DiabetesNCT00822471
Feasibility and Impact of "ABCs of Diabetes" Self-Management Education Program at an Urban Public Library
A study testing Diabetes Self-Management Education in people with Diabetes and Cardiovascular Disease, run by Medstar Health Research Institute at 1 site in United States.
Trial summary
A concise diabetes self-management education (DSME) program on the "ABCs of Diabetes" will be placed in an urban public library to assess the feasibility of using this community setting for the delivery of health care education in an urban African American population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Cardiovascular Disease
- What is being tested?
- Diabetes Self-Management Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to Jul 2005
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Diabetes Mellitus, type 1 or type 2 for at least one month prior to taking the first educational class.
- 18 years old or older.
- Females and Males
- All ethnic groups.
- Must be able to read and speak English.
- Must be willing to sign informed consent to participate in the research component of the program.
Show all 13Show fewer
- Plan on living in the District of Columbia for the next 6 to 8 months.
- Willing to attend 2 core interactive education sessions within a 6-week period.
- Willing to have a fingerstick performed to obtain blood for A1C and cholesterol determinations prior to and 6 months after completion of the educational sessions.
- Willing to attend both a pre- and a post-study outcomes data collection visit, each of which will last approximately 1 - 1 ½ hours.
- Ability and willingness to adhere to all study requirements.
- Participant must have active health insurance coverage or self pay and have regular visits to their primary care physician. Interested parties who do not have health insurance will be referred to DHHS for assistance in applying for Medicare or Medicaid when applicable.
- Have access to telephone in residence to receive reminder calls for up upcoming visits.
Who cannot join
- Pregnancy.
- Non-English speaking.
- Untreated mental illness.
- History of substance abuse or alcohol abuse in the past 12 months.
- Individuals participating in a drug research study.
- Presence of concomitant condition or circumstances which, in the opinion of the investigator, could interfere with participation in the study, glycemic control or interpretation of the data collected. (e.g. active malignance; HIV/AIDS)
- Chronic concomitant use of oral steroids.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Feasibility and Impact of of "ABC's of Diabetes" Self Management Education (DSME) Program for African Americans at an Urban Public Library on A1C, Lipid Lowering Agent Prescriptions and Emergency Department Visits
A concise diabetes self-management education (DSME) program on the "ABCs of Diabetes" will be placed in an urban public library to assess the feasibility of using this community setting for the delivery of health care education in an urban African American population. Impact on knowledge of, prescriptions for, and control of blood sugar (A1C), blood pressure (BP) and LDL cholesterol (LDL-C)before and after participation in the program will be assessed. We will also examine the frequency of emergency department (ED) visits and hospitalizations for uncontrolled diabetes at 6 months post-DSME intervention.
Read the detailed description
A free, community-based Diabetes Learning Center was placed in a public library. Adults with diabetes (N=360) consented to participate in this prospective cohort study with historic self-controls. The small group, interactive DSME (two 2-1/2 hour classes) focused on improving CVD risk factors and enabling communication with the primary care physician. Knowledge, prescriptions, diabetes-related testing and clinical outcomes were assessed.
"ABCs of Diabetes" DSME Program
Class #1: A1C, Aspirin \& Blood Pressure
- Curriculum Content Areas:
- What is diabetes?
- A1C and blood glucose targets
- Diabetes medications
- Hypoglycemia
- Managing Blood Pressure
- Taking your medications
- Preventing vascular complications
- Monitoring your diabetes health
- "How to Talk to your Doctor"
- Education strategies \& tools
- Role playing from "How To Talk to Your Doctor"
- Ask for test results and how to get to targets
- Prompts to schedule appointments for ADA recommended exams, tests and discuss diabetes with primary care provider
Class #2 Cholesterol and Meal Planning
- Curriculum Content Areas:
- Managing cholesterol
- Diet, exercise \& weight management
- Cholesterol medications
- Smoking cessation
- Family Meal Planning: consistent carbohydrate
- heart healthy meals
- Education strategies \& tools
- View "Cut the Fat Back" video†
- Interactive portion size \& meal planning strategies
- Prompts to query PCP for LDL-C results;
- Flyers with questions to focus PCP on ADA goals † Produced by the Health Promotion Council, Philadelphia PA hpcpa@phmc.org
- Conditions
- Diabetes, Cardiovascular Disease
- Being tested
- Diabetes Self-Management Education
- Keywords
- Diabetes, Self-Management Education, Library, Emergency Department Visits, African American, CVD prevention, Prevention, Uncontrolled diabetes
- Medical subject headings
- Diabetes Mellitus, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Self-Management EducationBehavioural
DSME intervention consisting of two interactive 2-1/2 hour classes taught by a diabetes educator focusing on the "ABCs of diabetes" and training in how to talk to your doctor.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes Self-Management Education | Other | Education intervention with historic self-controls. Receives: Behavioral: Diabetes Self-Management Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in the percent of subjects correctly identifying guideline-recommended treatment targets for the "ABC's of Diabetes", where A = A1C < 7%; B = BP <130/80mmHg and; and C = LDL-C < 100mg/dl.
Measured: 6 months following program completion
Secondary outcomes (4)
increase the percentage of subjects taking medications for A1C, BP and LDL-C management and aspirin;
Measured: 6 months following DSME program completion
increase scores on the diabetes self-efficacy scale (DES);
Measured: 6 months following DSME program completion
increase percentage of patients with A1C, BP and LDL-C at recommended targets;
Measured: 6 months following program completion
Decrease the percentage of participants with self-reported ED visits and hospitalizations for severe hypoglycemia and hyperglycemia.
Measured: 6 months following DSME program completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2009 (estimated)
- Study startJan 2003
- Primary completionJan 2005
- Study completionJul 2005
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Medstar Diabetes Institute;, American Diabetes Association, Bayer, CareFirst BlueCross Blue Shield;, District of Columbia, Department of Health Block Grants Program;, Charles and Mary Latham Trust Fund;, Eli Lilly and Company, Hewlett-Packard, Meltzer Entities;, NBC Washington, Novo Nordisk A/S, Aventis Pharmaceuticals, Takeda Pharmaceuticals North America, Inc., Pfizer
- Responsible party
- Principal investigator, Michelle Magee, Medstar Health Research Institute
- Investigators
- Michelle F. Magee, MD, LRCPSI, Principal investigator, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00822471
- Sponsor's protocol ID
- 2002-288
- Status last verified
- Aug 2020
- First submitted
- 12 Jan 2009
- Last updated
- 25 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Impact of of "ABC's of Diabetes" Self Management Education (DSME) Program for African Americans at an Urban Public Library on A1C, Lipid Lowering Agent Prescriptions and Emergency Department Visits
- ClinicalTrials.gov ID
- NCT00822471
- Acronym / sponsor ID
- 2002-288
- Conditions
- Diabetes, Cardiovascular Disease
- Keywords
- Diabetes, Self-Management Education, Library, Emergency Department Visits, African American, CVD prevention, Prevention, Uncontrolled diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Collaborators
- Medstar Diabetes Institute;, American Diabetes Association, Bayer, CareFirst BlueCross Blue Shield;, District of Columbia, Department of Health Block Grants Program;, Charles and Mary Latham Trust Fund;, Eli Lilly and Company, Hewlett-Packard, Meltzer Entities;, NBC Washington, Novo Nordisk A/S, Aventis Pharmaceuticals, Takeda Pharmaceuticals North America, Inc., Pfizer
- Study start
- Jan 2003
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 14 Jan 2009 (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.
A concise diabetes self-management education (DSME) program on the "ABCs of Diabetes" will be placed in an urban public library to assess the feasibility of using this community setting for the delivery of health care education in an urban African American population. Impact on knowledge of, prescriptions for, and control of blood sugar (A1C), blood pressure (BP) and LDL cholesterol (LDL-C)before and after participation in the program will be assessed. We will also examine the frequency of emergency department (ED) visits and hospitalizations for uncontrolled diabetes at 6 months post-DSME intervention.
Detailed description
A free, community-based Diabetes Learning Center was placed in a public library. Adults with diabetes (N=360) consented to participate in this prospective cohort study with historic self-controls. The small group, interactive DSME (two 2-1/2 hour classes) focused on improving CVD risk factors and enabling communication with the primary care physician. Knowledge, prescriptions, diabetes-related testing and clinical outcomes were assessed.
"ABCs of Diabetes" DSME Program
Class #1: A1C, Aspirin \& Blood Pressure
- Curriculum Content Areas:
- What is diabetes?
- A1C and blood glucose targets
- Diabetes medications
- Hypoglycemia
- Managing Blood Pressure
- Taking your medications
- Preventing vascular complications
- Monitoring your diabetes health
- "How to Talk to your Doctor"
- Education strategies \& tools
- Role playing from "How To Talk to Your Doctor"
- Ask for test results and how to get to targets
- Prompts to schedule appointments for ADA recommended exams, tests and discuss diabetes with primary care provider
Class #2 Cholesterol and Meal Planning
- Curriculum Content Areas:
- Managing cholesterol
- Diet, exercise \& weight management
- Cholesterol medications
- Smoking cessation
- Family Meal Planning: consistent carbohydrate
- heart healthy meals
- Education strategies \& tools
- View "Cut the Fat Back" video†
- Interactive portion size \& meal planning strategies
- Prompts to query PCP for LDL-C results;
- Flyers with questions to focus PCP on ADA goals † Produced by the Health Promotion Council, Philadelphia PA hpcpa@phmc.org
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetes Self-Management Education | Other | Behavioral: Diabetes Self-Management EducationEducation intervention with historic self-controls. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Diagnosis of Diabetes Mellitus, type 1 or type 2 for at least one month prior to taking the first educational class.
- 18 years old or older.
- Females and Males
- All ethnic groups.
- Must be able to read and speak English.
Key exclusion criteria (7 listed)
- Pregnancy.
- Non-English speaking.
- Untreated mental illness.
- History of substance abuse or alcohol abuse in the past 12 months.
- Individuals participating in a drug research study.
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 |
|---|---|---|
| Diabetes Self-Management EducationDSME intervention consisting of two interactive 2-1/2 hour classes taught by a diabetes educator focusing on the "ABCs of diabetes" and training in how to talk to your doctor. | Behavioural | Diabetes Self-Management Education |
Primary outcome
Improvement in the percent of subjects correctly identifying guideline-recommended treatment targets for the "ABC's of Diabetes", where A = A1C < 7%; B = BP <130/80mmHg and; and C = LDL-C < 100mg/dl.
Time frame: 6 months following program completion
4 secondary outcomes
increase the percentage of subjects taking medications for A1C, BP and LDL-C management and aspirin;
Time frame: 6 months following DSME program completion
increase scores on the diabetes self-efficacy scale (DES);
Time frame: 6 months following DSME program completion
increase percentage of patients with A1C, BP and LDL-C at recommended targets;
Time frame: 6 months following program completion
Decrease the percentage of participants with self-reported ED visits and hospitalizations for severe hypoglycemia and hyperglycemia.
Time frame: 6 months following DSME program completion
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 25 Aug 2020.
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Michelle F. Magee, MD, LRCPSI principal investigator
Medstar Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Self-Management Education in people with Diabetes and Cardiovascular Disease, run by Medstar Health Research Institute 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 13 inclusion and 7 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 25 Aug 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?
Improvement in the percent of subjects correctly identifying guideline-recommended treatment targets for the "ABC's of Diabetes", where A = A1C < 7%; B = BP <130/80mmHg and; and C = LDL-C < 100mg/dl. (time frame: 6 months following program completion). 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 25 Aug 2020.