DiabetesPhase 3NCT00291590
Diabetes Health Enhancement Program to Improve Health of People With Diabetes
A Phase 3 study testing DHEP in people with Diabetes, run by Robert Wood Johnson Foundation at 1 site in United States.
Trial summary
Management of chronic diseases, such as diabetes, relies upon the health care providers and the patients self-care. Self management programs for diabetes that target self-empowerment tools have been found to be effective in some studies, but have not typically included individuals on Medicaid. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Diabetes
- What is being tested?
- DHEP
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2001to Aug 2003
- Phase
- Phase 3
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Insured under Medicaid (SSI) or dual enrolled under Medicaid and Medicare for at least one year
- Diagnosed type 1 or type 2 diabetes for at least 1 year (>1 inpatient or >2 outpatients visits with ICD-9 codes 250.00-250.9x, or prescriptions for insulin and/or oral hyperglycemic medications)
- Aged 40-85 years
- Geographically close to the Southeast Senior Center in South King County, Washington, and have a primary care provider (not HMO).
Who cannot join
- Serious kidney disease (serum creatinine >2.5 or end-stage renal disease)
- Other serious illness that would preclude one-year study participation (dementia, terminal illness, organ transplantation)
- Pregnancy
- Inability to given informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Puget Sound Veterans Administration
Seattle, Washington, 98101
About this study
Official title: Phase 3 Randomized Controlled Trial of the Diabetes Health Enhancement Program for Medicaid and Dual Eligibles in South King County, Washington
Management of chronic diseases, such as diabetes, relies upon the health care providers and the patients self-care. Self management programs for diabetes that target self-empowerment tools have been found to be effective in some studies, but have not typically included individuals on Medicaid.
Our goal for this trial was to observe if patients participating in such a program could decrease glycated hemoglobin levels, improve health status and improve self-care practices.
Read the detailed description
Design, Setting and Population: A Phase 3, one year prospective trial, randomized to intervention or control (usual care) with Medicaid or dual-Medicare beneficiaries, with diabetes, aged 40-85 years old residing in South King County, Washington.
Intervention: A targeted, multi-component, self-management program incorporating a stage-of-change approach to overcome barriers and facilitate life-style behavior changes to achieve patient-driven health action plans for nutrition or exercise goals.
Main Outcome Measures: Glycemic control (HbA1c), physical and mental health, self-care practices.
Recruitment Status: Completed: participants are no longer being recruited; data analysis is complete.
- Conditions
- Diabetes
- Being tested
- DHEP
- Keywords
- diabetes, behavioral change, chronic care model, stage of change, Medicaid, Dual eligible, ethnic, self-care
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHEPBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in glycated hemoglobin levels
Secondary outcomes (1)
Improvement in health status and diabetes self-care practices
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2006 (estimated)
- Study startJul 2001
- Study completionAug 2003
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 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 3
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants
Sponsor and investigators
- Lead sponsor
- Robert Wood Johnson Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Aventis Pharmaceuticals
- Investigators
- Gayle E Reiber, PhD, Principal investigator, Puget Sound VA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00291590
- Sponsor's protocol ID
- DHEP001
- Status last verified
- Jun 2005
- First submitted
- 13 Feb 2006
- Last updated
- 14 Feb 2006
- Results posted
- No
Publications
McFarland LV, Reiber GE, Norman JE. Recruitment of Medicaid and dual-enrolled Medicare beneficiaries with diabetes mellitus into a randomized controlled trial. Am J Manag Care. 2005 Jul;11(7):443-8.
PubMed 16044981
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Randomized Controlled Trial of the Diabetes Health Enhancement Program for Medicaid and Dual Eligibles in South King County, Washington
- ClinicalTrials.gov ID
- NCT00291590
- Acronym / sponsor ID
- DHEP001
- Conditions
- Diabetes
- Keywords
- diabetes, behavioral change, chronic care model, stage of change, Medicaid, Dual eligible, ethnic, self-care
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants
- Lead sponsor
- Robert Wood Johnson FoundationUniversity, hospital or other
- Collaborators
- Aventis Pharmaceuticals
- Study start
- Jul 2001
- Study completion
- Aug 2003
- First posted
- 14 Feb 2006 (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.
Management of chronic diseases, such as diabetes, relies upon the health care providers and the patients self-care. Self management programs for diabetes that target self-empowerment tools have been found to be effective in some studies, but have not typically included individuals on Medicaid.
Our goal for this trial was to observe if patients participating in such a program could decrease glycated hemoglobin levels, improve health status and improve self-care practices.
Detailed description
Design, Setting and Population: A Phase 3, one year prospective trial, randomized to intervention or control (usual care) with Medicaid or dual-Medicare beneficiaries, with diabetes, aged 40-85 years old residing in South King County, Washington.
Intervention: A targeted, multi-component, self-management program incorporating a stage-of-change approach to overcome barriers and facilitate life-style behavior changes to achieve patient-driven health action plans for nutrition or exercise goals.
Main Outcome Measures: Glycemic control (HbA1c), physical and mental health, self-care practices.
Recruitment Status: Completed: participants are no longer being recruited; data analysis is complete.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Insured under Medicaid (SSI) or dual enrolled under Medicaid and Medicare for at least one year
- Diagnosed type 1 or type 2 diabetes for at least 1 year (>1 inpatient or >2 outpatients visits with ICD-9 codes 250.00-250.9x, or prescriptions for insulin and/or oral hyperglycemic medications)
- Aged 40-85 years
- Geographically close to the Southeast Senior Center in South King County, Washington, and have a primary care provider (not HMO).
Key exclusion criteria (4 listed)
- Serious kidney disease (serum creatinine >2.5 or end-stage renal disease)
- Other serious illness that would preclude one-year study participation (dementia, terminal illness, organ transplantation)
- Pregnancy
- Inability to given informed consent.
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 |
|---|---|---|
| DHEP | Behavioural | – |
Primary outcome
Reduction in glycated hemoglobin levels
1 secondary outcome
Improvement in health status and diabetes self-care practices
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 14 Feb 2006.
- Background: PubMed 16044981McFarland LV, Reiber GE, Norman JE. Recruitment of Medicaid and dual-enrolled Medicare beneficiaries with diabetes mellitus into a randomized controlled trial. Am J Manag Care. 2005 Jul;11(7):443-8.
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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.
Gayle E Reiber, PhD principal investigator
Puget Sound VA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DHEP in people with Diabetes, run by Robert Wood Johnson Foundation 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 4 inclusion and 4 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 14 Feb 2006. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Reduction in glycated hemoglobin levels. 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 NCT00291590, 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 14 Feb 2006.