Health LiteracyNCT01103986
Assessing the Effectiveness of a Health Literacy Intervention in the Workplace
A study testing Motivational/health literacy education (Test group) in people with Health Literacy, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of a health literacy/motivational intervention in a workplace setting. Parents will be taught how to use a child health book to lessen inappropriate use of physician services and improve parent confidence in their ability to identify and obtain necessary… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Literacy
- What is being tested?
- Motivational/health literacy education (Test group)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Nov 2010
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- currently employed at the Children's Mercy Hospitals and Clinics, MO or KS, or working under contract
- parent/legally authorized representative/primary care giver taking care of a child birth to 12 years old
Who cannot join
- non-English speaking and reading
- under 18 years old unless a minor parent
- a medical or nursing degree (MD, DO, Physician's Assistant, Nurse Practitioner, RN or LPN)
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
About this study
Official title: Assessing the Effectiveness of a Health Literacy Intervention in the Workplace: A Quasi-experimental Pre-post Randomized Controlled Study
The purpose of this study is to evaluate the effectiveness of a health literacy/motivational intervention in a workplace setting. Parents will be taught how to use a child health book to lessen inappropriate use of physician services and improve parent confidence in their ability to identify and obtain necessary assistance when their children are ill.
- Conditions
- Health Literacy
- Being tested
- Motivational/health literacy education (Test group)
- Keywords
- health literacy, consumer health information, patient education as topics/methods, patient participation
- Medical subject headings
- Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational/health literacy education (Test group)Behavioural
Attend a 1-hour class to learn how to use the book "What to Do When Your Child Gets Sick."
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Not described |
| motivational/ health literacy education | Experimental | Not described Receives: Behavioral: Motivational/health literacy education (Test group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of non emergency room clinician visits
Determine if parents/primary caregivers' attendance at a class to learn how to use a child health book leads to fewer non-emergency room clinician visits for their children.
Measured: within 1 week prior to class and 90 days post-class
Secondary outcomes (2)
number of emergency department visits
To determine if parents/primary caregivers attending a class to learn how to use a child health book leads to fewer emergency department visits
Measured: within 1 week prior to class and 90 days post-class
pre and post intervention measures of self-identified competency.
To assess feelings of parents/primary caregiver competence in appropriately managing their children's illnesses using pre and post intervention measures of self-identified competency.
Measured: within 1 week prior to class and 90 days post-class
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2010 (estimated)
- Study startJan 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Health LiteracyStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nancy A Neilan, MT (ASCP), Principal investigator, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01103986
- Sponsor's protocol ID
- 0912-255X
- Status last verified
- Dec 2020
- First submitted
- 1 Feb 2010
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Bryan C. Provider and policy response to reverse the consequences of low health literacy. J Healthc Manag. 2008 Jul-Aug;53(4):230-41.
PubMed 18720685Ensuring Positive Health Outcomes in Head Start Children and Famiies Pilot Study, Executive Summary. Herman A, September 2002
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effectiveness of a Health Literacy Intervention in the Workplace: A Quasi-experimental Pre-post Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01103986
- Acronym / sponsor ID
- 0912-255X
- Conditions
- Health Literacy
- Keywords
- health literacy, consumer health information, patient education as topics/methods, patient participation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 15 Apr 2010 (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 purpose of this study is to evaluate the effectiveness of a health literacy/motivational intervention in a workplace setting. Parents will be taught how to use a child health book to lessen inappropriate use of physician services and improve parent confidence in their ability to identify and obtain necessary assistance when their children are ill.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | – |
| motivational/ health literacy education | Experimental | Behavioral: Motivational/health literacy education (Test group) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- currently employed at the Children's Mercy Hospitals and Clinics, MO or KS, or working under contract
- parent/legally authorized representative/primary care giver taking care of a child birth to 12 years old
Key exclusion criteria (3 listed)
- non-English speaking and reading
- under 18 years old unless a minor parent
- a medical or nursing degree (MD, DO, Physician's Assistant, Nurse Practitioner, RN or LPN)
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 |
|---|---|---|
| Motivational/health literacy education (Test group)Attend a 1-hour class to learn how to use the book "What to Do When Your Child Gets Sick." | Behavioural | motivational/ health literacy education |
Primary outcome
number of non emergency room clinician visits
Time frame: within 1 week prior to class and 90 days post-class
Determine if parents/primary caregivers' attendance at a class to learn how to use a child health book leads to fewer non-emergency room clinician visits for their children.
2 secondary outcomes
number of emergency department visits
Time frame: within 1 week prior to class and 90 days post-class
pre and post intervention measures of self-identified competency.
Time frame: within 1 week prior to class and 90 days post-class
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 Dec 2020.
- Background: PubMed 18720685Bryan C. Provider and policy response to reverse the consequences of low health literacy. J Healthc Manag. 2008 Jul-Aug;53(4):230-41.
- BackgroundEnsuring Positive Health Outcomes in Head Start Children and Famiies Pilot Study, Executive Summary. Herman A, September 2002
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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.
Nancy A Neilan, MT (ASCP) principal investigator
Children's Mercy Hospital Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational/health literacy education (Test group) in people with Health Literacy, run by Children's Mercy Hospital Kansas City 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 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 17 Dec 2020. 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?
number of non emergency room clinician visits (time frame: within 1 week prior to class and 90 days post-class). 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 NCT01103986, which also lists 2 linked publications.
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 Dec 2020.