Diabetes Mellitus Self Management EducationNCT00012662
Disease Management and Educational Intervention Outcomes in High-Risk Diabetics
A study testing Diabetes Self Management Education in people with Diabetes Mellitus Self Management Education and Hyperglycemic Control, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
Social, medical and economic burdens of diabetes care result from microvascular, macrovascular and neurological complications. Sustained reduction in hyperglycemia can reduce the incidence of these complications by as much as 50 percent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus Self Management Education, Hyperglycemic Control, High Risk Diabetes
- 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
- 1,800 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Dec 2002
- 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
- Type 2 diabetes HbA1C. 9.0%, consistent diabetes tx over last 3 months.
Who cannot join
- Homelessness-not able to be consistently contacted; Dementia, Planned Movement from area; Unstable angina, Myocardial Infarction in past 3 months; Stroke; Two or more seizures in last 3 months; document alcoholism or drug abuse; Pregnant or planning to become pregnant in next 12 months; Severe immunodeficiency or cirrhosis of the liver; Type 1 diabetes; blind individuals; psychosis; pancreatitis with secondary diabetes; Renal disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Atlanta, Kansas, 21201
About this study
Social, medical and economic burdens of diabetes care result from microvascular, macrovascular and neurological complications. Sustained reduction in hyperglycemia can reduce the incidence of these complications by as much as 50 percent. Studies have demonstrated improved glycemic control with nurse case-management or educational care models. However, none have controlled for their independent contributions, intervened with advanced practice nurses (APN), or targeted highest risk individuals.
Read the detailed description
Background:
Social, medical and economic burdens of diabetes care result from microvascular, macrovascular and neurological complications. Sustained reduction in hyperglycemia can reduce the incidence of these complications by as much as 50 percent. Studies have demonstrated improved glycemic control with nurse case-management or educational care models. However, none have controlled for their independent contributions, intervened with advanced practice nurses (APN), or targeted highest risk individuals.
Objectives:
The objective of this project is to examine whether interventions of diabetes self-management education programs with or without APN case managers improve outcomes and are cost effective.
Methods:
Patients were randomly assigned to one of four groups: 1) Disease-management and diabetes education; 2) Disease-management alone; 3) Diabetes education alone; and 4) Routine Care. Veterans receiving primary care in VISN-5 and meeting high-risk criteria (HbA1c � 9.0%) were screened for inclusion. Patient outcome measures were collected at baseline, three months and twelve months. These included: Quality of Life (QOL), HgbAlc levels, and incidence of diabetes-related hospitalizations/ER visits. In addition, patient-level intervention costs, health care use and costs were examined. ANOVA comparisons were used to test hypotheses.
Status:
Recruitment is over and final analyses are underway.
- Being tested
- Diabetes Self Management Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Self Management EducationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Behavioral: Diabetes Self Management Education |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2001 (estimated)
- Study completionDec 2002
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 Diabetes Mellitus Self Management EducationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Bruce P. Hamilton, MD, Principal investigator, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00012662
- Sponsor's protocol ID
- DII 99-188
- Status last verified
- Feb 2007
- First submitted
- 14 Mar 2001
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Bradham DD, Mangan M, Warrick A, Geiger-Brown J, Reiner JI, Saunders HJ. Linking innovative nursing practice to health services research. Nurs Clin North Am. 2000 Jun;35(2):557-68.
PubMed 10873268
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disease Management and Educational Intervention Outcomes in High-Risk Diabetics
- ClinicalTrials.gov ID
- NCT00012662
- Acronym / sponsor ID
- DII 99-188
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study completion
- Dec 2002 (actual)
- First posted
- 16 Mar 2001 (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.
Social, medical and economic burdens of diabetes care result from microvascular, macrovascular and neurological complications. Sustained reduction in hyperglycemia can reduce the incidence of these complications by as much as 50 percent. Studies have demonstrated improved glycemic control with nurse case-management or educational care models. However, none have controlled for their independent contributions, intervened with advanced practice nurses (APN), or targeted highest risk individuals.
Detailed description
Background:
Social, medical and economic burdens of diabetes care result from microvascular, macrovascular and neurological complications. Sustained reduction in hyperglycemia can reduce the incidence of these complications by as much as 50 percent. Studies have demonstrated improved glycemic control with nurse case-management or educational care models. However, none have controlled for their independent contributions, intervened with advanced practice nurses (APN), or targeted highest risk individuals.
Objectives:
The objective of this project is to examine whether interventions of diabetes self-management education programs with or without APN case managers improve outcomes and are cost effective.
Methods:
Patients were randomly assigned to one of four groups: 1) Disease-management and diabetes education; 2) Disease-management alone; 3) Diabetes education alone; and 4) Routine Care. Veterans receiving primary care in VISN-5 and meeting high-risk criteria (HbA1c � 9.0%) were screened for inclusion. Patient outcome measures were collected at baseline, three months and twelve months. These included: Quality of Life (QOL), HgbAlc levels, and incidence of diabetes-related hospitalizations/ER visits. In addition, patient-level intervention costs, health care use and costs were examined. ANOVA comparisons were used to test hypotheses.
Status:
Recruitment is over and final analyses are underway.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Behavioral: Diabetes Self Management Education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Type 2 diabetes HbA1C. 9.0%, consistent diabetes tx over last 3 months.
Key exclusion criteria (1 listed)
- Homelessness-not able to be consistently contacted; Dementia, Planned Movement from area; Unstable angina, Myocardial Infarction in past 3 months; Stroke; Two or more seizures in last 3 months; document alcoholism or drug abuse; Pregnant or planning to become pregnant in next 12 months; Severe immunodeficiency or cirrhosis of the liver; Type 1 diabetes; blind individuals; psychosis; pancreatitis with secondary diabetes; Renal disease.
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 Education | Behavioural | Arm 1 |
Primary outcome
Not reported in the source record.
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 7 Apr 2015.
- Results publication: PubMed 10873268Bradham DD, Mangan M, Warrick A, Geiger-Brown J, Reiner JI, Saunders HJ. Linking innovative nursing practice to health services research. Nurs Clin North Am. 2000 Jun;35(2):557-68.
Related trials for Diabetes Mellitus Self Management Education
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Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
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A Novel Miniature Equine-Assisted Diabetes Education Program for Youth: Evaluating the Diabetes Equine Empowerment Program (DEEP).
Diabetes (Insulin-requiring, Type 1 or Type 2), Pediatric Diabetes
Active, not recruiting
Empowering Faith-based Communities to Provide Personalized Diabetes Self-management Education and Support (DSMES) in the Magic City
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Support-t Online Training in Youth Living With Type 1 Diabetes Transitioning to Adult Care
Diabetes Mellitus, Diabetes Mellitus, Type 1
Not yet recruiting
Effect of Interactive Video-Based Self-Management Education in Adults With Type 2 Diabetes
Type 2 Diabetes, Outpatient
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.
Bruce P. Hamilton, MD principal investigator
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
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 Mellitus Self Management Education and Hyperglycemic Control, run by US Department of Veterans Affairs 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 7 Apr 2015. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00012662, 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 7 Apr 2015.