Type 2 DiabetesNCT01339520
Diabetes Scorecard Educational Intervention Study
A study testing Scorecard in people with Type 2 Diabetes, run by George Washington University at 1 site in United States.
Trial summary
The purpose of this study is to see if the use of a diabetic scorecard during clinic visits can improve glycemic control, blood pressure control, LDL-cholesterol, aspirin usage, and amount of exercise in adults over age 40 with uncontrolled Type II diabetes. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Scorecard
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to May 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Uncontrolled Type II diabetes (HbA1c ≥ 8%)
Who cannot join
- Type I Diabetes
- HbA1c < 8%
- Inability to understand the diabetes scorecard due to condition (i.e. dementia, mental retardation, etc) or language barrier
- Pregnancy
- Planning to move within the next year
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical Faculty Associates, George Washington University
Washington D.C., District of Columbia, 20037
About this study
Official title: Use of a Card to Improve Risk Factor Control in Patients With Type II Diabetes
The purpose of this study is to see if the use of a diabetic scorecard during clinic visits can improve glycemic control, blood pressure control, LDL-cholesterol, aspirin usage, and amount of exercise in adults over age 40 with uncontrolled Type II diabetes.
- Conditions
- Type 2 Diabetes
- Being tested
- Scorecard, Control
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScorecardBehavioural
Points were assigned for blood pressure, HbA1c level, LDL-cholesterol level, aspirin use and exercise level.
ControlBehavioural
Standard of care for diabetes subjects
| Study group | Role | What they receive |
|---|---|---|
| Scorecard | Experimental | Score of points for variables. Receives: Behavioral: Scorecard; Behavioral: Control |
| Control | No intervention | Standard of care for diabetes subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total score
The total score was calculated by points assigned to variables (systolic blood pressure, diastolic blood pressure, HbA1c, aspirin usage and daily exercise). The maximal score of 100 corresponds to all variables at target. Fewer points were assigned to higher blood pressure, worse HbA1c levels, less exercise, etc.
Measured: 9 months
Secondary outcomes (2)
LDL-cholesterol
Measured: 9 months
HbA1c
Measure of glycemic control
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2011 (estimated)
- Study startNov 2008
- Primary completionMay 2010
- Study completionMay 2010
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 Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by George Washington 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Irwig, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01339520
- Sponsor's protocol ID
- DiabetesScorecardStudy
- Status last verified
- Aug 2017
- First submitted
- 19 Apr 2011
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Irwig MS, Sood P, Ni D, Amass T, Khurana PS, Jayanthi VV, Wang L, Adler SM. A diabetes scorecard does not improve HbA(1c), blood pressure, lipids, aspirin usage, exercise and diabetes knowledge over 9 months: a randomized controlled trial. Diabet Med. 2012 Sep;29(9):1206-12. doi: 10.1111/j.1464-5491.2012.03610.x.
PubMed 22332914
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Card to Improve Risk Factor Control in Patients With Type II Diabetes
- ClinicalTrials.gov ID
- NCT01339520
- Acronym / sponsor ID
- DiabetesScorecardStudy
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 20 Apr 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.
The purpose of this study is to see if the use of a diabetic scorecard during clinic visits can improve glycemic control, blood pressure control, LDL-cholesterol, aspirin usage, and amount of exercise in adults over age 40 with uncontrolled Type II diabetes.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scorecard | Experimental | Behavioral: Scorecard, Behavioral: ControlScore of points for variables. |
| Control | No intervention | –Standard of care for diabetes subjects |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Uncontrolled Type II diabetes (HbA1c ≥ 8%)
Key exclusion criteria (5 listed)
- Type I Diabetes
- HbA1c < 8%
- Inability to understand the diabetes scorecard due to condition (i.e. dementia, mental retardation, etc) or language barrier
- Pregnancy
- Planning to move within the next year
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 |
|---|---|---|
| ScorecardPoints were assigned for blood pressure, HbA1c level, LDL-cholesterol level, aspirin use and exercise level. | Behavioural | Scorecard |
| ControlStandard of care for diabetes subjects | Behavioural | Scorecard |
Primary outcome
Change in total score
Time frame: 9 months
The total score was calculated by points assigned to variables (systolic blood pressure, diastolic blood pressure, HbA1c, aspirin usage and daily exercise). The maximal score of 100 corresponds to all variables at target. Fewer points were assigned to higher blood pressure, worse HbA1c levels, less exercise, etc.
2 secondary outcomes
LDL-cholesterol
Time frame: 9 months
HbA1c
Time frame: 9 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 11 Aug 2017.
- Derived from this study: PubMed 22332914Irwig MS, Sood P, Ni D, Amass T, Khurana PS, Jayanthi VV, Wang L, Adler SM. A diabetes scorecard does not improve HbA(1c), blood pressure, lipids, aspirin usage, exercise and diabetes knowledge over 9 months: a randomized controlled trial. Diabet Med. 2012 Sep;29(9):1206-12. doi: 10.1111/j.1464-5491.2012.03610.x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scorecard in people with Type 2 Diabetes, run by George Washington 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 5 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 11 Aug 2017. 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?
Change in total score (time frame: 9 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 NCT01339520, 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 11 Aug 2017.