Controlling Hypertension in Native American and Other Populations
NCT ID: NCT03135405
Last Updated: 2019-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
295 participants
INTERVENTIONAL
2017-04-11
2019-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Usual care
No interventions assigned to this group
Intervention
Automated messages
Automated motivational messages and visit and medication reminders will be provided via interactive voice response calls or text messages.
Home BP monitors
Participants will have the option of receiving home blood pressure monitors.
Care partner reminders
Participants will have the option of designating a care partner who will also receive automated reminder calls or text messages.
Interventions
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Automated messages
Automated motivational messages and visit and medication reminders will be provided via interactive voice response calls or text messages.
Home BP monitors
Participants will have the option of receiving home blood pressure monitors.
Care partner reminders
Participants will have the option of designating a care partner who will also receive automated reminder calls or text messages.
Eligibility Criteria
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Inclusion Criteria
* Hypertension
* Between ages 21-79
Exclusion Criteria
* 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
21 Years
79 Years
ALL
No
Sponsors
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American Heart Association
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Colorado, Denver
OTHER
Kaiser Permanente
OTHER
Responsible Party
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Emily Schroeder
Investigator
Principal Investigators
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Emily B Schroeder, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Kaiser Permanente
Locations
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First National Community Healthsource
Albuquerque, New Mexico, United States
Countries
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References
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Schroeder EB, Moore KR, Manson SM, Baldwin MA, Goodrich GK, Malone AS, Pieper LE, Xu S, Fort MP, Son-Stone L, Johnson D, Steiner JF. A randomized clinical trial of an interactive voice response and text message intervention for individuals with hypertension. J Clin Hypertens (Greenwich). 2020 Jul;22(7):1228-1238. doi: 10.1111/jch.13909. Epub 2020 Jun 9.
Schroeder EB, Moore K, Manson SM, Baldwin MA, Goodrich GK, Malone AS, Pieper LE, Xu S, Fort MM, Johnson D, Son-Stone L, Steiner JF. An Interactive Voice Response and Text Message Intervention to Improve Blood Pressure Control Among Individuals With Hypertension Receiving Care at an Urban Indian Health Organization: Protocol and Baseline Characteristics of a Pragmatic Randomized Controlled Trial. JMIR Res Protoc. 2019 Apr 2;8(4):e11794. doi: 10.2196/11794.
Other Identifiers
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