HypertensionNCT04414982
An Intervention to Increase Engagement With Hypertension Care for American Indian Patients
A study testing Intervention Values Affirmation in people with Hypertension, run by University of Colorado, Denver at 2 sites in United States.
Trial summary
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: 1. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Intervention Values Affirmation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 339 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2015to 30 Jun 2020
- Phase
- Interventional
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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.
Who cannot join
- Pregnancy-related hypertension
- Dialysis-dependent end-stage renal disease
- Patients who cannot speak or write English
- Unable to provide consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Denver Health and Hospital Authority
Denver, Colorado, 80204
Denver Indian Health and Family Services
Denver, Colorado, 80204
About this study
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Intervention Values Affirmation, Control Values Affirmation
- Keywords
- Hypertension, Medication Adherence, Values Affirmation, American Indian/Alaska Native
- Medical subject headings
- Hypertension, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention Values AffirmationBehavioural
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.
Control Values AffirmationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Values Affirmation | Experimental | Compare the effects of the values-affirmation exercise with a control exercise in AI/AN patients with hypertension. Receives: Behavioral: Intervention Values Affirmation |
| Control Values Affirmation | Active comparator | Compare the effects of the values-affirmation exercise in AI/AN patients with its effects in white patients. Receives: Behavioral: Control Values Affirmation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Antihypertensive Medication Adherence using Pharmacy Records
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.
Measured: Baseline, 3 and 6 months
Change in Antihypertensive Medication Adherence using Self-Reported Adherence
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.
Measured: Baseline, 3 and 6 months
Change in Antihypertensive Medication Adherence using Pill Counts
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].
Measured: Baseline, 3 and 6 months
Secondary outcomes (2)
Systolic Blood Pressure
Systolic blood pressure over time.
Measured: Baseline, 3 and 6 months
Proportion of Time Blood Pressure is Under Control
Defined as the proportion of time over the 6-months of follow-up with a BP ≤ 160/90 mmHg
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 Sep 2015
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
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 HypertensionStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 339 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association, University of Colorado Centers for American Indian and Alaska Native Health, Denver Health and Hospital Authority, Denver Indian Health and Family Services
- Responsible party
- Sponsor
- Investigators
- Ed Havranek, MD, Principal investigator, University of Colorad, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04414982
- Sponsor's protocol ID
- 15-1711
- Status last verified
- Aug 2020
- First submitted
- 29 May 2020
- Last updated
- 1 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gust CJ, Bryan AD, Havranek EP, Vupputuri S, Steiner JF, Blair IV, Hanratty R, Daugherty SL. Health Behavior Theory and Hypertension Management: Comparisons Among Black, White, and American Indian and Alaska Native Patients. Race Soc Probl. 2022 Dec;14(4):369-382. doi: 10.1007/s12552-022-09359-2. Epub 2022 Feb 25.
PubMed 38322707
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intervention to Increase Engagement With Hypertension Care for American Indian Patients
- ClinicalTrials.gov ID
- NCT04414982
- Acronym / sponsor ID
- 15-1711
- Conditions
- Hypertension
- Keywords
- Hypertension, Medication Adherence, Values Affirmation, American Indian/Alaska Native
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 339 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- American Heart Association, University of Colorado Centers for American Indian and Alaska Native Health, Denver Health and Hospital Authority, Denver Indian Health and Family Services
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 4 Jun 2020 (actual)
- 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 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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Values Affirmation | Experimental | Behavioral: Intervention Values AffirmationCompare the effects of the values-affirmation exercise with a control exercise in AI/AN patients with hypertension. |
| Control Values Affirmation | Active comparator | Behavioral: Control Values AffirmationCompare the effects of the values-affirmation exercise in AI/AN patients with its effects in white patients. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (4 listed)
- Pregnancy-related hypertension
- Dialysis-dependent end-stage renal disease
- Patients who cannot speak or write English
- Unable to provide 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 |
|---|---|---|
| Intervention Values AffirmationParticipants 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. | Behavioural | Intervention Values Affirmation |
| Control Values AffirmationParticipants 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. | Behavioural | Control Values Affirmation |
Primary outcome
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.
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.
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].
2 secondary outcomes
Systolic Blood Pressure
Time frame: Baseline, 3 and 6 months
Proportion of Time Blood Pressure is Under Control
Time frame: 6 months
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 1 Sep 2020.
- Derived from this study: PubMed 38322707Gust CJ, Bryan AD, Havranek EP, Vupputuri S, Steiner JF, Blair IV, Hanratty R, Daugherty SL. Health Behavior Theory and Hypertension Management: Comparisons Among Black, White, and American Indian and Alaska Native Patients. Race Soc Probl. 2022 Dec;14(4):369-382. doi: 10.1007/s12552-022-09359-2. Epub 2022 Feb 25.
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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.
Ed Havranek, MD principal investigator
University of Colorad, Denver
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Values Affirmation in people with Hypertension, run by University of Colorado, Denver at 2 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 13 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 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Change in Antihypertensive Medication Adherence using Pharmacy Records (time frame: Baseline, 3 and 6 months). The study lists 3 primary outcomes in all. 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 NCT04414982, 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 1 Sep 2020.