NCT03135405

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
295

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 11, 2017

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 27, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 1, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

May 9, 2019

Status Verified

May 1, 2019

Enrollment Period

1.9 years

First QC Date

April 27, 2017

Last Update Submit

May 7, 2019

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Systolic blood pressure

    Change in systolic blood pressure from baseline

    12-months

Secondary Outcomes (3)

  • Diastolic blood pressure

    12-months

  • Medication adherence

    12-months

  • Visit adherence

    12-months

Study Arms (2)

Usual care

NO INTERVENTION

Intervention

EXPERIMENTAL
Behavioral: Automated messagesBehavioral: Home BP monitorsBehavioral: Care partner reminders

Interventions

Automated messagesBEHAVIORAL

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

Intervention
Home BP monitorsBEHAVIORAL

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

Intervention
Care partner remindersBEHAVIORAL

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

Intervention

Eligibility Criteria

Age21 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First National Community Healthsource

Albuquerque, New Mexico, 87108, United States

Location

Related Publications (2)

  • 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.

    PMID: 32516486DERIVED

  • 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.

    PMID: 30938688DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Emily B Schroeder, MD, PhD

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

April 27, 2017

First Posted

May 1, 2017

Study Start

April 11, 2017

Primary Completion

February 28, 2019

Study Completion

February 28, 2019

Last Updated

May 9, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)