DiabetesNCT00148304
Insulin Treatment Variation in Southwestern Diabetics
An observational study of Diabetes and Self-Monitoring, Blood Glucose, run by VA Office of Research and Development at 3 sites in United States.
Trial summary
The purpose of this study is to better understand disparities in insulin dosing, hemoglobin A1c, and self-reported patient self-care behaviors among non-Hispanic white, Hispanic, and African American veterans with type 2 diabetes receiving VA care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Self-Monitoring, Blood Glucose
- How many people
- 1,248 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2005to Jun 2008
- Phase
- Observational
- 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
Study population: insulin-using diabetics in VISN 18
Who may be able to join
- Must be in VISN 18 VISTA database
- Diabetic
- Using insulin
Who cannot join
- Unwilling to participate
Trial locations and contacts
3 sites in 1 country.
United States3 sites
New Mexico VA Health Care System, Albuquerque, NM
Albuquerque, New Mexico, 87108-5153
Phoenix VA Health Care System, Phoenix, AZ
Phoenix, Arizona, 85012
Southern Arizona VA Health Care System, Tucson, AZ
Tucson, Arizona, 85723
About this study
Official title: Insulin Treatment Variation in Southwestern Diabetics - Therapeutic Decision-making
The purpose of this study is to better understand disparities in insulin dosing, hemoglobin A1c, and self-reported patient self-care behaviors among non-Hispanic white, Hispanic, and African American veterans with type 2 diabetes receiving VA care.
Read the detailed description
Background: Minority populations are disproportionately affected by type 2 diabetes mellitus (T2DM), likely due to an interaction of genetic and environmental risk factors. Several studies have documented a higher prevalence of insulin resistance, disparities in quality of care, and more microvascular and macrovascular complications in minority groups. Recent evidence by our research group indicates that insulin-using minority veterans have poorer glycemic control (as measured by HbA1c) and receive lower doses of insulin than do non-Hispanic white patients.
Objectives: The goal of this mixed methods descriptive, cross-sectional study is to elucidate the patient, provider and interactive patient/provider reasons for this discrepancy, to determine and validate these findings in a much larger sample, and to use what is discovered to develop strategies to remedy provider and patient behaviors in order to optimize health outcomes. The objective of this mixed method study is to unpack provider decision-making and patient self-care behaviors responsible for ethnic and racial variation in the use of insulin in veterans with T2DM receiving VA care, while adjusting for important covariates and confounders. Aim 1: Perform a qualitative provider Nominal Group Technique designed to elucidate insulin prescribing decision-making behaviors, and possible reasons for racial/ethnic variation in insulin use. Aim 2: Perform a qualitative content analysis of patient focus group data on insulin-using veterans in VA care across African American, Hispanic and non-Hispanic White (NHW) contrasts. Psychosocial determinants of self-care, diabetes care preferences, patient/provider relationship issues, and possible reasons for racial/ethnic variation in insulin use will be explored. Aim 3: Construct a) patient, and b) provider questionnaires reflective of qualitative focus group data, nominal group process and extant evidence-base findings, and Aim 4: Administer surveys to a) a racially/ethnically diverse random sample of insulin-using diabetic veterans receiving care within VISN 18, and b) their assigned primary care providers.
Methods: This is a mixed methods descriptive, cross-sectional study using 1) qualitative nominal group technique data (from providers), focus group data (from patients) and 2) provider and nested patient survey data. The investigators will use qualitative methods to explicate and deconstruct the etiologic associations and management strategies of insulin-using patients and their providers using focus group content analytical methods. Next, the investigators will use the extant evidence from the evidence-base, focus group data and conventional survey methods to construct two surveys-one targeted to providers and another to survey a randomly selected population of representative veterans nested within their providers VA care, following the recommendations of Hughes, O'Brien and Dillman.
Status: Completed.
- Conditions
- Diabetes, Self-Monitoring, Blood Glucose
- Keywords
- Decision-making, Insulin, Preference, Treatment Variation, Provider, Patient
- Medical subject headings
- Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
diabetes self-care/attitudes
Measured: single survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionAug 2007
- Study completionJun 2008
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.
- More trials run by VA Office of Research and DevelopmentThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,248 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Glen H Murata, MD, Principal investigator, New Mexico VA Health Care System, Albuquerque, NM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00148304
- Sponsor's protocol ID
- IIR 04-176
- Status last verified
- Jun 2016
- First submitted
- 2 Sep 2005
- Last updated
- 6 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Treatment Variation in Southwestern Diabetics - Therapeutic Decision-making
- ClinicalTrials.gov ID
- NCT00148304
- Acronym / sponsor ID
- IIR 04-176
- Conditions
- Diabetes, Self-Monitoring, Blood Glucose
- Keywords
- Decision-making, Insulin, Preference, Treatment Variation, Provider, Patient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,248 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Sep 2005
- Primary completion
- Aug 2007 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 7 Sep 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 better understand disparities in insulin dosing, hemoglobin A1c, and self-reported patient self-care behaviors among non-Hispanic white, Hispanic, and African American veterans with type 2 diabetes receiving VA care.
Detailed description
Background: Minority populations are disproportionately affected by type 2 diabetes mellitus (T2DM), likely due to an interaction of genetic and environmental risk factors. Several studies have documented a higher prevalence of insulin resistance, disparities in quality of care, and more microvascular and macrovascular complications in minority groups. Recent evidence by our research group indicates that insulin-using minority veterans have poorer glycemic control (as measured by HbA1c) and receive lower doses of insulin than do non-Hispanic white patients.
Objectives: The goal of this mixed methods descriptive, cross-sectional study is to elucidate the patient, provider and interactive patient/provider reasons for this discrepancy, to determine and validate these findings in a much larger sample, and to use what is discovered to develop strategies to remedy provider and patient behaviors in order to optimize health outcomes. The objective of this mixed method study is to unpack provider decision-making and patient self-care behaviors responsible for ethnic and racial variation in the use of insulin in veterans with T2DM receiving VA care, while adjusting for important covariates and confounders. Aim 1: Perform a qualitative provider Nominal Group Technique designed to elucidate insulin prescribing decision-making behaviors, and possible reasons for racial/ethnic variation in insulin use. Aim 2: Perform a qualitative content analysis of patient focus group data on insulin-using veterans in VA care across African American, Hispanic and non-Hispanic White (NHW) contrasts. Psychosocial determinants of self-care, diabetes care preferences, patient/provider relationship issues, and possible reasons for racial/ethnic variation in insulin use will be explored. Aim 3: Construct a) patient, and b) provider questionnaires reflective of qualitative focus group data, nominal group process and extant evidence-base findings, and Aim 4: Administer surveys to a) a racially/ethnically diverse random sample of insulin-using diabetic veterans receiving care within VISN 18, and b) their assigned primary care providers.
Methods: This is a mixed methods descriptive, cross-sectional study using 1) qualitative nominal group technique data (from providers), focus group data (from patients) and 2) provider and nested patient survey data. The investigators will use qualitative methods to explicate and deconstruct the etiologic associations and management strategies of insulin-using patients and their providers using focus group content analytical methods. Next, the investigators will use the extant evidence from the evidence-base, focus group data and conventional survey methods to construct two surveys-one targeted to providers and another to survey a randomly selected population of representative veterans nested within their providers VA care, following the recommendations of Hughes, O'Brien and Dillman.
Status: Completed.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- insulin-using diabetics in VISN 18
Key inclusion criteria (3 listed)
- Must be in VISN 18 VISTA database
- Diabetic
- Using insulin
Key exclusion criteria (1 listed)
- Unwilling to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
diabetes self-care/attitudes
Time frame: single survey
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 6 Jun 2016.
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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.
Glen H Murata, MD principal investigator
New Mexico VA Health Care System, Albuquerque, NM
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Self-Monitoring, Blood Glucose, run by VA Office of Research and Development at 3 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 3 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 6 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
diabetes self-care/attitudes (time frame: single survey). 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 6 Jun 2016.