Diabetes Mellitus, Type 2NCT00022750
Randomized Trial of Health Events Costs in Diabetic Blacks
A study testing Nurse Case Manager and Community Health Worker Team in people with Diabetes Mellitus, Type 2, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Diabetes mellitus imposes a major burden on the public health of the United States, leading annually to over 300,000 deaths and over $130 billion in costs. This burden falls disproportionately upon ethnic minority groups, particularly African Americans, who are at excess risk for the development of type 2 diabetes and… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Nurse Case Manager and Community Health Worker Team
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2000to May 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- African American male or female aged 30 years or older diagnosed with type 2 diabetes mellitus
- Able to provide 2 contact persons outside his/her household with active, verified telephone numbers
Who cannot join
- Mentally incompetent to give informed consent
- Refuses to give informed consent
- Comorbid health condition likely to lead to death in next 24 months
Trial locations and contacts
1 site in 1 country.
United States1 site
The Johns Hopkins Medical Institutions
Baltimore, Maryland, 21205
About this study
Official title: Project Sugar 2: Health Events Costs in Diabetic Blacks
Diabetes mellitus imposes a major burden on the public health of the United States, leading annually to over 300,000 deaths and over $130 billion in costs. This burden falls disproportionately upon ethnic minority groups, particularly African Americans, who are at excess risk for the development of type 2 diabetes and for a variety of its most serious complications. Suboptimal health care - in terms of access, quality, and adherence -appears to be an important contributing factor. Prior work suggests two possible approaches aimed at prevention to enhance risk factor control in outpatients with type 2 diabetes. One approach uses Nurse Case Managers (NCMs) to coordinate care plans with the provider team following protocols/clinical guidelines and algorithms designed to guide treatment including initiating and adjusting drug therapy, enhancing continuity of care, promoting interventions and self-management which include educational and behavioral strategies incorporating feedback and self-regulation. Another approach uses Community Health Workers (CHWs) to enhance culturally sensitive outreach, linkage, and monitoring service; to provide important patient and family education; and to improve access to and continuity of care. Results indicate that this intensive team approach, compared to usual care alone, produces substantial improvements in metabolic control. However, the cost-effectiveness of such interventions is unknown in the ''real-world''.
This has led to our current study, a randomized controlled trial within a managed care organization to determine the effects of a NCM/CHW team on metabolic control, on the occurrence of diabetes-related health events, health care utilization, and on direct health care costs. The participants will be African American adults with type 2 diabetes who receive primary care within a managed care organization in inner-city Baltimore.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Nurse Case Manager and Community Health Worker Team
- Keywords
- Type 2 Diabetes Mellitus, Nurse Case Manager, Community Health Worker, Behavioral Interventions, Cost-effectiveness, Randomized trial
- 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.
Nurse Case Manager and Community Health Worker TeamBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2001 (estimated)
- Study startOct 2000
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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
- Prevention
- Allocation
- Randomised
- Enrolment
- 800 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Frederick L. Brancati, MD, MHS, Principal investigator, The Johns Hopkins Medical Institutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00022750
- Sponsor's protocol ID
- DK48117 (completed)
- Other IDs
- R01DK048117-06, OPD-GCRC R00052
- Status last verified
- Jan 2010
- First submitted
- 10 Aug 2001
- Last updated
- 15 Jan 2010
- Results posted
- No
Publications
Brancati FL, Whittle JC, Whelton PK, Seidler AJ, Klag MJ. The excess incidence of diabetic end-stage renal disease among blacks. A population-based study of potential explanatory factors. JAMA. 1992 Dec 2;268(21):3079-84.
PubMed 1433738Brancati FL, Appel LJ, Seidler AJ, Whelton PK. Effect of potassium supplementation on blood pressure in African Americans on a low-potassium diet. A randomized, double-blind, placebo-controlled trial. Arch Intern Med. 1996 Jan 8;156(1):61-7.
PubMed 8526698Krop JS, Coresh J, Chambless LE, Shahar E, Watson RL, Szklo M, Brancati FL. A community-based study of explanatory factors for the excess risk for early renal function decline in blacks vs whites with diabetes: the Atherosclerosis Risk in Communities study. Arch Intern Med. 1999 Aug 9-23;159(15):1777-83. doi: 10.1001/archinte.159.15.1777.
PubMed 10448782Hill MN, Becker DM. Roles of nurses and health workers in cardiovascular health promotion. Am J Med Sci. 1995 Dec;310 Suppl 1:S123-6. doi: 10.1097/00000441-199512000-00022.
PubMed 7503115Shediac-Rizkallah MC, Bone LR. Planning for the sustainability of community-based health programs: conceptual frameworks and future directions for research, practice and policy. Health Educ Res. 1998 Mar;13(1):87-108. doi: 10.1093/her/13.1.87.
PubMed 10178339Levine DM, Becker DM, Bone LR, Hill MN, Tuggle MB 2nd, Zeger SL. Community-academic health center partnerships for underserved minority populations. One solution to a national crisis. JAMA. 1994 Jul 27;272(4):309-11. No abstract available.
PubMed 8028145Krop JS, Powe NR, Weller WE, Shaffer TJ, Saudek CD, Anderson GF. Patterns of expenditures and use of services among older adults with diabetes. Implications for the transition to capitated managed care. Diabetes Care. 1998 May;21(5):747-52. doi: 10.2337/diacare.21.5.747.
PubMed 9589235Powe NR, Weiner JP, Starfield B, Stuart M, Baker A, Steinwachs DM. Systemwide provider performance in a Medicaid program. Profiling the care of patients with chronic illnesses. Med Care. 1996 Aug;34(8):798-810. doi: 10.1097/00005650-199608000-00007.
PubMed 8709661Hill-Briggs F, Gary TL, Yeh HC, Batts-Turner M, Powe NR, Saudek CD, Brancati FL. Association of social problem solving with glycemic control in a sample of urban African Americans with type 2 diabetes. J Behav Med. 2006 Feb;29(1):69-78. doi: 10.1007/s10865-005-9037-0. Epub 2006 Jan 6.
PubMed 16397820Jackson CL, Bolen S, Brancati FL, Batts-Turner ML, Gary TL. A systematic review of interactive computer-assisted technology in diabetes care. Interactive information technology in diabetes care. J Gen Intern Med. 2006 Feb;21(2):105-10. doi: 10.1111/j.1525-1497.2005.00310.x. Epub 2005 Dec 22.
PubMed 16390512Gary TL, Maiese EM, Batts-Turner M, Wang NY, Brancati FL. Patient satisfaction, preventive services, and emergency room use among African-Americans with type 2 diabetes. Dis Manag. 2005 Dec;8(6):361-71. doi: 10.1089/dis.2005.8.361.
PubMed 16351554Gary TL, Hill-Briggs F, Batts-Turner M, Brancati FL. Translational research principles of an effectiveness trial for diabetes care in an urban African American population. Diabetes Educ. 2005 Nov-Dec;31(6):880-9. doi: 10.1177/0145721705282254.
PubMed 16288095Jackson CL, Batts-Turner ML, Falb MD, Yeh HC, Brancati FL, Gary TL. Computer and internet use among urban African Americans with type 2 diabetes. J Urban Health. 2005 Dec;82(4):575-83. doi: 10.1093/jurban/jti126. Epub 2005 Oct 12.
PubMed 16221917Gary TL, Batts-Turner M, Bone LR, Yeh HC, Wang NY, Hill-Briggs F, Levine DM, Powe NR, Hill MN, Saudek C, McGuire M, Brancati FL. A randomized controlled trial of the effects of nurse case manager and community health worker team interventions in urban African-Americans with type 2 diabetes. Control Clin Trials. 2004 Feb;25(1):53-66. doi: 10.1016/j.cct.2003.10.010.
PubMed 14980748Gary TL, Batts-Turner M, Yeh HC, Hill-Briggs F, Bone LR, Wang NY, Levine DM, Powe NR, Saudek CD, Hill MN, McGuire M, Brancati FL. The effects of a nurse case manager and a community health worker team on diabetic control, emergency department visits, and hospitalizations among urban African Americans with type 2 diabetes mellitus: a randomized controlled trial. Arch Intern Med. 2009 Oct 26;169(19):1788-94. doi: 10.1001/archinternmed.2009.338.
PubMed 19858437
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Sugar 2: Health Events Costs in Diabetic Blacks
- ClinicalTrials.gov ID
- NCT00022750
- Acronym / sponsor ID
- DK48117 (completed)
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Type 2 Diabetes Mellitus, Nurse Case Manager, Community Health Worker, Behavioral Interventions, Cost-effectiveness, Randomized trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Oct 2000
- Study completion
- May 2005
- First posted
- 10 Aug 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.
Diabetes mellitus imposes a major burden on the public health of the United States, leading annually to over 300,000 deaths and over $130 billion in costs. This burden falls disproportionately upon ethnic minority groups, particularly African Americans, who are at excess risk for the development of type 2 diabetes and for a variety of its most serious complications. Suboptimal health care - in terms of access, quality, and adherence -appears to be an important contributing factor. Prior work suggests two possible approaches aimed at prevention to enhance risk factor control in outpatients with type 2 diabetes. One approach uses Nurse Case Managers (NCMs) to coordinate care plans with the provider team following protocols/clinical guidelines and algorithms designed to guide treatment including initiating and adjusting drug therapy, enhancing continuity of care, promoting interventions and self-management which include educational and behavioral strategies incorporating feedback and self-regulation. Another approach uses Community Health Workers (CHWs) to enhance culturally sensitive outreach, linkage, and monitoring service; to provide important patient and family education; and to improve access to and continuity of care. Results indicate that this intensive team approach, compared to usual care alone, produces substantial improvements in metabolic control. However, the cost-effectiveness of such interventions is unknown in the ''real-world''.
This has led to our current study, a randomized controlled trial within a managed care organization to determine the effects of a NCM/CHW team on metabolic control, on the occurrence of diabetes-related health events, health care utilization, and on direct health care costs. The participants will be African American adults with type 2 diabetes who receive primary care within a managed care organization in inner-city Baltimore.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- African American male or female aged 30 years or older diagnosed with type 2 diabetes mellitus
- Able to provide 2 contact persons outside his/her household with active, verified telephone numbers
Key exclusion criteria (3 listed)
- Mentally incompetent to give informed consent
- Refuses to give informed consent
- Comorbid health condition likely to lead to death in next 24 months
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 |
|---|---|---|
| Nurse Case Manager and Community Health Worker Team | Behavioural | – |
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 15 Jan 2010.
- Background: PubMed 1433738Brancati FL, Whittle JC, Whelton PK, Seidler AJ, Klag MJ. The excess incidence of diabetic end-stage renal disease among blacks. A population-based study of potential explanatory factors. JAMA. 1992 Dec 2;268(21):3079-84.
- Background: PubMed 8526698Brancati FL, Appel LJ, Seidler AJ, Whelton PK. Effect of potassium supplementation on blood pressure in African Americans on a low-potassium diet. A randomized, double-blind, placebo-controlled trial. Arch Intern Med. 1996 Jan 8;156(1):61-7.
- Background: PubMed 10448782Krop JS, Coresh J, Chambless LE, Shahar E, Watson RL, Szklo M, Brancati FL. A community-based study of explanatory factors for the excess risk for early renal function decline in blacks vs whites with diabetes: the Atherosclerosis Risk in Communities study. Arch Intern Med. 1999 Aug 9-23;159(15):1777-83. doi: 10.1001/archinte.159.15.1777.
- Background: PubMed 7503115Hill MN, Becker DM. Roles of nurses and health workers in cardiovascular health promotion. Am J Med Sci. 1995 Dec;310 Suppl 1:S123-6. doi: 10.1097/00000441-199512000-00022.
- Background: PubMed 10178339Shediac-Rizkallah MC, Bone LR. Planning for the sustainability of community-based health programs: conceptual frameworks and future directions for research, practice and policy. Health Educ Res. 1998 Mar;13(1):87-108. doi: 10.1093/her/13.1.87.
- Background: PubMed 8028145Levine DM, Becker DM, Bone LR, Hill MN, Tuggle MB 2nd, Zeger SL. Community-academic health center partnerships for underserved minority populations. One solution to a national crisis. JAMA. 1994 Jul 27;272(4):309-11. No abstract available.
- Background: PubMed 9589235Krop JS, Powe NR, Weller WE, Shaffer TJ, Saudek CD, Anderson GF. Patterns of expenditures and use of services among older adults with diabetes. Implications for the transition to capitated managed care. Diabetes Care. 1998 May;21(5):747-52. doi: 10.2337/diacare.21.5.747.
- Background: PubMed 8709661Powe NR, Weiner JP, Starfield B, Stuart M, Baker A, Steinwachs DM. Systemwide provider performance in a Medicaid program. Profiling the care of patients with chronic illnesses. Med Care. 1996 Aug;34(8):798-810. doi: 10.1097/00005650-199608000-00007.
- Results publication: PubMed 16397820Hill-Briggs F, Gary TL, Yeh HC, Batts-Turner M, Powe NR, Saudek CD, Brancati FL. Association of social problem solving with glycemic control in a sample of urban African Americans with type 2 diabetes. J Behav Med. 2006 Feb;29(1):69-78. doi: 10.1007/s10865-005-9037-0. Epub 2006 Jan 6.
- Results publication: PubMed 16390512Jackson CL, Bolen S, Brancati FL, Batts-Turner ML, Gary TL. A systematic review of interactive computer-assisted technology in diabetes care. Interactive information technology in diabetes care. J Gen Intern Med. 2006 Feb;21(2):105-10. doi: 10.1111/j.1525-1497.2005.00310.x. Epub 2005 Dec 22.
- Results publication: PubMed 16351554Gary TL, Maiese EM, Batts-Turner M, Wang NY, Brancati FL. Patient satisfaction, preventive services, and emergency room use among African-Americans with type 2 diabetes. Dis Manag. 2005 Dec;8(6):361-71. doi: 10.1089/dis.2005.8.361.
- Results publication: PubMed 16288095Gary TL, Hill-Briggs F, Batts-Turner M, Brancati FL. Translational research principles of an effectiveness trial for diabetes care in an urban African American population. Diabetes Educ. 2005 Nov-Dec;31(6):880-9. doi: 10.1177/0145721705282254.
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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.
Frederick L. Brancati, MD, MHS principal investigator
The Johns Hopkins Medical Institutions
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse Case Manager and Community Health Worker Team in people with Diabetes Mellitus, Type 2, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 2 inclusion and 3 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 15 Jan 2010. 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 NCT00022750, which also lists 15 linked publications.
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 15 Jan 2010.