DiabetesCHECNCT00791453
Clarksdale Diabetes and Metabolism Clinic CHEC Study
An observational study of Diabetes, run by University of Mississippi Medical Center at 1 site in United States.
Trial summary
This study will involve established clinic patients. The Rapid Estimate of Adult Literacy in Medicine will be administered during patients' regular clinic visits. Patients will then be referred to the Consumer Health Education Center (CHEC)by healthcare providers who will fill out a referral form. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Feb 2009
- Phase
- Observational
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: Established patients at a diabetes clinic.
Who may be able to join
- Established patients of the Clarksdale Diabetes and Metabolism Clinic between the ages of 18 and 64.
Who cannot join
- Individuals who are not established patients of the clinic and are not between the ages of 18 and 64.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Mississippi Medical Center
Jackson, Mississippi, 39216
About this study
Official title: Clarksdale Diabetes and Metabolism Clinic Consumer Health Education Center Study
This study will involve established clinic patients. The Rapid Estimate of Adult Literacy in Medicine will be administered during patients' regular clinic visits. Patients will then be referred to the Consumer Health Education Center (CHEC)by healthcare providers who will fill out a referral form. The form will be given the the CHEC health educator who will assist patients in finding literacy-appropriate health information. BMI and Hgb A1c values will be compared after 3 months and 6 months to baseline values. It is hypothesized that objective assessment of patient use of literacy-appropriate, health information from the Clarksdale Diabetes and Metabolism Clinic CHEC will improve Hgb A1c and BMI values among patients.
- Conditions
- Diabetes
- Being tested
- Education
- Keywords
- Diabetic patients at the Clarksdale Diabetes, and Metabolism Clinic and must be between the, ages of 18 and 64 years of age.
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
Patients will receive literacy appropriate health information.
| Study group | Role | What they receive |
|---|---|---|
| I | Established patients at the Clarksdale Diabetes and Metabolism Center Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hgb A1C and BMI measurements will improve
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2008 (estimated)
- Study startApr 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Library of Medicine (NLM)
- Investigators
- Jacinda B. Roach, PhD, Principal investigator, The University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00791453
- Sponsor's protocol ID
- 2008-0001
- Other IDs
- NO1-LM-6-3502
- Acronym
- CHEC
- Status last verified
- May 2009
- First submitted
- 28 Jan 2008
- Last updated
- 12 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clarksdale Diabetes and Metabolism Clinic Consumer Health Education Center Study
- ClinicalTrials.gov ID
- NCT00791453
- Acronym / sponsor ID
- CHEC / 2008-0001
- Conditions
- Diabetes
- Keywords
- Diabetic patients at the Clarksdale Diabetes, and Metabolism Clinic and must be between the, ages of 18 and 64 years of age.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Collaborators
- National Library of Medicine (NLM)
- Study start
- Apr 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 14 Nov 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.
This study will involve established clinic patients. The Rapid Estimate of Adult Literacy in Medicine will be administered during patients' regular clinic visits. Patients will then be referred to the Consumer Health Education Center (CHEC)by healthcare providers who will fill out a referral form. The form will be given the the CHEC health educator who will assist patients in finding literacy-appropriate health information. BMI and Hgb A1c values will be compared after 3 months and 6 months to baseline values. It is hypothesized that objective assessment of patient use of literacy-appropriate, health information from the Clarksdale Diabetes and Metabolism Clinic CHEC will improve Hgb A1c and BMI values among patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I | – | Behavioral: EducationEstablished patients at the Clarksdale Diabetes and Metabolism Center |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Established patients at a diabetes clinic.
Key inclusion criteria (1 listed)
- Established patients of the Clarksdale Diabetes and Metabolism Clinic between the ages of 18 and 64.
Key exclusion criteria (1 listed)
- Individuals who are not established patients of the clinic and are not between the ages of 18 and 64.
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 |
|---|---|---|
| EducationPatients will receive literacy appropriate health information. | Behavioural | I |
Primary outcome
Hgb A1C and BMI measurements will improve
Time frame: 3 and 6 months
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 12 May 2009.
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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.
Jacinda B. Roach, PhD principal investigator
The University of Mississippi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by University of Mississippi 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 12 May 2009. 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?
Hgb A1C and BMI measurements will improve (time frame: 3 and 6 months). 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 12 May 2009.