Type 2 Diabetes MellitusNCT00109720
Evaluation of Diabetes Self-Management Consultant Care
A study testing Diabetes Self-Management Consultant in people with Type 2 Diabetes Mellitus, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 2 sites in United States.
Trial summary
The purpose of this study is to find out if Self-Management Consultant (SMC) intervention will be more effective than usual care in improving blood glucose control and diabetes-related quality of life for adults with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Diabetes Self-Management Consultant
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2002to Jul 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults over age 21 diagnosed with type 2 diabetes for at least one year.
Who cannot join
- Patients under psychiatric care
- Currently pregnant
- Those who have not been diagnosed with type 2 diabetes
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan, Department of Family Medicine Clinics
Ann Arbor, Michigan, 48109
Detroit Health Department
Detroit, Michigan, 48202
About this study
The purpose of this study is to find out if Self-Management Consultant (SMC) intervention will be more effective than usual care in improving blood glucose control and diabetes-related quality of life for adults with type 2 diabetes.
Read the detailed description
This study is designed to compare the effectiveness of a diabetes Self-Management Consultant (SMC) intervention for adults with type 2 diabetes with unsatisfactory glucose control (i.e., HbA1c ≥ 8%--the value chosen as "high risk" by the Diabetes Quality Improvement Project which is an initiative of the Health Care Financing Administration, the American Diabetes Association, and the Foundation for Accountability) to a control group selected using the same criteria. The SMC intervention will be implemented and evaluated in two different health care systems serving two distinct populations of patients with diabetes. After signing the Informed Consent document, subjects will be randomized to the SMC intervention or a control group. All subjects in the study will complete a baseline assessment of their diabetes care and health status.
Subjects randomized to the SMC intervention will have an individual meeting with the SMC to review and refine a self-management plan based on the subject's priorities and goals. These subjects will receive individual follow-up and support during the year, through monthly phone calls and an annual meeting with the SMC and their primary care physician. Subjects randomized to the control group will receive usual care following their baseline and their 12-, 24-, and 36-month assessments. Unlike most nurse-manager studies, the SMC's interactions with patient care will use a theory-based behavioral approach with which we have extensive experience. The study is designed to evaluate the effectiveness of the SMC intervention compared to usual care.
All records will be handled confidentially. Lab results and personal data will be linked by a research specific identifier code.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Diabetes Self-Management Consultant, Enhanced Usual Care Control Group
- Keywords
- Diabetes, Self Management, Type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Self-Management ConsultantBehavioural
services of a Diabetes Self-Management Consultant
Enhanced Usual Care Control GroupBehavioural
Usual care plus results of metabolic assessments obtained during the study
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients in the experimental group received the services of a Diabetes Self-Management Consultant (DSC) Receives: Behavioral: Diabetes Self-Management Consultant |
| 2 | Active comparator | This Arm was a Enhanced Usual Care Control group who continued with their usual care but also they and their physicians received the results of all metabolic assessments obtained during the study. Receives: Behavioral: Enhanced Usual Care Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose level
Measured: two years
Secondary outcomes (1)
Diabetes Related Quality of life
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2005 (estimated)
- Study startAug 2002
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Detroit Department of Health
- Investigators
- Robert Anderson, Ed. D., Principal investigator, Department of Medical Education, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00109720
- Sponsor's protocol ID
- 62323 (completed)
- Status last verified
- Jan 2010
- First submitted
- 2 May 2005
- Last updated
- 15 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Heisler M, Vijan S, Anderson RM, Ubel PA, Bernstein SJ, Hofer TP. When do patients and their physicians agree on diabetes treatment goals and strategies, and what difference does it make? J Gen Intern Med. 2003 Nov;18(11):893-902. doi: 10.1046/j.1525-1497.2003.21132.x.
PubMed 14687274Funnell MM, Anderson RM. Changing office practice and health care systems to facilitate diabetes self-management. Curr Diab Rep. 2003 Apr;3(2):127-33. doi: 10.1007/s11892-003-0036-7.
PubMed 12728638Funnell MM, Anderson RM. Patient empowerment: a look back, a look ahead. Diabetes Educ. 2003 May-Jun;29(3):454-8, 460, 462 passim. doi: 10.1177/014572170302900310. No abstract available.
PubMed 12854337Anderson RM, Fitzgerald JT, Gruppen LD, Funnell MM, Oh MS. The Diabetes Empowerment Scale-Short Form (DES-SF). Diabetes Care. 2003 May;26(5):1641-2. doi: 10.2337/diacare.26.5.1641-a. No abstract available.
PubMed 12716841Funnell MM, Anderson RM. Working toward the next generation of diabetes self-management education. Am J Prev Med. 2002 May;22(4 Suppl):3-5. doi: 10.1016/s0749-3797(02)00431-2. No abstract available.
PubMed 11985929Anderson RM, Funnell MM. Compliance and adherence are dysfunctional concepts in diabetes care. Diabetes Educ. 2000 Jul-Aug;26(4):597-604. doi: 10.1177/014572170002600405.
PubMed 11140071
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
- Evaluation of Diabetes Self-Management Consultant Care
- ClinicalTrials.gov ID
- NCT00109720
- Acronym / sponsor ID
- 62323 (completed)
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Diabetes, Self Management, Type 2 diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Collaborators
- Detroit Department of Health
- Study start
- Aug 2002
- Study completion
- Jul 2007 (actual)
- First posted
- 3 May 2005 (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 find out if Self-Management Consultant (SMC) intervention will be more effective than usual care in improving blood glucose control and diabetes-related quality of life for adults with type 2 diabetes.
Detailed description
This study is designed to compare the effectiveness of a diabetes Self-Management Consultant (SMC) intervention for adults with type 2 diabetes with unsatisfactory glucose control (i.e., HbA1c ≥ 8%--the value chosen as "high risk" by the Diabetes Quality Improvement Project which is an initiative of the Health Care Financing Administration, the American Diabetes Association, and the Foundation for Accountability) to a control group selected using the same criteria. The SMC intervention will be implemented and evaluated in two different health care systems serving two distinct populations of patients with diabetes. After signing the Informed Consent document, subjects will be randomized to the SMC intervention or a control group. All subjects in the study will complete a baseline assessment of their diabetes care and health status.
Subjects randomized to the SMC intervention will have an individual meeting with the SMC to review and refine a self-management plan based on the subject's priorities and goals. These subjects will receive individual follow-up and support during the year, through monthly phone calls and an annual meeting with the SMC and their primary care physician. Subjects randomized to the control group will receive usual care following their baseline and their 12-, 24-, and 36-month assessments. Unlike most nurse-manager studies, the SMC's interactions with patient care will use a theory-based behavioral approach with which we have extensive experience. The study is designed to evaluate the effectiveness of the SMC intervention compared to usual care.
All records will be handled confidentially. Lab results and personal data will be linked by a research specific identifier code.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Diabetes Self-Management ConsultantPatients in the experimental group received the services of a Diabetes Self-Management Consultant (DSC) |
| 2 | Active comparator | Behavioral: Enhanced Usual Care Control GroupThis Arm was a Enhanced Usual Care Control group who continued with their usual care but also they and their physicians received the results of all metabolic assessments obtained during the study. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults over age 21 diagnosed with type 2 diabetes for at least one year.
Key exclusion criteria (3 listed)
- Patients under psychiatric care
- Currently pregnant
- Those who have not been diagnosed with type 2 diabetes
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 Consultantservices of a Diabetes Self-Management Consultant | Behavioural | 1 |
| Enhanced Usual Care Control GroupUsual care plus results of metabolic assessments obtained during the study | Behavioural | 2 |
Primary outcome
Blood glucose level
Time frame: two years
1 secondary outcome
Diabetes Related Quality of life
Time frame: two years
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 14687274Heisler M, Vijan S, Anderson RM, Ubel PA, Bernstein SJ, Hofer TP. When do patients and their physicians agree on diabetes treatment goals and strategies, and what difference does it make? J Gen Intern Med. 2003 Nov;18(11):893-902. doi: 10.1046/j.1525-1497.2003.21132.x.
- Background: PubMed 12728638Funnell MM, Anderson RM. Changing office practice and health care systems to facilitate diabetes self-management. Curr Diab Rep. 2003 Apr;3(2):127-33. doi: 10.1007/s11892-003-0036-7.
- Background: PubMed 12854337Funnell MM, Anderson RM. Patient empowerment: a look back, a look ahead. Diabetes Educ. 2003 May-Jun;29(3):454-8, 460, 462 passim. doi: 10.1177/014572170302900310. No abstract available.
- Background: PubMed 12716841Anderson RM, Fitzgerald JT, Gruppen LD, Funnell MM, Oh MS. The Diabetes Empowerment Scale-Short Form (DES-SF). Diabetes Care. 2003 May;26(5):1641-2. doi: 10.2337/diacare.26.5.1641-a. No abstract available.
- Background: PubMed 11985929Funnell MM, Anderson RM. Working toward the next generation of diabetes self-management education. Am J Prev Med. 2002 May;22(4 Suppl):3-5. doi: 10.1016/s0749-3797(02)00431-2. No abstract available.
- Background: PubMed 11140071Anderson RM, Funnell MM. Compliance and adherence are dysfunctional concepts in diabetes care. Diabetes Educ. 2000 Jul-Aug;26(4):597-604. doi: 10.1177/014572170002600405.
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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.
Robert Anderson, Ed. D. principal investigator
Department of Medical Education, University of Michigan
2 sites 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 Consultant in people with Type 2 Diabetes Mellitus, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 2 sites 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 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 2 sites 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?
Blood glucose level (time frame: two years). 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 NCT00109720, which also lists 6 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.