- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04414982
An Intervention to Increase Engagement With Hypertension Care for American Indian Patients
The objective of this study is to reduce the effects of stereotype threat on the adherence of American Indian/Alaska Native patients with hypertension.
The specific aims of this study, which employs a values affirmation intervention, are to:
- Compare the effects of the values-affirmation exercise with a control exercise in AI/AN patients with hypertension.
- Compare the effects of the values-affirmation exercise in AI/AN patients with its effects in white patients.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
American Indians and Alaska Natives (AI/ANs) in the U.S. bear a disproportionate burden of cardiovascular disease. They have a higher prevalence of conditions that predispose to cardiovascular disease and poorer outcomes after developing cardiovascular disease than white Americans. The causes of these differences are complex and multiple, but there are widespread concerns that racial bias contributes to the problem. As concluded over a decade ago in the 2003 Institute of Medicine report, Unequal Treatment, "Racial/ethnic disparities in health care occur in the context of broader historic and contemporary social and economic inequality and evidence of persistent racial and ethnic discrimination… Bias, stereotyping and prejudice on the part of healthcare providers may contribute to racial and ethnic disparities in health care." These concerns persist. Minority group members are well aware of negative stereotypes targeted at them as a group and of the possibility of bias directed at them as individuals. Given the reality of prejudice and their previous experiences with it, it is understandable that minority group members would be apprehensive about the possibility of being judged in light of the stereotype, both outside and inside the healthcare system. Critically, this apprehension may occur in the absence of actual bias. This raises the possibility that interventions directed at patients' perception of discrimination may have an independent and additive effect beyond the effects of interventions directed at provider bias.
Investigators propose to evaluate a novel intervention that reduces the detrimental effects of negative stereotypes on minority patients by reducing stereotype threat through values- affirmation. Stereotype threat is a stressful psychological state that occurs when a person fears being judged in light of negative stereotypes. The stress of this situation and the pressure to avoid confirming negative stereotypes can result in impaired performance and worse outcomes - something of a self-fulfilling prophecy. For example, an American Indian patient fearful of confirming the stereotype of being unintelligent may fail to ask for clarification of changes in antihypertensive medications and, based on misconceptions, persist in taking an old regimen that is ineffective. Values-affirmation is a process in which global sense of personal worth is strengthened in the face of a threat, making individuals better able to cope with psychological threats.
The intervention proposed in this application is based on one found to be effective in alleviating stereotype threat in other contexts such as education and in alleviating more general threats to the self in a health context as well as in a prior study investigators performed with African American patients. Investigators will randomly assign AI/AN patients with hypertension to complete an affirmation exercise or a control exercise prior to a visit with their providers. The affirmation exercise is performed immediately before a clinic visit. It asks patients to reflect on values or self-defining skills that they find important, and to write a few sentences about why one of them is important. The project is innovative in that it is directed against a mechanism, stereotype threat, not generally recognized as important in healthcare settings. Since the intervention is brief and easily applied across a wide range of health conditions, it directly addresses the need for interventions to be generalizable and sustainable.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Colorado
-
Denver, Colorado, United States, 80204
- Denver Health and Hospital Authority
-
Denver, Colorado, United States, 80204
- Denver Indian Health and Family Services
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Hypertension diagnosis: primary or secondary ICD-10 code diagnosis in last 24 mo
- SBP >160 mm Hg or DBP >90 mm Hg in last 12 months
- Currently taking antihypertensive medications
- Medications filled within health system's pharmacy
- White or American Indian/Alaska Native, self-reported race
- Upcoming primary care visit
- Ability to read and write English
- History of hypertension defined as having an outpatient visit in the past year with a primary or secondary ICD-9 code diagnosis of hypertension, with the diagnosis of hypertension confirmed by review of the patient's medical record before enrollment.
- Additional inclusion criteria are age >18 years
- Use of Denver Indian Health and Family Services (DIHFS) or Denver Health (DH) as their usual source of care.
- American Indian/Alaska Native as defined by DIHFS uses to define eligibility for no-cost services.
- To define the comparator group at DH we will use self-described race/ethnicity of white/non- Latino.
- All eligible patients must have the ability to provide informed consent.
Exclusion Criteria:
- Pregnancy-related hypertension
- Dialysis-dependent end-stage renal disease
- Patients who cannot speak or write English
- Unable to provide consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Values Affirmation
Compare the effects of the values-affirmation exercise with a control exercise in AI/AN patients with hypertension.
|
Participants are asked to circle the two or three values that are MOST important to them.
Next, participants are asked to think about times when the values chosen might be important to THEMSELVES and then write a few sentences to describe when and why they might be important.
|
Active Comparator: Control Values Affirmation
Compare the effects of the values-affirmation exercise in AI/AN patients with its effects in white patients.
|
Participants are asked to circle the two or three items that are LEAST important to them.
Next, participants are asked to think about times when the values chosen might be important to SOMEONE ELSE and then write a few sentences to describe when and why they might be important.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Antihypertensive Medication Adherence using Pharmacy Records
Time Frame: Baseline, 3 and 6 months
|
This antihypertensive medication adherence outcome will be a summary measure of adherence which assesses the proportion of days covered (PDC) over the period of observation for which a patient obtains antihypertensive medications.
Adherence will be calculated for each antihypertensive drug in the regimen and combined across drugs into a summary measure of adherence for the entire drug regimen.
|
Baseline, 3 and 6 months
|
Change in Antihypertensive Medication Adherence using Self-Reported Adherence
Time Frame: Baseline, 3 and 6 months
|
This antihypertensive medication adherence outcome will be a summary measure of self-reported adherence using the validated Voils instrument, which has 3 questions that address adherence over the previous 7 days.
|
Baseline, 3 and 6 months
|
Change in Antihypertensive Medication Adherence using Pill Counts
Time Frame: Baseline, 3 and 6 months
|
This antihypertensive medication adherence outcome will be a summary outcome measure of adherence where if x is the number of pills in the bottle, y is the number of pills that would have been in the bottle had all pills been taken since the bottle was filled, and z is the number of pills that should have been taken since the last fill, and adherence is calculated as 1- [(x-y)/z].
|
Baseline, 3 and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Systolic Blood Pressure
Time Frame: Baseline, 3 and 6 months
|
Systolic blood pressure over time.
|
Baseline, 3 and 6 months
|
Proportion of Time Blood Pressure is Under Control
Time Frame: 6 months
|
Defined as the proportion of time over the 6-months of follow-up with a BP ≤ 160/90 mmHg
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ed Havranek, MD, University of Colorad, Denver
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-1711
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypertension
-
National Taiwan University Hospital Hsin-Chu BranchRecruitingHypertension,Essential | Hypertension, MaskedTaiwan
-
University of Alabama at BirminghamTroy UniversityCompletedHypertension | Hypertension, Resistant to Conventional Therapy | Uncontrolled Hypertension | Hypertension, White CoatUnited States
-
BayerCompletedPrimary HypertensionChina
-
Columbia UniversityAgency for Healthcare Research and Quality (AHRQ)Active, not recruitingWhite Coat Hypertension | Hypertension,EssentialUnited States
-
Addpharma Inc.Completed
-
Universidade Federal de Santa MariaCompletedHealthy Volunteers | Hypertension, EssentialBrazil
-
Sheffield Teaching Hospitals NHS Foundation TrustUniversity of SheffieldCompletedIdiopathic Pulmonary Arterial Hypertension | Chronic Thromboembolic Pulmonary HypertensionUnited Kingdom
-
China Academy of Chinese Medical SciencesGuang'anmen Hospital of China Academy of Chinese Medical SciencesCompletedHypertension, Resistant to Conventional Therapy | Primary HypertensionChina
-
Cytos Biotechnology AGCompletedMild Essential Hypertension | Moderate Essential HypertensionSwitzerland
Clinical Trials on Intervention Values Affirmation
-
University of Colorado, DenverNational Heart, Lung, and Blood Institute (NHLBI); Kaiser Permanente; University... and other collaboratorsCompletedHypertensionUnited States
-
Kaiser PermanenteNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedHealth Communication | Preventive Health ServicesUnited States
-
The Miriam HospitalNational Institute on Aging (NIA)CompletedHeart FailureUnited States
-
George Mason UniversityOAR, Fairfax; Slonky, IncUnknownSubstance Use | HIV Risk Behavior
-
The Miriam HospitalNational Institute on Aging (NIA)RecruitingHeart FailureUnited States
-
Wake Forest UniversityStanford University; Relay Graduate School of EducationTerminated
-
Weill Medical College of Cornell UniversityNational Heart, Lung, and Blood Institute (NHLBI)Completed
-
University of CyprusYouth Board of CyprusCompleted
-
University of California, DavisNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Kaiser...Enrolling by invitationDiabetes Mellitus, Type 2 | Diabetes, GestationalUnited States
-
Stanford UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)TerminatedObesity, ChildhoodUnited States