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Controlling Hypertension in Native American and Other Populations

Primary Purpose

Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Automated messages
Home BP monitors
Care partner reminders
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypertension

Eligibility Criteria

21 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • First National Community Healthsource

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual care

Intervention

Arm Description

Outcomes

Primary Outcome Measures

Systolic blood pressure
Change in systolic blood pressure from baseline

Secondary Outcome Measures

Diastolic blood pressure
Change in diastolic blood pressure from baseline
Medication adherence
Self-reported medication adherence using the Voils instrument
Visit adherence
Proportion of scheduled appointments that are kept, missed or cancelled

Full Information

First Posted
April 27, 2017
Last Updated
May 7, 2019
Sponsor
Kaiser Permanente
Collaborators
American Heart Association, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT03135405
Brief Title
Controlling Hypertension in Native American and Other Populations
Official Title
Controlling Hypertension in Native American and Other Populations
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
April 11, 2017 (Actual)
Primary Completion Date
February 28, 2019 (Actual)
Study Completion Date
February 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaiser Permanente
Collaborators
American Heart Association, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
295 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm Title
Intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Automated messages
Intervention Description
Automated motivational messages and visit and medication reminders will be provided via interactive voice response calls or text messages.
Intervention Type
Behavioral
Intervention Name(s)
Home BP monitors
Intervention Description
Participants will have the option of receiving home blood pressure monitors.
Intervention Type
Behavioral
Intervention Name(s)
Care partner reminders
Intervention Description
Participants will have the option of designating a care partner who will also receive automated reminder calls or text messages.
Primary Outcome Measure Information:
Title
Systolic blood pressure
Description
Change in systolic blood pressure from baseline
Time Frame
12-months
Secondary Outcome Measure Information:
Title
Diastolic blood pressure
Description
Change in diastolic blood pressure from baseline
Time Frame
12-months
Title
Medication adherence
Description
Self-reported medication adherence using the Voils instrument
Time Frame
12-months
Title
Visit adherence
Description
Proportion of scheduled appointments that are kept, missed or cancelled
Time Frame
12-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily B Schroeder, MD, PhD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
First National Community Healthsource
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32516486
Citation
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.
Results Reference
derived
PubMed Identifier
30938688
Citation
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.
Results Reference
derived

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Controlling Hypertension in Native American and Other Populations

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