An Intervention to Increase Engagement With Hypertension Care for American Indian Patients
1 other identifier
interventional
339
1 country
2
Brief 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.Compare the effects of the values-affirmation exercise with a control exercise in AI/AN patients with hypertension.
- 2.Compare the effects of the values-affirmation exercise in AI/AN patients with its effects in white patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hypertension
Started Sep 2015
Longer than P75 for not_applicable hypertension
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 29, 2020
CompletedFirst Posted
Study publicly available on registry
June 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedSeptember 1, 2020
August 1, 2020
4.8 years
May 29, 2020
August 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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.
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- \[(x-y)/z\].
Baseline, 3 and 6 months
Secondary Outcomes (2)
Systolic Blood Pressure
Baseline, 3 and 6 months
Proportion of Time Blood Pressure is Under Control
6 months
Study Arms (2)
Intervention Values Affirmation
EXPERIMENTALCompare the effects of the values-affirmation exercise with a control exercise in AI/AN patients with hypertension.
Control Values Affirmation
ACTIVE COMPARATORCompare the effects of the values-affirmation exercise in AI/AN patients with its effects in white patients.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- Pregnancy-related hypertension
- Dialysis-dependent end-stage renal disease
- Patients who cannot speak or write English
- Unable to provide consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colorado, Denverlead
- American Heart Associationcollaborator
- University of Colorado Centers for American Indian and Alaska Native Healthcollaborator
- Denver Health and Hospital Authoritycollaborator
- Denver Indian Health and Family Servicescollaborator
Study Sites (2)
Denver Health and Hospital Authority
Denver, Colorado, 80204, United States
Denver Indian Health and Family Services
Denver, Colorado, 80204, United States
Related Publications (1)
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.
PMID: 38322707DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ed Havranek, MD
University of Colorad, Denver
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2020
First Posted
June 4, 2020
Study Start
September 1, 2015
Primary Completion
June 30, 2020
Study Completion
June 30, 2020
Last Updated
September 1, 2020
Record last verified: 2020-08