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.
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
About this study
- Determine racial/ethnic differences in trust in physicians and mistrust of the health care system among veterans with Type 2 Diabetes.
- 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 group | Role | What they receive |
|---|---|---|
| Group 1 | Adults (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.
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
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)
Hemoglobin A1c
Measured: 12 months after enrollment
Systolic Blood Pressure
Measured: 12-months after enrollment
Diastolic Blood Pressure
Measured: 12-months after enrollment
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.
- First posted2 Oct 2006 (estimated)
- Study startNov 2004
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Leonard E. Egede, MD MS, Principal investigator, Ralph H. Johnson VA Medical Center, Charleston, SC
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Racial/Ethnic Differences in Trust/Mistrust and Its Effect on Diabetes Outcomes
- ClinicalTrials.gov ID
- NCT00383110
- Acronym / sponsor ID
- LIP 82-001
- Conditions
- Diabetes
- Keywords
- Diabetes, Health Outcomes, Racial Preference, Clinical Trial, Ethnic Differences
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Nov 2004
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 2 Oct 2006 (estimated)
- Results
- Posted 17 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Determine racial/ethnic differences in trust in physicians and mistrust of the health care system among veterans with Type 2 Diabetes.
- 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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Adults (age 18 or older) with type 2 diabetes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- equal number of White and Black Americans over the age of 18 with Type II diabetes
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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
General Trust in Physicians Scale (GTIPS)
Time frame: 12 months following enrollment
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.
Health Care System Distrust Scale
Time frame: 12 months after enrollment
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.
4 secondary outcomes
Hemoglobin A1c
Time frame: 12 months after enrollment
Systolic Blood Pressure
Time frame: 12-months after enrollment
Diastolic Blood Pressure
Time frame: 12-months after enrollment
LDL-cholesterol
Time frame: 12-months after enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Leonard E. Egede, MD MS principal investigator
Ralph H. Johnson VA Medical Center, Charleston, SC
1 site in 1 country: see every site and its status.
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.