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DiabetesNCT00383110

Racial/Ethnic Differences in Trust/Mistrust and Its Effect on Diabetes Outcomes

An observational study of Diabetes, run by US Department of Veterans Affairs at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

1. Determine racial/ethnic differences in trust in physicians and mistrust of the health care system among veterans with Type 2 Diabetes. 2. Determine the predictive power of trust in physicians and mistrust of the health care system on personal health practices and health outcomes in a prospective cohort of veterans… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes
How many people
300 participants
Where
1 siteUnited States
Study dates
Nov 2004to Jan 2009
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

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: equal number of White and Black Americans over the age of 18 with Type II diabetes

Who may be able to join

  • Patients for this study will be recruited from the Ralph H. Johnson VAMC in Charleston, South Carolina.
  • American veterans aged 18 years and older with Type 2 Diabetes will be recruited.

Who cannot join

  • Children will not be included as this study pertains to type 2 diabetes, which is not a disease of children.
  • Non-English speaking patients are excluded to eliminate bias in the response to questionnaires because these questionnaires have only been validated in English speaking patients.
  • We decided to exclude cognitively impaired individuals because of the complexity of the survey instruments.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Ralph H. Johnson VA Medical Center, Charleston, SC

    Charleston, South Carolina, 29401-5799

Other trials in United States

About this study

  1. Determine racial/ethnic differences in trust in physicians and mistrust of the health care system among veterans with Type 2 Diabetes.
  2. Determine the predictive power of trust in physicians and mistrust of the health care system on personal health practices and health outcomes in a prospective cohort of veterans with Type 2 Diabetes
Read the detailed description

Background/Significance: Diabetes mellitus is a chronic and progressive disease that causes significant morbidity and mortality and increases health care utilization and costs in both Veteran Administration (VA) and non-VA settings. 1. Diabetes and its complications are more prevalent in minority populations. Black Americans have two-fold increased age adjusted rates of diabetes, are more likely to develop and experience greater disability from diabetes complications compared to White Americans. 1. Black Americans with diabetes have higher rates of retinopathy, end-stage renal disease, lower limb amputations, and overall death rates. 2. Therefore, diabetes is a significant public health problem and Black American patients have disproportionately higher morbidity and mortality than their White American counterparts.

Several factors have been postulated to explain the disproportionately higher morbidity and mortality from diabetes in Black Americans and these include their mistrust of the health care system. 3. It is thought that distrustful patients are less likely to seek routine medical care, take prescribed medications consistently, adhere to treatments recommendations, and maintain continuity with health care providers and health care systems. 4. Recent studies show that Black Americans are less trusting of physicians and the health care system. 5. However, little is known about the association between trust and diabetes outcomes and whether distrust of physicians and the health care system contributes to the observed racial/ethnic differences in diabetes outcomes.

Theoretical Framework: The conceptual and theoretical framework of this study is the revised behavioral model of health services use (Andersen 1974, 1968, 1983, 1995). The model posits that people's use of health services is a function of their predisposition to use services, factors that enable or impede use, and their need for care (Andersen 1995). Trust in physicians and the health system falls under health beliefs (attitudes toward health services), which is one of the predisposing factors that is thought to predict health services utilization and health outcomes. Thus, people with high levels of trust in physicians and the health care system are expected to have more effective access, appropriate health utilization, and better health outcomes. The model has been revised to include veteran-specific variables such as level of service entitlement, period of service, duration in the VA system, and disability status and to measure both health services use and health outcomes.

Research Design and Methods: This is a prospective cohort study with five hypotheses organized under their specific aims as follows:

Specific Aim #1: Determine racial/ethnic differences in trust in physicians and mistrust of the health care system among veterans with Type 2 Diabetes.

Hypothesis #1: There is a difference in mean scores on the general trust in physician scale (GTIPS) between White and Black American veterans with Type 2 diabetes.

Hypothesis #2: There is a difference in mean scores on the Health Care System Distrust Scale between White and Black American veterans with Type 2 diabetes.

Specific Aim #2: Determine the predictive power of trust in physicians and mistrust of the health care system on personal health practices and health outcomes in a prospective cohort of veterans with Type 2 Diabetes

Hypothesis #1: Controlling for predisposing, enabling, need, and veteran-specific factors, diabetic veterans with lower trust scores or higher mistrust scores will be less likely to keep office appointments, take prescribed medications, and adhere to diabetes self-management recommendations after 12 months of follow-up.

Hypothesis #2: Controlling for predisposing, enabling, need, and veteran-specific factors, diabetic veterans with lower trust scores or higher mistrust scores will have higher mean hemoglobin A1C, blood pressure, and LDL cholesterol levels after 12 months of follow-up.

Hypothesis #3: Controlling for predisposing, enabling, need, and veteran-specific factors, diabetic veterans with lower trust scores or higher mistrust scores will be less likely to accept influenza vaccination after 12 months of follow-up.

Study site \& Subjects: Patients will be recruited from the Charleston VAMC. Equal number of White and Black American veterans aged 18 years and older with Type 2 Diabetes will be recruited. Race/ethnicity will be based on self-report. The diagnosis of type 2 Diabetes as well as health utilization and diabetes-specific health outcomes will be obtained from the VA electronic medical records system (CPRS). There are approximately 6,961 patients with Type 2 Diabetes at this site, of which 49.1% (3,417) are White Americans, 31.5% (2,189) are Black Americans, and 19.4% (1,355) are Hispanic or other. Approximately 97.5% are men and 90% are aged 50 years or older.

Sample size calculation:

Specific Aim #1: Sample Power V2.0 (SPSS) was used for sample size calculation based on the convention outlined by Cohen6. Overall experiment wise error was held to ?=0.05, and power to 80% using medium (0.25) effect sizes. Correction for multiplicity of tests (2 tests for primary hypotheses) involved using ?=0.025 (0.05/2). This yielded 125 patients per group. In addition, the sample was inflated to account for an estimated 20% attrition at 1 year of follow-up (death, relocation, or loss to follow-up). No more than 150 eligible patients need to be enrolled per group. Thus, 300 patients (150 Whites and 150 African Americans) will be recruited.

Specific Aim #2: The sample size determination for a reliable regression equation offered by Stevens7 is 15 subjects per predictor variable. Using this standard, a sample size of 300, as determined above, would allow the inclusion of 20 predictor variables. Because none of the hypotheses for Specific Aim 2 exceed 20 predictor variables, a sample of 300 will be adequate.

Survey Instruments: The GTIPS4 is a valid and reliable 11-item measure of general trust in physicians and the Health Care System Distrust Scale is a valid and reliable 10-item measure of mistrust of the health care system. Both instruments have been validated in Black and White Americans.

Statistical Analysis Plan: Descriptive statistics will be used to describe the characteristics of participants in the study.

Specific Aim #1: Mean scores on the trust and mistrust scales at baseline will be compared between White and Black Americans with the two-sample t-test and similar comparisons will be made while controlling for covariates (predisposing, enabling, need, and veteran-specific factors) using Analysis of Covariance (ANCOVA).

Specific Aim #2: Multiple linear regression will be used to test the effect of mean trust/mistrust scores on health utilization and mean hemoglobin A1C, blood pressure, and LDL cholesterol after 12 months of follow-up controlling for covariates. Similarly, multiple logistic regression will be used to test the effect of trust/mistrust on acceptance of the influenza vaccine controlling for covariates. STATA V8.0 will be used for data analysis and all tests will be two-tailed with overall p=0.05 for each hypothesis.

Conditions
Diabetes
Keywords
Diabetes, Health Outcomes, Racial Preference, Clinical Trial, Ethnic Differences
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00383110
Study groupRoleWhat they receive
Group 1Adults (age 18 or older) with type 2 diabetes.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. General Trust in Physicians Scale (GTIPS)

    The GTIPS is a valid and reliable 11-item measure of general trust in physicians in the domains of dependability, confidence, and confidentiality of information. All items are fashioned in a 5-point Likert format with a minimum score of 11 and maximum of 55. Higher scores indicate more trust in physicians.

    Measured: 12 months following enrollment

  2. Health Care System Distrust Scale

    Health Care System Distrust Scale is a valid and reliable 10-item measure of distrust of the health care system, measuring honesty confidentiality and confidence. All questions are measured on a Likert scale, with scores ranging from a minimum of 10 to a maximum of 50. Higher scores indicate more distrust in the health care system.

    Measured: 12 months after enrollment

Secondary outcomes (4)
  1. Hemoglobin A1c

    Measured: 12 months after enrollment

  2. Systolic Blood Pressure

    Measured: 12-months after enrollment

  3. Diastolic Blood Pressure

    Measured: 12-months after enrollment

  4. LDL-cholesterol

    Measured: 12-months after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2006 (estimated)
  2. Study startNov 2004
  3. Primary completionJan 2009
  4. Study completionJan 2009

Resources

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
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00383110
Sponsor's protocol ID
LIP 82-001
Other IDs
HR#11259
Status last verified
Jun 2014
First submitted
28 Sep 2006
Last updated
28 Apr 2015
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes, 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 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 28 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?

Yes. Results are posted in the registry (first posted 17 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

General Trust in Physicians Scale (GTIPS) (time frame: 12 months following enrollment). The study lists 2 primary outcomes in all. 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 28 Apr 2015.

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