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Controlling Hypertension in Native American and Other Populations

Controlling Hypertension in Native American and Other Populations

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03135405
Enrollment
295
Registered
2017-05-01
Start date
2017-04-11
Completion date
2019-02-28
Last updated
2019-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief summary

The study evaluates the use of automated motivational messages, visit reminders, and medication reminders (using interactive voice response technology or text messages) to improve blood pressure control among adults with hypertension that receive their care at the First Nations Community Healthsource clinic in Albuquerque, New Mexico. Half of the participants will receive usual care, while the other half will receive the automated calls or text messages and have the option to receive home blood pressure monitors and/or designate a care partner who will also receive messages. Participants will be followed for 12 months.

Detailed description

American Indians and Alaskan Natives (AI/ANs) face pervasive health disparities in comparison to other racial and ethnic groups in the United States. Treatment of hypertension is a pillar of cardiovascular disease prevention. Hypertension is the most common chronic health condition in the U.S. Uncontrolled hypertension increases the risk of acute myocardial infarction, stroke, kidney failure, and congestive heart failure. Hypertension rates are high, levels of control are low, and disparities in care are evident in AI/AN populations. This study will take place at First Nations Community Healthsource (FNCH) in Albuquerque, New Mexico. FNCH provides primary medical care to urban AI/AN and other socially disadvantaged residents of the Albuquerque, New Mexico area. Approximately 40% of FNCH clients are AI/AN; Diné (Navajo) is the most common tribal affiliation. Many other clients served by FNCH are undocumented immigrants. Housing insecurity and homelessness are common. This study will use a FNCH hypertension registry to identify all clients with hypertension (regardless of race or ethnicity). From this group, the study will recruit 512 clients, and randomize the participants without stratification to receive automated messages using an interactive voice recognition and text message intervention or to continue in usual care. Consistent with the principles of pragmatic randomized clinical trials, the study has few exclusion criteria in order to maximize inclusion of clients and generalizability of findings. Potentially eligible clients will be contacted by letter and phone. Those who express interest will complete a baseline visit where they provide informed consent, complete a baseline survey, and have blood pressure measured. The participants will then be randomized either to the intervention or usual care arms. Individuals randomized to the intervention arm will receive: reminders of upcoming appointments at FNCH; requests to reschedule missed appointments; reminders to refill medications; and weekly motivational messages to encourage self-care, appointment keeping, and medication-taking for hypertension. These participants will be offered a home blood pressure monitor and trained to use it if they accept, and will be asked if they wish to nominate a care partner to also receive notices of upcoming and missed appointments. In additional to their usual visits at FNCH, all participants will complete research visits with our study coordinators at 6 and 12 months, where they will again have BP measured and complete brief surveys.

Interventions

BEHAVIORALAutomated messages

Automated motivational messages and visit and medication reminders will be provided via interactive voice response calls or text messages.

BEHAVIORALHome BP monitors

Participants will have the option of receiving home blood pressure monitors.

BEHAVIORALCare partner reminders

Participants will have the option of designating a care partner who will also receive automated reminder calls or text messages.

Sponsors

American Heart Association
CollaboratorOTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
University of Colorado, Denver
CollaboratorOTHER
Kaiser Permanente
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 79 Years
Healthy volunteers
No

Inclusion criteria

* At least two prior visits to First Nations Community Healthsource with blood pressure measurements, with at least one visit in the 24 months prior * Hypertension * Between ages 21-79

Exclusion criteria

* Another preferred site of primary care * Significant impairment of vision and hearing * Life-limiting illness * Renal dialysis * Receipt of home health care, hospice services or residence in a nursing home * Dementia * Pregnancy * Current incarceration * Homeless * No land line or cellular phone access

Design outcomes

Primary

MeasureTime frameDescription
Systolic blood pressure12-monthsChange in systolic blood pressure from baseline

Secondary

MeasureTime frameDescription
Diastolic blood pressure12-monthsChange in diastolic blood pressure from baseline
Medication adherence12-monthsSelf-reported medication adherence using the Voils instrument
Visit adherence12-monthsProportion of scheduled appointments that are kept, missed or cancelled

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026