Controlling Hypertension in Native American and Other Populations

Hypertension Clinical Trial

Official title:

Controlling Hypertension in Native American and Other Populations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03135405
• Other study ID #: CO-16-2400
• Secondary ID: 2P30DK092923K23D
• Status: Completed
• Phase: N/A
• Start date: April 11, 2017
• Est. completion date: February 28, 2019

Study information

• Verified date: May 2019
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 295
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	First National Community Healthsource	Albuquerque	New Mexico

Sponsors (4)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic blood pressure	Change in systolic blood pressure from baseline	12-months
Secondary	Diastolic blood pressure	Change in diastolic blood pressure from baseline	12-months
Secondary	Medication adherence	Self-reported medication adherence using the Voils instrument	12-months
Secondary	Visit adherence	Proportion of scheduled appointments that are kept, missed or cancelled	12-months