health Literacy, run by Oregon Health and Science University 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 0 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 16 Oct 2015. 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?
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?
knowledge about health literacy (time frame: 3 years). 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 16 Oct 2015.