DiabetesNCT00311922
Improving Care for Patients With Diabetes and Poor Numeracy Skills
A study testing Literacy/Numeracy oriented educational intervention in people with Diabetes, run by Vanderbilt University at 1 site in United States.
Trial summary
The aim of this research will be to perform a randomized controlled trial (RCT) of a new diabetes educational intervention that teaches self-management skills that compensate for poor numeracy skills among a sample of patients with diabetes and low numeracy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Literacy/Numeracy oriented educational intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Dec 2007
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Type 1 or 2 Diabetes;
- most recent A1C greater than or equal to 7.0%;
- Referred to the Diabetes Improvement Program for diabetes care;
- Age 18-80;
- English Speaking.
Who cannot join
- Patients with corrected visual Acuity >20/50 using a Rosenbaum Pocket Vision Screener, or
- Patients with a diagnosis of significant dementia, psychosis, or blindness.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
The aim of this research will be to perform a randomized controlled trial (RCT) of a new diabetes educational intervention that teaches self-management skills that compensate for poor numeracy skills among a sample of patients with diabetes and low numeracy.
Read the detailed description
Results of the National Adult Literacy Survey (NALS) suggest that over 90 million adult Americans have poor quantitative skills. Numeracy, the ability to understand and use numbers and math skills in daily life, may be particularly important to patients with diabetes because caring for diabetes often requires self-management skills that rely on the daily application of math skills, such as counting carbohydrates, interpreting blood glucose monitoring, applying sliding scale insulin regimens, and calculating insulin to carbohydrate ratios. Presumably diabetes patients with poor numeracy have more difficulty with self-management and are at risk for poorer clinical outcomes, but to date, there are no published studies that rigorously examine the role of numeracy in diabetes. We have recently completed the initial development of a new scale to measure numeracy in patients with diabetes: the Diabetes Numeracy Test (DNT).
The aim of this research will be to perform a randomized controlled trial (RCT) of a new diabetes educational intervention that teaches self-management skills that compensate for poor numeracy skills among a sample of patients with diabetes and low numeracy. We hypothesize that a group of patients with poor numeracy who are taught self-management skills that accommodate their poor numeracy will have: (1) improved treatment satisfaction and perceived self-efficacy, (2) improved performance in self-management tasks, and (3) improved glycemic control compared to a control group that receives usual education.
- Conditions
- Diabetes
- Being tested
- Literacy/Numeracy oriented educational intervention, Control Group
- Keywords
- Diabetes, Education, Health Literacy
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Literacy/Numeracy oriented educational interventionBehavioural
Comprehensive educational Intervention
Control GroupBehavioural
Receives comprehensive education that is not literacy/numeracy sensitive
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Active Control Arm receives Comprehensive Diabetes Education Receives: Behavioral: Control Group |
| Intervention Arm | Experimental | Receives comprehensive education that is literacy/numeracy sensitive Receives: Behavioral: Literacy/Numeracy oriented educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
A1C
Measured: 3 and 6 months
Secondary outcomes (3)
Patient self-management behaviors
Measured: 3 and 6 months
Patient knowledge
Measured: 6 months
Patient satisfaction
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2006 (estimated)
- Study startMar 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, Vanderbilt DRTC P&F Grant (DK20593), American Diabetes Association
- Investigators
- Russell L Rothman, MD MPP, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00311922
- Sponsor's protocol ID
- IRB# 060128
- Other IDs
- DK20593 P&F 6 NIH/NIDDK
- Status last verified
- Feb 2008
- First submitted
- 4 Apr 2006
- Last updated
- 18 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Cavanaugh K, Wallston KA, Gebretsadik T, Shintani A, Huizinga MM, Davis D, Gregory RP, Malone R, Pignone M, DeWalt D, Elasy TA, Rothman RL. Addressing literacy and numeracy to improve diabetes care: two randomized controlled trials. Diabetes Care. 2009 Dec;32(12):2149-55. doi: 10.2337/dc09-0563. Epub 2009 Sep 9.
PubMed 19741187
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Care for Patients With Diabetes and Poor Numeracy Skills
- ClinicalTrials.gov ID
- NCT00311922
- Acronym / sponsor ID
- IRB# 060128
- Conditions
- Diabetes
- Keywords
- Diabetes, Education, Health Literacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- Pfizer, Vanderbilt DRTC P&F Grant (DK20593), American Diabetes Association
- Study start
- Mar 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 6 Apr 2006 (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 aim of this research will be to perform a randomized controlled trial (RCT) of a new diabetes educational intervention that teaches self-management skills that compensate for poor numeracy skills among a sample of patients with diabetes and low numeracy.
Detailed description
Results of the National Adult Literacy Survey (NALS) suggest that over 90 million adult Americans have poor quantitative skills. Numeracy, the ability to understand and use numbers and math skills in daily life, may be particularly important to patients with diabetes because caring for diabetes often requires self-management skills that rely on the daily application of math skills, such as counting carbohydrates, interpreting blood glucose monitoring, applying sliding scale insulin regimens, and calculating insulin to carbohydrate ratios. Presumably diabetes patients with poor numeracy have more difficulty with self-management and are at risk for poorer clinical outcomes, but to date, there are no published studies that rigorously examine the role of numeracy in diabetes. We have recently completed the initial development of a new scale to measure numeracy in patients with diabetes: the Diabetes Numeracy Test (DNT).
The aim of this research will be to perform a randomized controlled trial (RCT) of a new diabetes educational intervention that teaches self-management skills that compensate for poor numeracy skills among a sample of patients with diabetes and low numeracy. We hypothesize that a group of patients with poor numeracy who are taught self-management skills that accommodate their poor numeracy will have: (1) improved treatment satisfaction and perceived self-efficacy, (2) improved performance in self-management tasks, and (3) improved glycemic control compared to a control group that receives usual education.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Control GroupActive Control Arm receives Comprehensive Diabetes Education |
| Intervention Arm | Experimental | Behavioral: Literacy/Numeracy oriented educational interventionReceives comprehensive education that is literacy/numeracy sensitive |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of Type 1 or 2 Diabetes;
- most recent A1C greater than or equal to 7.0%;
- Referred to the Diabetes Improvement Program for diabetes care;
- Age 18-80;
- English Speaking.
Key exclusion criteria (2 listed)
- Patients with corrected visual Acuity >20/50 using a Rosenbaum Pocket Vision Screener, or
- Patients with a diagnosis of significant dementia, psychosis, or blindness.
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 |
|---|---|---|
| Literacy/Numeracy oriented educational interventionComprehensive educational Intervention | Behavioural | Intervention Arm |
| Control GroupReceives comprehensive education that is not literacy/numeracy sensitive | Behavioural | Control |
Primary outcome
A1C
Time frame: 3 and 6 months
3 secondary outcomes
Patient self-management behaviors
Time frame: 3 and 6 months
Patient knowledge
Time frame: 6 months
Patient satisfaction
Time frame: 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 18 Feb 2008.
- Derived from this study: PubMed 19741187Cavanaugh K, Wallston KA, Gebretsadik T, Shintani A, Huizinga MM, Davis D, Gregory RP, Malone R, Pignone M, DeWalt D, Elasy TA, Rothman RL. Addressing literacy and numeracy to improve diabetes care: two randomized controlled trials. Diabetes Care. 2009 Dec;32(12):2149-55. doi: 10.2337/dc09-0563. Epub 2009 Sep 9.
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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.
Russell L Rothman, MD MPP principal investigator
Vanderbilt 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 Literacy/Numeracy oriented educational intervention in people with Diabetes, run by Vanderbilt 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 5 inclusion and 2 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 18 Feb 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.
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?
A1C (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?
On the ClinicalTrials.gov record for NCT00311922, which also lists 1 linked publication.
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 18 Feb 2008.